- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07558421
The Effects of Exercise Snacks on Endothelial Function and Body Composition in Overweight Individuals
Přehled studie
Postavení
Detailní popis
This is a parallel group randomized controlled trial, with the study subjects being overweight or obese adults (with a body mass index of ≥ 24 kg/m²). Participants will be recruited from universities and randomly assigned to one of the following four groups:
Short-term stair climbing exercise group Participants climbed the stairs 4 to 5 times a day, each time ascending 5 floors (approximately 1 minute each time). There was at least a 1-hour interval between each exercise session, and the exercises were carried out during daily activities. They exercised 3 to 5 times a week for 6 to 8 weeks.
Long-term stair climbing nutrition supplementation group The participants also conducted 4 to 5 stair climbing training sessions every day. Each training session consisted of 3 sets of climbing 5 floors (the total climbing height for each training session was 15 floors), with a rest period of no more than 1 minute between each set. The interval between two training sessions was no less than 1 hour. They exercised 3 to 5 times a week for 6 to 8 weeks.
Moderate-intensity continuous training group (MICT) Participants engaged in 30-minute moderate-intensity running (including warm-up and cool-down activities) each time, 3 to 5 times a week, for 6 to 8 weeks.
Control group Participants maintained their daily activities and did not receive any exercise intervention measures.
Result measurement indicators:
Vascular health: Assessing endothelial function through ultrasound measurement of flow-mediated vascular dilation (FMD).
Body composition: Measured using the InBody body bioelectrical impedance analyzer (including muscle mass, fat mass and body fat percentage).
Blood lipid test: Collect fasting blood samples and measure low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides (TG), and total cholesterol (TC).
Measurement time points: Measurements were conducted at the baseline (at the beginning of the study), 3-4 weeks (during the intervention period), and 8 weeks (after the intervention ended).
This research protocol has been approved by the Institutional Review Board of Shandong Second Medical University. All participants are required to sign a written informed consent form.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: XINCHEN ZHANG
- Telefonní číslo: +8615094866869
- E-mail: zhangxinchen2001@126.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Age: 18-35 years old (male, female);
- Clear consciousness, stable vital signs;
- Able to understand and follow simple instructions;
- No regular exercise for at least 3 months;
- BMI ≥ 24 kg/m2.
Exclusion Criteria:
- There are other serious diseases, such as tumors;
- There are other neurological diseases;
- There are serious diseases that simultaneously affect the heart, liver, kidneys, endocrine system or hematopoietic system;
- There is a history of alcohol or drug abuse;
- Participated in other clinical trials that might affect the results of this study;
- There are other neurological or musculoskeletal diseases, with pain worsening with exercise;
- It is forbidden to engage in physical training.
- Within the past 3 months, there have been acute cardiovascular events such as acute myocardial infarction,unstable angina pectoris, severe arrhythmia, acute heart failure, etc.;
- Uncontrolled hypertension;
- Severe pulmonary diseases, such as uncontrolled asthma, acute exacerbation of chronic obstructive pulmonary disease, interstitial lung disease with significant exercise limitation;
- Severe joint and bone diseases, acute soft tissue injuries, fractures that have not healed, etc., making it impossible to complete the prescribed exercise load;
- Presence of bleeding tendencies, coagulation dysfunction, or within the past 1 month, there has been major bleeding or a history of surgery;
- The investigator judges that there are any other situations that may affect the safety of the subjects or the results of the trial.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Short-term stair climbing exercise snack group
Participants perform short climbs of the stairs 4 to 5 times a day.
Each climb involves going up 5 floors (approximately 1 minute), and there is a minimum interval of at least 1 hour between each climb.
|
Adopt a fragmented approach, climbing stairs 4-5 times a day, each time climbing 5 floors (approximately 1 minute per session), with at least 1 hour of interval between each session, and spread throughout the daily activity periods.
Exercise 3-5 days per week for a total of 6-8 weeks.
|
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Experimentální: Long-duration stair climbing exercise snack group
Participants climbed the ladder 4 to 5 times a day.
Each climb consisted of 2 to 3 sets (each set involved climbing 5 floors, with a rest period of no more than 1 minute between sets), and the total number of floors climbed in a single session was 10 or 15.
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On the basis of climbing stairs 4 to 5 times a day, increase the single exercise volume: complete 2 or 3 sets of climbing 5 floors of stairs each time (that is, the total number of floors climbed each time is 10 or 15), with no more than 1 minute of rest between sets.
The intervals between each exercise should be at least 1 hour.
Exercise 3 to 5 days a week, for a total of 6 to 8 weeks of intervention.
|
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Experimentální: Moderate-intensity continuous exercise
The participants engaged in moderate-intensity running training for 3 to 5 days per week, with each session lasting for 30 minutes.
|
Exercise 3 to 5 days per week for a total of 6 to 8 weeks.
Perform 30 minutes of moderate-intensity running training every day.
|
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Žádný zásah: control group
The participants did not undergo any form of exercise intervention and maintained their usual activity patterns.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Flow-mediated dilation (FMD, relative percentage)
Časové okno: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
Flow-mediated dilation expressed as a percentage of the baseline brachial artery diameter.Unit of Measure: %
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
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Body fat mass
Časové okno: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
Body fat mass measured by bioelectrical impedance analysis (InBody device).
Unit of Measure: kg
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Time to peak dilation
Časové okno: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
Time required to reach maximal dilation after cuff deflation.Unit of Measure: seconds
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Basal brachial artery diameter
Časové okno: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
Baseline diameter of the brachial artery before cuff inflation.Unit of Measure: mm
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Peak brachial artery diameter
Časové okno: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
Maximal diameter of the brachial artery after reactive hyperemia.Unit of Measure: mm
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Absolute flow-mediated dilation (FMDabs)
Časové okno: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
Absolute change in diameter, calculated as peak diameter minus basal diameter.Unit of Measure: mm
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Standardized FMD
Časové okno: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
Flow-mediated dilation adjusted for relevant covariates (e.g., shear stress, baseline diameter) according to standard protocols.Unit of Measure: %
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Body weight
Časové okno: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
Body weight measured by bioelectrical impedance analysis (InBody device).Unit of Measure: kg
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Body fat percentage
Časové okno: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
Body fat percentage measured by bioelectrical impedance analysis (InBody device).Unit of Measure: %
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Body mass index (BMI)
Časové okno: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
Body mass index calculated from weight and height measured by bioelectrical impedance analysis (InBody device).Unit of Measure: kg/m²
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Basal metabolic rate (BMR)
Časové okno: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Basal metabolic rate estimated by bioelectrical impedance analysis (InBody device).Unit of Measure: kcal
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Waist circumference
Časové okno: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
Waist circumference measured by bioelectrical impedance analysis (InBody device).Unit of Measure: cm
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
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Visceral fat area
Časové okno: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
Visceral fat area measured by bioelectrical impedance analysis (InBody device).
Unit of Measure: cm²
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
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Skeletal muscle mass
Časové okno: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
Skeletal muscle mass measured by bioelectrical impedance analysis (InBody device).Unit of Measure: kg
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Systolic blood pressure (SBP)
Časové okno: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
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Systolic blood pressure measured using an electronic sphygmomanometer.Unit of Measure: mmHg
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Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
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Serum high-density lipoprotein (HDL) cholesterol concentration
Časové okno: Measured at baseline and post-intervention (after 6-8 weeks).
|
Fasting serum HDL cholesterol concentration measured from blood samples.
Unit of Measure: mmol/L
|
Measured at baseline and post-intervention (after 6-8 weeks).
|
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Diastolic blood pressure (DBP)
Časové okno: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
Diastolic blood pressure measured using an electronic sphygmomanometer.
Unit of Measure: mmHg
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
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Heart rate
Časové okno: Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
Heart rate measured using an electronic sphygmomanometer.Unit of Measure: bpm (beats per minute)
|
Measured at baseline, mid-intervention (approximately 3-4 weeks), and post-intervention (after 6-8 weeks).
|
|
Serum low-density lipoprotein (LDL) cholesterol concentration
Časové okno: Measured at baseline and post-intervention (after 6-8 weeks).
|
Fasting serum LDL cholesterol concentration measured from blood samples.
Unit of Measure: mmol/L
|
Measured at baseline and post-intervention (after 6-8 weeks).
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Serum total cholesterol concentration
Časové okno: Measured at baseline and post-intervention (after 6-8 weeks).
|
Fasting serum total cholesterol concentration measured from blood samples.
Unit of Measure: mmol/L
|
Measured at baseline and post-intervention (after 6-8 weeks).
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HDL/LDL cholesterol ratio
Časové okno: Measured at baseline and post-intervention (after 6-8 weeks).
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Ratio of serum HDL cholesterol to LDL cholesterol calculated from fasting blood samples.Unit of Measure: ratio (dimensionless)
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Measured at baseline and post-intervention (after 6-8 weeks).
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Serum triglyceride concentration
Časové okno: Measured at baseline and post-intervention (after 6-8 weeks).
|
Fasting serum triglyceride concentration measured from blood samples.Unit of Measure: mmol/L
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Measured at baseline and post-intervention (after 6-8 weeks).
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: YANXIA WANG, PhD, Weifang Medical University(Renamed Shandong Second Medical University)
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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