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)
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Quebec
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Québec, Quebec, 캐나다, G1V4G5
- Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 운동 그룹
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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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간섭 없음: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in abdominal adipose tissue (visceral) as measured by computed tomography (cm2)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Functional capacity using the 6MWT - Total distance walked (m)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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; %)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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 (%)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: Before surgery and 3, 6 and 12 months post surgery
|
Maximal voluntary ventilation (MVV) will be measured before the maximal graded exercise test, in L/min.
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Before surgery and 3, 6 and 12 months post surgery
|
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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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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)
기간: 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)
기간: Before surgery and 3, 6 and 12 months post surgery
|
Before surgery and 3, 6 and 12 months post surgery
|
|
|
Biomarkers - Potassium (mmol/L)
기간: Before surgery and 3, 6 and 12 months post surgery
|
Before surgery and 3, 6 and 12 months post surgery
|
|
|
Biomarkers - Chloride (mmol/L)
기간: Before surgery and 3, 6 and 12 months post surgery
|
Before surgery and 3, 6 and 12 months post surgery
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Paul Poirier, MD, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
간행물 및 유용한 링크
일반 간행물
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- 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.
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- 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.
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- 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.
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- 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.
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- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 20798
- 273291 (기타 보조금/기금 번호: Canadian Institutes of Health Research)
개별 참가자 데이터(IPD) 계획
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