Effects of a 12-week Supervised Exercise Program Post Bariatric Surgery on Body Composition, Muscle Strength, and Insulin Resistance (ACTIVE)
Impact de différents Programmes d'entraînement Sur Les Changements de la Composition Corporelle, de la Force Musculaire et du Profil d'Insulino-résistance, Entre Les Mois 3 et 6 Suivant Une dérivation biliopancréatique Avec Commutation duodénale (ACTIVE)
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Quebec
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Québec、Quebec、カナダ、G1V4G5
- Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Be 18 years and older
- Have a weight lower than 200 kg
- Interested in participating in a supervised training program
Exclusion Criteria:
- Having undergone a vagotomy
- Having undergone a bariatric surgery
- Having used orlistat in the past three months
- Having a major cognitive imparment that may limit adherence to study visits
- Having a pacemaker
- Having a total hip replacement
- Being claustrophobic
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：運動会
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The exercise program will take place at the Pavillon de Prévention des Maladies Cardiaques, following a personalised exercise program with at least 3 scheduled 60-minute training sessions every week. The ACSM certified kinesiologist in charge of patients will adjust the progression of patients programs on a weekly basis, based on their needs. Length and intensity of training will increase in the first three weeks. The first week will have 20 minutes of cardio (40-60% reserve heart rate) and 10 minutes of muscle training (2 series of 10-15 repetitions). The second week will have a 30 minutes of cardio and 15 minutes of muscle training (2 series of 10-15 repetitions). The third week will have 35 minutes of cardio (50-75% reserve heart rate) and 25 minutes of muscle training (3 series of 10-15 repetitions). |
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介入なし：Control group
1 hour consultation with a kinesiologist.
During this session, they will receive general advice on physical activity as well as healthy lifestyle habits.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change in abdominal adipose tissue (visceral) as measured by computed tomography (cm2)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Change in abdominal adipose tissue (visceral adipose tissue) as measured by computed tomography (Siemens Somaton DRH). Image acquisition will follow a voltage between 120 and 140 kV (according to the subject's weight), a fixed tube current-time product set at 250 mAs, and a slice thickness of 10 mm. For the evaluation, subjects will be in the supine position with their arms extended above their head. CT will be performed at two locations. Midpoint between L2-L3; Midpoint between L4-L5. Analysis of the CT images will be performed using sliceOmatic 4.3 Rev-6f software. Resulting measurement unit is in cm2. |
Before surgery and 3, 6 and 12 months post surgery
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Change in abdominal adipose tissue (subcutaneous) as measured by computed tomography (cm2)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Change in abdominal adipose tissue (subcutaneous adipose tissue) as measured by computed tomography (Siemens Somaton DRH). Image acquisition will follow a voltage between 120 and 140 kV (according to the subject's weight), a fixed tube current-time product set at 250 mAs, and a slice thickness of 10 mm. For the evaluation, subjects will be in the supine position with their arms extended above their head. CT will be performed at two locations. Midpoint between L2-L3; Midpoint between L4-L5. Analysis of the CT images will be performed using sliceOmatic 4.3 Rev-6f software. Resulting measurement unit is in cm2. |
Before surgery and 3, 6 and 12 months post surgery
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Change in thigh muscle tissue (normal density) as measured by computed tomography (cm2)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Change in thigh normal density muscle tissue as measured by computed tomography (Siemens Somaton DRH). Image acquisition will follow a voltage between 120 and 140 kV (according to the subject's weight), a fixed tube current-time product set at 250 mAs, and a slice thickness of 10 mm. For the evaluation, subjects will be in the supine position with their arms extended above their head. At each visit, CT will be performed at the midpoint between iliac crest and tibial plateau. Analysis of the CT images will be performed using sliceOmatic 4.3 Rev-6f software. Resulting measurement unit is in cm2. |
Before surgery and 3, 6 and 12 months post surgery
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Change in thigh adipose tissue (subcutaneous) as measured by computed tomography (cm2)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Change in thigh subcutaneous adipose tissue as measured by computed tomography (Siemens Somaton DRH). Image acquisition will follow a voltage between 120 and 140 kV (according to the subject's weight), a fixed tube current-time product set at 250 mAs, and a slice thickness of 10 mm. For the evaluation, subjects will be in the supine position with their arms extended above their head. At each visit, CT will be performed at the midpoint between iliac crest and tibial plateau. Analysis of the CT images will be performed using sliceOmatic 4.3 Rev-6f software. Resulting measurement unit is in cm2. |
Before surgery and 3, 6 and 12 months post surgery
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Change in thigh adipose tissue (deep) as measured by computed tomography (cm2)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Change in thigh deep adipose tissue as measured by computed tomography (Siemens Somaton DRH). Image acquisition will follow a voltage between 120 and 140 kV (according to the subject's weight), a fixed tube current-time product set at 250 mAs, and a slice thickness of 10 mm. For the evaluation, subjects will be in the supine position with their arms extended above their head. At each visit, CT will be performed at the midpoint between iliac crest and tibial plateau. Analysis of the CT images will be performed using sliceOmatic 4.3 Rev-6f software. Resulting measurement unit is in cm2. |
Before surgery and 3, 6 and 12 months post surgery
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Muscular strength (upper-limb) assessed through handgrip via maximal voluntary contraction (kg)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Muscular upper-limb strength will be assessed with handgrip strength will be measured using a hydraulic hand dynamometer in kg, following the "Société canadienne de physiologie à l'exercice" protocol, as an indicator of upper-limb strength and functional capacity.
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Before surgery and 3, 6 and 12 months post surgery
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Muscular relative strength (upper-limb) assessed through handgrip via maximal voluntary contraction (ratio)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Muscular upper-limb strength (relative) will be assessed with handgrip strength, measured using a hydraulic hand dynamometer in kg divided by weight (kg), following the "Société canadienne de physiologie à l'exercice" protocol, as an indicator of upper-limb strength and functional capacity.
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Before surgery and 3, 6 and 12 months post surgery
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Muscular strength (lower-limb) assessed through the femoral quadriceps via maximal voluntary contraction (Nm)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Lower-limb strength will be evaluated via maximal voluntary contraction and muscular fatigue of the femoral quadriceps using an isokinetic dynamometer (Biodex System 4 Pro, Shirley, NY).
After a familiarization session, participants will perform a series of maximal concentric contractions (30 repetitions at 60°/s) to assess isokinetic strength and fatigue, followed by isometric maximal voluntary contractions at a fixed knee angle (80°) held for 4 seconds and repeated three times.
Measurements will be conducted bilaterally under standardized positioning and stabilization conditions, with consistent range of motion across all time points.
Strength is measured in Nm.
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Before surgery and 3, 6 and 12 months post surgery
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Muscular relative strength (lower-limb) assessed through the femoral quadriceps via maximal voluntary contraction (Nm/kg)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Lower-limb strength will be evaluated via maximal voluntary contraction and muscular fatigue of the femoral quadriceps using an isokinetic dynamometer (Biodex System 4 Pro, Shirley, NY).
After a familiarization session, participants will perform a series of maximal concentric contractions (30 repetitions at 60°/s) to assess isokinetic strength and fatigue, followed by isometric maximal voluntary contractions at a fixed knee angle (80°) held for 4 seconds and repeated three times.
Measurements will be conducted bilaterally under standardized positioning and stabilization conditions, with consistent range of motion across all time points.
Strength is measured in Nm and divided by weight (kg).
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Before surgery and 3, 6 and 12 months post surgery
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Change in insulin resistance (HOMA-IR)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Insulin resistance will be determined using the Homeostatic Model Assessment of insulin resistance (HOMA-IR), calculated as follows: fasting insulin (μU/mL) × fasting glucose (mmol/L) / 22,518.
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Before surgery and 3, 6 and 12 months post surgery
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Cardiac structure - Left ventricular mass (absolute) as assessed by transthoracic echocardiogram (g)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Before surgery and 3, 6 and 12 months post surgery
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Cardiac structure - Left ventricular mass (relative) as assessed by transthoracic echocardiogram (g/m2)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Before surgery and 3, 6 and 12 months post surgery
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Cardiac function - Diastolic function as assessed by transthoracic echocardiogram (function/dysfunction, 1 to 3 dysfunction grade scale)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Cardiac function is assessed through diastolic function. Diastolic function is assessed as being functional or dysfunctional. If dysfunctional, the dysfunction is graded on the scale of 1 to 3. A reduction in dysfunction equals to a lowering of the dysfunction grade or complete remission of prior dysfunction. Diastolic dysfunction presence and grade is determined with multiple parameters. |
Before surgery and 3, 6 and 12 months post surgery
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Heart rate Variability - Time (SDNN) as assessed by a 24-hour Holter (ms)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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The 24-hour recording will be divided into three periods: (1) the full 24-hour period, (2) the daytime period (8:00 AM to 8:00 PM), and (3) the nighttime period (12:00 AM to 6:00 AM). The nighttime period may vary according to individual differences in sleep and wake times. For the entire recording, a technician will remove artifacts around QRS complexes. |
Before surgery and 3, 6 and 12 months post surgery
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Heart rate Variability - Time (SDRR) as assessed by a 24-hour Holter (ms)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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The 24-hour recording will be divided into three periods: (1) the full 24-hour period, (2) the daytime period (8:00 AM to 8:00 PM), and (3) the nighttime period (12:00 AM to 6:00 AM). The nighttime period may vary according to individual differences in sleep and wake times. For the entire recording, a technician will remove artifacts around QRS complexes. |
Before surgery and 3, 6 and 12 months post surgery
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Heart rate Variability - Time (SDANN) as assessed by a 24-hour Holter (ms)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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The 24-hour recording will be divided into three periods: (1) the full 24-hour period, (2) the daytime period (8:00 AM to 8:00 PM), and (3) the nighttime period (12:00 AM to 6:00 AM). The nighttime period may vary according to individual differences in sleep and wake times. For the entire recording, a technician will remove artifacts around QRS complexes. |
Before surgery and 3, 6 and 12 months post surgery
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Heart rate Variability - Time (pNN50) as assessed by a 24-hour Holter (ms)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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The 24-hour recording will be divided into three periods: (1) the full 24-hour period, (2) the daytime period (8:00 AM to 8:00 PM), and (3) the nighttime period (12:00 AM to 6:00 AM). The nighttime period may vary according to individual differences in sleep and wake times. For the entire recording, a technician will remove artifacts around QRS complexes. |
Before surgery and 3, 6 and 12 months post surgery
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Heart rate Variability - Time (RMSSD) as assessed by a 24-hour Holter (ms)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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The 24-hour recording will be divided into three periods: (1) the full 24-hour period, (2) the daytime period (8:00 AM to 8:00 PM), and (3) the nighttime period (12:00 AM to 6:00 AM). The nighttime period may vary according to individual differences in sleep and wake times. For the entire recording, a technician will remove artifacts around QRS complexes. |
Before surgery and 3, 6 and 12 months post surgery
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Heart rate Variability - Frequency (VLF power) as assessed by a 24-hour Holter (ms2)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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The 24-hour recording will be divided into three periods: (1) the full 24-hour period, (2) the daytime period (8:00 AM to 8:00 PM), and (3) the nighttime period (12:00 AM to 6:00 AM). The nighttime period may vary according to individual differences in sleep and wake times. Very low frequency (VLF: 0.0033-0.04 Hz), reflecting parasympathetic, neuroendocrine, and thermogenic activity will be analyzed. |
Before surgery and 3, 6 and 12 months post surgery
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Heart rate Variability - Frequency (LF power) as assessed by a 24-hour Holter (ms2)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Description: The 24-hour recording will be divided into three periods: (1) the full 24-hour period, (2) the daytime period (8:00 AM to 8:00 PM), and (3) the nighttime period (12:00 AM to 6:00 AM). The nighttime period may vary according to individual differences in sleep and wake times. Low frequency (LF: 0.04-0.15 Hz), reflecting both sympathetic and parasympathetic activity will be analyzed. For the entire recording, a technician will remove artifacts around QRS complexes. |
Before surgery and 3, 6 and 12 months post surgery
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Heart rate Variability - Frequency (HF power) as assessed by a 24-hour Holter (ms2)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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The 24-hour recording will be divided into three periods: (1) the full 24-hour period, (2) the daytime period (8:00 AM to 8:00 PM), and (3) the nighttime period (12:00 AM to 6:00 AM). The nighttime period may vary according to individual differences in sleep and wake times. High frequency (HF: 0.15-0.4 Hz), reflecting parasympathetic activity, will be analyzed. For the entire recording, a technician will remove artifacts around QRS complexes. |
Before surgery and 3, 6 and 12 months post surgery
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Heart rate Variability - Frequency (LF/HF) as assessed by a 24-hour Holter (ratio)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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The 24-hour recording will be divided into three periods: (1) the full 24-hour period, (2) the daytime period (8:00 AM to 8:00 PM), and (3) the nighttime period (12:00 AM to 6:00 AM). The nighttime period may vary according to individual differences in sleep and wake times. The LF/HF ratio will be used to assess sympathovagal balance. For the entire recording, a technician will remove artifacts around QRS complexes. |
Before surgery and 3, 6 and 12 months post surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Functional capacity using the 6MWT - Total distance walked (m)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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All mentions of "6MWT" (6-minute walk test) in this study refers to the following description. The 6-minute walk test (6MWT) will be administered to all participants in both groups according to the American Thoracic Society guidelines. It will assess functional capacity and its changes over the course of the study. After standardized instructions, participants will be asked to walk as far as possible (without running or jumping) for six minutes. The test will take place in a corridor marked by two cones placed 30 meters apart. It will be administered by an ACSM-certified Clinical Exercise Specialist and supervised by a physician. During the test, participants will wear a portable system (≤2 kg) including a 12-lead electrocardiogram, a pulse oximeter, and a gas analyzer. Functional capacity is measured in total meters walked. |
Before surgery and 3, 6 and 12 months post surgery
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Aerobic capacity using the 6MWT - Weight relative VO2peak (mL/kg/min)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Aerobic capacity is measured with the weight relative VO2peak (mL/kg/min) during the 6MWT.
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Before surgery and 3, 6 and 12 months post surgery
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Aerobic capacity using the 6MWT - Fat-free mass relative VO2peak (mL/kg/min)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Aerobic capacity is measured with the fat-free mass relative VO2peak (mL/kg/min) during the 6MWT.
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Before surgery and 3, 6 and 12 months post surgery
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Aerobic capacity using the 6MWT - Absolute VO2peak (mL/min)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Aerobic capacity is measured with the absolute VO2peak (mL/min) during the 6MWT.
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Before surgery and 3, 6 and 12 months post surgery
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Physical activity measurement - Total energy expenditure as assessed by an armband monitor (kcal)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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A portable, wireless armband monitor (SenseWearPro2) will be used to measure energy expenditure. The armband will be worn for three consecutive days, including two weekdays and one weekend day. Participants will wear the device from waking until bedtime. The armband will not provide any feedback to the participant. The armband includes a biaxial accelerometer and multiple sensors used to estimate total energy expenditure. The accelerometer measures linear acceleration and deceleration of the body along horizontal and vertical axes. A heat flux sensor records heat dissipation to help differentiate activities. A skin temperature sensor measures skin temperature while accounting for ambient conditions. A galvanic skin response sensor measures skin impedance, reflecting its water content. Data is processed using proprietary alogirthms via the armband's software. |
Before surgery and 3, 6 and 12 months post surgery
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Functional capacity using the sit-to-stand test (rep)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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A sit-to-stand test will be performed.
It will be used to assess functional capacity as well as lower-limb strength and endurance.
Seated on a chair approximately 45-50 cm in height, with feet flat on the floor at shoulder width and arms crossed over the chest, participants will be asked to stand up and sit down as many times as possible over a continuous 30-second period (rep).
Prior to the test, participants may perform one to two practice repetitions.
The sit-to-stand test is associated with stair-climbing ability and walking speed and is a safe and sensitive tool to detect improvements in functional capacity resulting from an exercise program.
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Before surgery and 3, 6 and 12 months post surgery
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Biomarkers - Sodium (mmol/L)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Before surgery and 3, 6 and 12 months post surgery
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Biomarkers - Urea (mmol/L)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Before surgery and 3, 6 and 12 months post surgery
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Biomarkers - Creatinine (µmol/L)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Before surgery and 3, 6 and 12 months post surgery
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Biomarkers - EGFR (mL/min/1,73m2)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Before surgery and 3, 6 and 12 months post surgery
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Biomarkers - Glucose (mmol/l)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Before surgery and 3, 6 and 12 months post surgery
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Biomarkers - Insulin (pmol/L)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Before surgery and 3, 6 and 12 months post surgery
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Biomarkers - Glycated hemoglobin (HbA1c; %)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Before surgery and 3, 6 and 12 months post surgery
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Biomarkers - High-density lipoproteins (HDL; mmol/L)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Before surgery and 3, 6 and 12 months post surgery
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Biomarkers - Low-density lipoproteins (LDL; mmol/L)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Before surgery and 3, 6 and 12 months post surgery
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Biomarkers - Total cholesterol (mmol/L)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Before surgery and 3, 6 and 12 months post surgery
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Biomarkers - Triglycerides (mmol/L)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Before surgery and 3, 6 and 12 months post surgery
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Biomarkers - Apolipoprotein B (g/L)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Before surgery and 3, 6 and 12 months post surgery
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Biomarkers - Calcium (mmol/L)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Before surgery and 3, 6 and 12 months post surgery
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Biomarkers - Magnesium (mmol/L)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Before surgery and 3, 6 and 12 months post surgery
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Biomarkers - Phosphate (U/L)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Before surgery and 3, 6 and 12 months post surgery
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Biomarkers - Parathyroid hormone (TSH; mU/L)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Before surgery and 3, 6 and 12 months post surgery
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Biomarkers - Vitamin A (µmol/L)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Before surgery and 3, 6 and 12 months post surgery
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Anthropometric measures - Body weight (kg)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Body composition will be assessed using a Tanita bioelectrical impedance scale, providing a measure of body weight in kg.
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Before surgery and 3, 6 and 12 months post surgery
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Anthropometric measures - Body fat (%)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Body composition will be assessed using a Tanita bioelectrical impedance scale, providing a measure of body fat as a percentage.
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Before surgery and 3, 6 and 12 months post surgery
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Physical activity measurement - Total physical activity duration as assessed by an armband monitor (minutes)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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A portable, wireless armband monitor (SenseWearPro2) will be used to measure physical activity levels. The armband will be worn for three consecutive days, including two weekdays and one weekend day. Participants will wear the device from waking until bedtime. The armband will not provide any feedback to the participant. The armband includes a biaxial accelerometer and multiple sensors used to estimate to estimate the duration and intensity of physical activity The accelerometer measures linear acceleration and deceleration of the body along horizontal and vertical axes. A heat flux sensor records heat dissipation to help differentiate activities. A skin temperature sensor measures skin temperature while accounting for ambient conditions. A galvanic skin response sensor measures skin impedance, reflecting its water content. Data is processed using proprietary algorithms via the armband's software. Total physical activity duration (>1.5 METs) |
Before surgery and 3, 6 and 12 months post surgery
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Physical activity measurement - Total light physical activity duration as assessed by an armband monitor (minutes)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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A portable, wireless armband monitor (SenseWearPro2) will be used to measure physical activity levels. The armband will be worn for three consecutive days, including two weekdays and one weekend day. Participants will wear the device from waking until bedtime. The armband will not provide any feedback to the participant. The armband includes a biaxial accelerometer and multiple sensors used to estimate to estimate the duration and intensity of physical activity The accelerometer measures linear acceleration and deceleration of the body along horizontal and vertical axes. A heat flux sensor records heat dissipation to help differentiate activities. A skin temperature sensor measures skin temperature while accounting for ambient conditions. A galvanic skin response sensor measures skin impedance, reflecting its water content. Data is processed using proprietary algorithms via the armband's software. Total light physical activity duration (1.5 to 2.9 METs). |
Before surgery and 3, 6 and 12 months post surgery
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Physical activity measurement - Total moderate-to-vigorous physical activity duration as assessed by an armband monitor (minutes)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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A portable, wireless armband monitor (SenseWearPro2) will be used to measure physical activity levels. The armband will be worn for three consecutive days, including two weekdays and one weekend day. Participants will wear the device from waking until bedtime. The armband will not provide any feedback to the participant. The armband includes a biaxial accelerometer and multiple sensors used to estimate to estimate the duration and intensity of physical activity The accelerometer measures linear acceleration and deceleration of the body along horizontal and vertical axes. A heat flux sensor records heat dissipation to help differentiate activities. A skin temperature sensor measures skin temperature while accounting for ambient conditions. A galvanic skin response sensor measures skin impedance, reflecting its water content. Data is processed using proprietary algorithms via the armband's software. Total moderate-to-vigorous physical activity duration (≥3.0 METs) |
Before surgery and 3, 6 and 12 months post surgery
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Anthropometric measures - Lean mass (kg)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Body composition will be assessed using a Tanita bioelectrical impedance scale, providing a measure of lean mass in kg.
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Before surgery and 3, 6 and 12 months post surgery
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Anthropometric measures - Fat mass (kg)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Body composition will be assessed using a Tanita bioelectrical impedance scale, providing a measure of fat mass in kg.
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Before surgery and 3, 6 and 12 months post surgery
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Anthropometric measures - Body water (kg)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Body composition will be assessed using a Tanita bioelectrical impedance scale, providing a measure of body water in kg.
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Before surgery and 3, 6 and 12 months post surgery
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Anthropometric measures - BMI (kg/m²)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared (kg/m²).
Participants' height will be measured using a stadiometer (cm).
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Before surgery and 3, 6 and 12 months post surgery
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Anthropometric measures - Waist circumference (cm)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Waist circumference will be measured at the level of the iliac crests using a flexible measuring tape (cm).
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Before surgery and 3, 6 and 12 months post surgery
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FVC as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (L)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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The following description apllies to all outcomes mentioning "maximal graded exercise test". The test uses a ramp protocol on an electromagnetically braked recumbent cycle ergometer. Participants breathe through a mouthpiece connected to a gas analyzer. A 12-lead EKG will monitor cardiac activity, and a pulse oximeter will measure blood oxygen saturation. Perceived exertion using the modified Borg scale and BP will be measured every two minutes. After three minute of resting, then one minute of unloaded pedaling, workload will increase at a rate of 15 to 30 watts per minute, until maximal fatigue is reached or one or more termination criteria are met. The test is expected to last between eight and twelve minutes, with an ideal workload increment corresponding to 10% of the individual's maximal oxygen consumption per minute and a pedaling cadence between 60 and 120 revolutions per minute. Forced Vital Capacity (FVC) will be measured before the test, in L. |
Before surgery and 3, 6 and 12 months post surgery
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FEV1 as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (L)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Forced expiratory volume in one second (FEV1) will be measured before the maximal graded exercise test, in L.
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Before surgery and 3, 6 and 12 months post surgery
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MVV as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (L/min)
時間枠：Before surgery and 3, 6 and 12 months post surgery
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Maximal voluntary ventilation (MVV) will be measured before the maximal graded exercise test, in L/min.
|
Before surgery and 3, 6 and 12 months post surgery
|
|
Anaerobic threshold VO2 (weight relative VO2) as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (mL/kg/min)
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Multiple measures will help determine the anaerobic threshold (AT) during the maximal graded exercise test.
The Weight relative VO2 (mL/kg/min) will be examined at the AT.
|
Before surgery and 3, 6 and 12 months post surgery
|
|
Anaerobic threshold VO2 (fat-free mass relative VO2) as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (mL/kg/min)
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Multiple measures will help determine the anaerobic threshold (AT) during the maximal graded exercise test.
The fat-free mass relative VO2 (mL/kg/min) will be examined at the AT.
|
Before surgery and 3, 6 and 12 months post surgery
|
|
Anaerobic threshold VO2 (absolute VO2) as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (mL/min)
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Multiple measures will help determine the anaerobic threshold (AT) during the maximal graded exercise test.
The absolute VO2 (mL/min) will be examined at the AT.
|
Before surgery and 3, 6 and 12 months post surgery
|
|
Anaerobic threshold VE as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (L/min)
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Multiple measures will help determine the anaerobic threshold (AT) during the maximal graded exercise test.
The ventilation (VE; L/min) will be examined at the AT.
|
Before surgery and 3, 6 and 12 months post surgery
|
|
Anaerobic threshold RER as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (ratio)
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Multiple measures will help determine the anaerobic threshold (AT) during the maximal graded exercise test.
The respiratory exchange ratio (RER; ratio) will be examined, calculated as VCO2/VO2, at the AT.
|
Before surgery and 3, 6 and 12 months post surgery
|
|
Anaerobic threshold work load as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (Watts)
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Multiple measures will help determine the anaerobic threshold (AT) during the maximal graded exercise test.
The work load (Watts) will be examined at the AT.
|
Before surgery and 3, 6 and 12 months post surgery
|
|
Anaerobic threshold heart rate as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (bpm)
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Multiple measures will help determine the anaerobic threshold (AT) during the maximal graded exercise test.
The heart rate (bpm) will be examined at the AT.
|
Before surgery and 3, 6 and 12 months post surgery
|
|
Maximal aerobic capacity (weight relative VO2peak) as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (mL/kg/min)
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Multiple measures will help determine the weight relative VO2peak (mL/kg/min) during the maximal graded exercise test.
|
Before surgery and 3, 6 and 12 months post surgery
|
|
Maximal aerobic capacity (absolute VO2peak) as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (mL/min)
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Multiple measures will help determine the absolute VO2peak (mL/min) during the maximal graded exercise test.
|
Before surgery and 3, 6 and 12 months post surgery
|
|
Maximal aerobic capacity (fat-free mass relative VO2peak) as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (mL/kg/min)
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Multiple measures will help determine the fat-free mass relative VO2peak (mL/kg/min) during the maximal graded exercise test.
|
Before surgery and 3, 6 and 12 months post surgery
|
|
RER at VO2peak as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (ratio)
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Multiple measures will help determine the VO2peak during the maximal graded exercise test, where respiratory exchange ratio (ratio), calculated as VCO2/VO2, will be examined.
|
Before surgery and 3, 6 and 12 months post surgery
|
|
VE at VO2peak as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (ratio)
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Multiple measures will help determine the VO2peak during the maximal graded exercise test, where ventilation (VE; L/min), will be examined.
|
Before surgery and 3, 6 and 12 months post surgery
|
|
Work load at VO2peak as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (Watts)
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Multiple measures will help determine the VO2peak during the maximal graded exercise test, where work load (Watts), will be examined.
|
Before surgery and 3, 6 and 12 months post surgery
|
|
Heart rate at VO2peak as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (bpm)
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Multiple measures will help determine the VO2peak during the maximal graded exercise test, where Heart rate (bpm), will be examined.
|
Before surgery and 3, 6 and 12 months post surgery
|
|
Aerobic capacity using the 6MWT - Absolute VO2 (mL/min) at 0%, 25%, 50%, 75%, 100% of the test.
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Aerobic capacity is measured with the absolute VO2 (mL/min) at 0%, 25%, 50%, 75%, 100% of the 6MWT.
|
Before surgery and 3, 6 and 12 months post surgery
|
|
Aerobic capacity using the 6MWT - Fat-free mass relative VO2 (mL/kg/min) at 0%, 25%, 50%, 75%, 100% of the test.
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Aerobic capacity is measured with the fat-free mass relative VO2 (mL/kg/min) at 0%, 25%, 50%, 75%, 100% of the 6MWT.
|
Before surgery and 3, 6 and 12 months post surgery
|
|
Aerobic capacity using the 6MWT - Weight relative VO2 (mL/kg/min) at 0%, 25%, 50%, 75%, 100% of the test.
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Aerobic capacity is measured with the weight relative VO2 (mL/kg/min) at 0%, 25%, 50%, 75%, 100% of the 6MWT.
|
Before surgery and 3, 6 and 12 months post surgery
|
|
Aerobic capacity using the 6MWT - VE (L/min) at the VO2peak.
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Aerobic capacity is measured with the ventilation (VE; L/min) at the VO2peak of the 6MWT.
|
Before surgery and 3, 6 and 12 months post surgery
|
|
Aerobic capacity using the 6MWT - RER (ratio) at the VO2peak.
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Aerobic capacity is measured with the respiratory exchange rate (ration) at the VO2peak of the 6MWT, calculated as VCO2/VO2.
|
Before surgery and 3, 6 and 12 months post surgery
|
|
Aerobic capacity using the 6MWT - Heart rate (bpm) at the VO2peak.
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Aerobic capacity is measured with the heart rate (bpm) at the VO2peak of the 6MWT.
|
Before surgery and 3, 6 and 12 months post surgery
|
|
Biomarkers - Vitamin B12 (pmol/L)
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Before surgery and 3, 6 and 12 months post surgery
|
|
|
Biomarkers - Vitamin D (nmol/L)
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Before surgery and 3, 6 and 12 months post surgery
|
|
|
Biomarkers - Potassium (mmol/L)
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Before surgery and 3, 6 and 12 months post surgery
|
|
|
Biomarkers - Chloride (mmol/L)
時間枠：Before surgery and 3, 6 and 12 months post surgery
|
Before surgery and 3, 6 and 12 months post surgery
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Paul Poirier, MD、Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
出版物と役立つリンク
一般刊行物
- Ross RM. ATS/ACCP statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 May 15;167(10):1451; author reply 1451. doi: 10.1164/ajrccm.167.10.950. No abstract available.
- Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Egberts K, Brown WA, Brennan L, O'Brien PE. Does exercise improve weight loss after bariatric surgery? A systematic review. Obes Surg. 2012 Feb;22(2):335-41. doi: 10.1007/s11695-011-0544-5.
- Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.
- Christou NV, Sampalis JS, Liberman M, Look D, Auger S, McLean AP, MacLean LD. Surgery decreases long-term mortality, morbidity, and health care use in morbidly obese patients. Ann Surg. 2004 Sep;240(3):416-23; discussion 423-4. doi: 10.1097/01.sla.0000137343.63376.19.
- Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.
- Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults--The Evidence Report. National Institutes of Health. Obes Res. 1998 Sep;6 Suppl 2:51S-209S. No abstract available. Erratum In: Obes Res 1998 Nov;6(6):464.
- Fontaine KR, Redden DT, Wang C, Westfall AO, Allison DB. Years of life lost due to obesity. JAMA. 2003 Jan 8;289(2):187-93. doi: 10.1001/jama.289.2.187.
- Maggard MA, Shugarman LR, Suttorp M, Maglione M, Sugerman HJ, Livingston EH, Nguyen NT, Li Z, Mojica WA, Hilton L, Rhodes S, Morton SC, Shekelle PG. Meta-analysis: surgical treatment of obesity. Ann Intern Med. 2005 Apr 5;142(7):547-59. doi: 10.7326/0003-4819-142-7-200504050-00013.
- Chaston TB, Dixon JB, O'Brien PE. Changes in fat-free mass during significant weight loss: a systematic review. Int J Obes (Lond). 2007 May;31(5):743-50. doi: 10.1038/sj.ijo.0803483. Epub 2006 Oct 31.
- Ibrahim MM. Subcutaneous and visceral adipose tissue: structural and functional differences. Obes Rev. 2010 Jan;11(1):11-8. doi: 10.1111/j.1467-789X.2009.00623.x. Epub 2009 Jul 28.
- Fisher BL, Schauer P. Medical and surgical options in the treatment of severe obesity. Am J Surg. 2002 Dec;184(6B):9S-16S. doi: 10.1016/s0002-9610(02)01173-x.
- Poirier P, Giles TD, Bray GA, Hong Y, Stern JS, Pi-Sunyer FX, Eckel RH; American Heart Association; Obesity Committee of the Council on Nutrition, Physical Activity, and Metabolism. Obesity and cardiovascular disease: pathophysiology, evaluation, and effect of weight loss: an update of the 1997 American Heart Association Scientific Statement on Obesity and Heart Disease from the Obesity Committee of the Council on Nutrition, Physical Activity, and Metabolism. Circulation. 2006 Feb 14;113(6):898-918. doi: 10.1161/CIRCULATIONAHA.106.171016. Epub 2005 Dec 27.
- Despres JP, Moorjani S, Lupien PJ, Tremblay A, Nadeau A, Bouchard C. Regional distribution of body fat, plasma lipoproteins, and cardiovascular disease. Arteriosclerosis. 1990 Jul-Aug;10(4):497-511. doi: 10.1161/01.atv.10.4.497.
- Heil DP, Brage S, Rothney MP. Modeling physical activity outcomes from wearable monitors. Med Sci Sports Exerc. 2012 Jan;44(1 Suppl 1):S50-60. doi: 10.1249/MSS.0b013e3182399dcc.
- Poirier P, Cornier MA, Mazzone T, Stiles S, Cummings S, Klein S, McCullough PA, Ren Fielding C, Franklin BA; American Heart Association Obesity Committee of the Council on Nutrition, Physical Activity, and Metabolism. Bariatric surgery and cardiovascular risk factors: a scientific statement from the American Heart Association. Circulation. 2011 Apr 19;123(15):1683-701. doi: 10.1161/CIR.0b013e3182149099. Epub 2011 Mar 14. No abstract available.
- ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
- Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.
- Edward T HB, Don Franks. Fitness Professional's Handbook. 5th ed2007.
- De Cristofaro P PA, Dragani B, Malatesta G, Arzeni S, Luciani M, Malavolti M, Battistini N. Total Energy Expenditure In Morbidly Obese Subjects: A New Device Validation. Obes Res. 2005;13:A175.
- Guide du conseiller en condition physique et habitudes de vie: programme santé et condition physique de la Société canadienne de physiologie de l'exercice. 3e édition ed2004.
- ACSM's Resource Manual for Guidelines for Exercise Testing and Prescription. 6th edition ed2010.
- Jakicic JM, Marcus M, Gallagher KI, Randall C, Thomas E, Goss FL, Robertson RJ. Evaluation of the SenseWear Pro Armband to assess energy expenditure during exercise. Med Sci Sports Exerc. 2004 May;36(5):897-904. doi: 10.1249/01.mss.0000126805.32659.43.
- St-Onge M, Mignault D, Allison DB, Rabasa-Lhoret R. Evaluation of a portable device to measure daily energy expenditure in free-living adults. Am J Clin Nutr. 2007 Mar;85(3):742-9. doi: 10.1093/ajcn/85.3.742.
- Norman K, Stobaus N, Gonzalez MC, Schulzke JD, Pirlich M. Hand grip strength: outcome predictor and marker of nutritional status. Clin Nutr. 2011 Apr;30(2):135-42. doi: 10.1016/j.clnu.2010.09.010. Epub 2010 Oct 30.
- Mountford PJ, Temperton DH. Recommendations of the International Commission on Radiological Protection (ICRP) 1990. Eur J Nucl Med. 1992;19(2):77-9. doi: 10.1007/BF00184120. No abstract available.
- Jacobi D, Ciangura C, Couet C, Oppert JM. Physical activity and weight loss following bariatric surgery. Obes Rev. 2011 May;12(5):366-77. doi: 10.1111/j.1467-789X.2010.00731.x.
- Hoffstedt J, Arner E, Wahrenberg H, Andersson DP, Qvisth V, Lofgren P, Ryden M, Thorne A, Wiren M, Palmer M, Thorell A, Toft E, Arner P. Regional impact of adipose tissue morphology on the metabolic profile in morbid obesity. Diabetologia. 2010 Dec;53(12):2496-503. doi: 10.1007/s00125-010-1889-3. Epub 2010 Sep 10.
- Despres JP, Lemieux I, Bergeron J, Pibarot P, Mathieu P, Larose E, Rodes-Cabau J, Bertrand OF, Poirier P. Abdominal obesity and the metabolic syndrome: contribution to global cardiometabolic risk. Arterioscler Thromb Vasc Biol. 2008 Jun;28(6):1039-49. doi: 10.1161/ATVBAHA.107.159228. Epub 2008 Mar 20.
- Padwal R, Klarenbach S, Wiebe N, Birch D, Karmali S, Manns B, Hazel M, Sharma AM, Tonelli M. Bariatric surgery: a systematic review and network meta-analysis of randomized trials. Obes Rev. 2011 Aug;12(8):602-21. doi: 10.1111/j.1467-789X.2011.00866.x. Epub 2011 Mar 28.
- Kapoor S. Bariatric surgery for morbid obesity. N Engl J Med. 2007 Sep 13;357(11):1159; author reply 1159-60. No abstract available.
- Katzmarzyk PT, Mason C. Prevalence of class I, II and III obesity in Canada. CMAJ. 2006 Jan 17;174(2):156-7. doi: 10.1503/cmaj.050806. No abstract available.
- Auclair A, Martin J, Bastien M, Bonneville N, Biertho L, Marceau S, Hould FS, Biron S, Lebel S, Lescelleur O, Despres JP, Poirier P. Is There a Role for Visceral Adiposity in Inducing Type 2 Diabetes Remission in Severely Obese Patients Following Biliopancreatic Diversion with Duodenal Switch Surgery? Obes Surg. 2016 Aug;26(8):1717-27. doi: 10.1007/s11695-015-1973-3.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
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QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 20798
- 273291 (その他の助成金/資金番号：Canadian Institutes of Health Research)
個々の参加者データ (IPD) の計画
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12-week supervised exercise programの臨床試験
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Islamic Azad University, Sanandaj完了