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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Change in abdominal adipose tissue (visceral) as measured by computed tomography (cm2)
研究概览
简要总结
The goal of this clinical trial is to evaluate the impact of supervised training program on body composition, muscular strenght, insulino-resistance profile, heart rate variability and on heart structure and function between 3 to 6 months after mixed bariatric surgery or restrictive bariatric surgery. This study will be conducted in men and women with severe obesity. Respectively for each type of surgery (mixed vs. restrictive), participants will be randomized either to the exercise group or to the control group. For participant randomized in the exercise group, 3 months after the bariatric surgery, they will started a supervised exercise program for 3 months. In contrast, for participant randomized in the control group, they will have consultation with kinesiologist to receive general information about physical activity practice. Each participants will perform 4 evaluations; one before bariatric surgery and 3 after bariatric surgery (3 months, 6 months and 12 months). Thoses evaluations will be assessed at each visit : fasting blood draw, anthropometric measurements, cardiac echocardiography, heart rate variability measurement, mid-thigh and abdominal computed tomography scan, maximal exercise test, six-minute walk test, assessment of lower-limb endurance and strength, assessment of physical activity level and energy expenditure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18 years and older
- •Have a weight lower than 200 kg
- •Interested in participating in a supervised training program
排除标准
- •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
研究组 & 干预措施
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.
Exercise group
干预措施: 12-week supervised exercise program (Other)
结局指标
主要结局
Change in abdominal adipose tissue (visceral) as measured by computed tomography (cm2)
时间窗: Before surgery and 3, 6 and 12 months post surgery
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.
Change in abdominal adipose tissue (subcutaneous) as measured by computed tomography (cm2)
时间窗: Before surgery and 3, 6 and 12 months post surgery
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.
Change in thigh muscle tissue (normal density) as measured by computed tomography (cm2)
时间窗: Before surgery and 3, 6 and 12 months post surgery
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.
Change in thigh adipose tissue (subcutaneous) as measured by computed tomography (cm2)
时间窗: Before surgery and 3, 6 and 12 months post surgery
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.
Change in thigh adipose tissue (deep) as measured by computed tomography (cm2)
时间窗: Before surgery and 3, 6 and 12 months post surgery
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.
Muscular strength (upper-limb) assessed through handgrip via maximal voluntary contraction (kg)
时间窗: Before surgery and 3, 6 and 12 months post surgery
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.
Muscular relative strength (upper-limb) assessed through handgrip via maximal voluntary contraction (ratio)
时间窗: Before surgery and 3, 6 and 12 months post surgery
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.
Muscular strength (lower-limb) assessed through the femoral quadriceps via maximal voluntary contraction (Nm)
时间窗: Before surgery and 3, 6 and 12 months post surgery
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.
Muscular relative strength (lower-limb) assessed through the femoral quadriceps via maximal voluntary contraction (Nm/kg)
时间窗: Before surgery and 3, 6 and 12 months post surgery
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).
Change in insulin resistance (HOMA-IR)
时间窗: Before surgery and 3, 6 and 12 months post surgery
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.
Cardiac structure - Left ventricular mass (absolute) as assessed by transthoracic echocardiogram (g)
时间窗: Before surgery and 3, 6 and 12 months post surgery
Cardiac structure - Left ventricular mass (relative) as assessed by transthoracic echocardiogram (g/m2)
时间窗: Before surgery and 3, 6 and 12 months post surgery
Cardiac function - Diastolic function as assessed by transthoracic echocardiogram (function/dysfunction, 1 to 3 dysfunction grade scale)
时间窗: Before surgery and 3, 6 and 12 months post surgery
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.
Heart rate Variability - Time (SDNN) as assessed by a 24-hour Holter (ms)
时间窗: Before surgery and 3, 6 and 12 months post surgery
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.
Heart rate Variability - Time (SDRR) as assessed by a 24-hour Holter (ms)
时间窗: Before surgery and 3, 6 and 12 months post surgery
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.
Heart rate Variability - Time (SDANN) as assessed by a 24-hour Holter (ms)
时间窗: Before surgery and 3, 6 and 12 months post surgery
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.
Heart rate Variability - Time (pNN50) as assessed by a 24-hour Holter (ms)
时间窗: Before surgery and 3, 6 and 12 months post surgery
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.
Heart rate Variability - Time (RMSSD) as assessed by a 24-hour Holter (ms)
时间窗: Before surgery and 3, 6 and 12 months post surgery
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.
Heart rate Variability - Frequency (VLF power) as assessed by a 24-hour Holter (ms2)
时间窗: Before surgery and 3, 6 and 12 months post surgery
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.
Heart rate Variability - Frequency (LF power) as assessed by a 24-hour Holter (ms2)
时间窗: Before surgery and 3, 6 and 12 months post surgery
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.
Heart rate Variability - Frequency (HF power) as assessed by a 24-hour Holter (ms2)
时间窗: Before surgery and 3, 6 and 12 months post surgery
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.
Heart rate Variability - Frequency (LF/HF) as assessed by a 24-hour Holter (ratio)
时间窗: Before surgery and 3, 6 and 12 months post surgery
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.
次要结局
- Biomarkers - EGFR (mL/min/1,73m2)(Before surgery and 3, 6 and 12 months post surgery)
- Biomarkers - Glucose (mmol/l)(Before surgery and 3, 6 and 12 months post surgery)
- Functional capacity using the 6MWT - Total distance walked (m)(Before surgery and 3, 6 and 12 months post surgery)
- Aerobic capacity using the 6MWT - Weight relative VO2peak (mL/kg/min)(Before surgery and 3, 6 and 12 months post surgery)
- Aerobic capacity using the 6MWT - Fat-free mass relative VO2peak (mL/kg/min)(Before surgery and 3, 6 and 12 months post surgery)
- Aerobic capacity using the 6MWT - Absolute VO2peak (mL/min)(Before surgery and 3, 6 and 12 months post surgery)
- Physical activity measurement - Total energy expenditure as assessed by an armband monitor (kcal)(Before surgery and 3, 6 and 12 months post surgery)
- Functional capacity using the sit-to-stand test (rep)(Before surgery and 3, 6 and 12 months post surgery)
- Biomarkers - Sodium (mmol/L)(Before surgery and 3, 6 and 12 months post surgery)
- Biomarkers - Urea (mmol/L)(Before surgery and 3, 6 and 12 months post surgery)
- Biomarkers - Creatinine (µmol/L)(Before surgery and 3, 6 and 12 months post surgery)
- Biomarkers - Insulin (pmol/L)(Before surgery and 3, 6 and 12 months post surgery)
- Biomarkers - Glycated hemoglobin (HbA1c; %)(Before surgery and 3, 6 and 12 months post surgery)
- Biomarkers - High-density lipoproteins (HDL; mmol/L)(Before surgery and 3, 6 and 12 months post surgery)
- Biomarkers - Low-density lipoproteins (LDL; mmol/L)(Before surgery and 3, 6 and 12 months post surgery)
- Biomarkers - Total cholesterol (mmol/L)(Before surgery and 3, 6 and 12 months post surgery)
- Biomarkers - Triglycerides (mmol/L)(Before surgery and 3, 6 and 12 months post surgery)
- Biomarkers - Apolipoprotein B (g/L)(Before surgery and 3, 6 and 12 months post surgery)
- Biomarkers - Calcium (mmol/L)(Before surgery and 3, 6 and 12 months post surgery)
- Biomarkers - Magnesium (mmol/L)(Before surgery and 3, 6 and 12 months post surgery)
- Biomarkers - Phosphate (U/L)(Before surgery and 3, 6 and 12 months post surgery)
- Biomarkers - Parathyroid hormone (TSH; mU/L)(Before surgery and 3, 6 and 12 months post surgery)
- Biomarkers - Vitamin A (µmol/L)(Before surgery and 3, 6 and 12 months post surgery)
- Anthropometric measures - Body weight (kg)(Before surgery and 3, 6 and 12 months post surgery)
- Anthropometric measures - Body fat (%)(Before surgery and 3, 6 and 12 months post surgery)
- Physical activity measurement - Total physical activity duration as assessed by an armband monitor (minutes)(Before surgery and 3, 6 and 12 months post surgery)
- Physical activity measurement - Total light physical activity duration as assessed by an armband monitor (minutes)(Before surgery and 3, 6 and 12 months post surgery)
- Physical activity measurement - Total moderate-to-vigorous physical activity duration as assessed by an armband monitor (minutes)(Before surgery and 3, 6 and 12 months post surgery)
- Anthropometric measures - Lean mass (kg)(Before surgery and 3, 6 and 12 months post surgery)
- Anthropometric measures - Fat mass (kg)(Before surgery and 3, 6 and 12 months post surgery)
- Anthropometric measures - Body water (kg)(Before surgery and 3, 6 and 12 months post surgery)
- Anthropometric measures - BMI (kg/m²)(Before surgery and 3, 6 and 12 months post surgery)
- Anthropometric measures - Waist circumference (cm)(Before surgery and 3, 6 and 12 months post surgery)
- FVC as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (L)(Before surgery and 3, 6 and 12 months post surgery)
- FEV1 as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (L)(Before surgery and 3, 6 and 12 months post surgery)
- MVV as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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)(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.(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.(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.(Before surgery and 3, 6 and 12 months post surgery)
- Aerobic capacity using the 6MWT - VE (L/min) at the VO2peak.(Before surgery and 3, 6 and 12 months post surgery)
- Aerobic capacity using the 6MWT - RER (ratio) at the VO2peak.(Before surgery and 3, 6 and 12 months post surgery)
- Aerobic capacity using the 6MWT - Heart rate (bpm) at the VO2peak.(Before surgery and 3, 6 and 12 months post surgery)
- Biomarkers - Vitamin B12 (pmol/L)(Before surgery and 3, 6 and 12 months post surgery)
- Biomarkers - Vitamin D (nmol/L)(Before surgery and 3, 6 and 12 months post surgery)
- Biomarkers - Potassium (mmol/L)(Before surgery and 3, 6 and 12 months post surgery)
- Biomarkers - Chloride (mmol/L)(Before surgery and 3, 6 and 12 months post surgery)
研究者
Paul Poirier
Cardiologist
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval