Effects of a 12-week Supervised Exercise Program Post Bariatric Surgery on Body Composition, Muscle Strength, and Insulin Resistance

NCT07651254 | Completed

• 2 other identifiers: 20798273291
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bariatric Surgery; Exercise; Body Composition Changes

Keywords

Bariatric surgery; 6-minute walk test; Exercise; Heart rate variability; VO2 max; Physical activity; Insulin resistance

Outcome Measures

Primary Outcomes (22)

• Change in abdominal adipose tissue (visceral) as measured by computed tomography (cm2)

  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

• Change in abdominal adipose tissue (subcutaneous) as measured by computed tomography (cm2)

  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

• Change in thigh muscle tissue (normal density) as measured by computed tomography (cm2)

  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

• Change in thigh adipose tissue (subcutaneous) as measured by computed tomography (cm2)

  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

• Change in thigh adipose tissue (deep) as measured by computed tomography (cm2)

  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

• Muscular strength (upper-limb) assessed through handgrip via maximal voluntary contraction (kg)

  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.

  Before surgery and 3, 6 and 12 months post surgery

• Muscular relative strength (upper-limb) assessed through handgrip via maximal voluntary contraction (ratio)

  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.

  Before surgery and 3, 6 and 12 months post surgery

• Muscular strength (lower-limb) assessed through the femoral quadriceps via maximal voluntary contraction (Nm)

  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.

  Before surgery and 3, 6 and 12 months post surgery

• Muscular relative strength (lower-limb) assessed through the femoral quadriceps via maximal voluntary contraction (Nm/kg)

  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).

  Before surgery and 3, 6 and 12 months post surgery

• Change in insulin resistance (HOMA-IR)

  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.

  Before surgery and 3, 6 and 12 months post surgery

• Cardiac structure - Left ventricular mass (absolute) as assessed by transthoracic echocardiogram (g)

  Before surgery and 3, 6 and 12 months post surgery

• Cardiac structure - Left ventricular mass (relative) as assessed by transthoracic echocardiogram (g/m2)

  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)

  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

• Heart rate Variability - Time (SDNN) as assessed by a 24-hour Holter (ms)

  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

• Heart rate Variability - Time (SDRR) as assessed by a 24-hour Holter (ms)

  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

• Heart rate Variability - Time (SDANN) as assessed by a 24-hour Holter (ms)

  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

• Heart rate Variability - Time (pNN50) as assessed by a 24-hour Holter (ms)

  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

• Heart rate Variability - Time (RMSSD) as assessed by a 24-hour Holter (ms)

  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

• Heart rate Variability - Frequency (VLF power) as assessed by a 24-hour Holter (ms2)

  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

• Heart rate Variability - Frequency (LF power) as assessed by a 24-hour Holter (ms2)

  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

• Heart rate Variability - Frequency (HF power) as assessed by a 24-hour Holter (ms2)

  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

• Heart rate Variability - Frequency (LF/HF) as assessed by a 24-hour Holter (ratio)

  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

Secondary Outcomes (60)

• 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

Study Arms (2)

Control group

NO INTERVENTION

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

EXPERIMENTAL

Other: 12-week supervised exercise program

Interventions

12-week supervised exercise program OTHER

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).

Exercise group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 18 years and older
• Have a weight lower than 200 kg
• Interested in participating in a supervised training program

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Québec, Quebec, G1V4G5, Canada

Location

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  PMID: 26660319 RESULT

MeSH Terms

Conditions

Motor Activity; Insulin Resistance

Condition Hierarchy (Ancestors)

Behavior; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Paul Poirier, MD

  Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Model Details: 30 participants with a mixed bariatric surgery, and another 30 from with a restrictive bariatric surgery will be randomised to either the training (n=20 per surgery type) or control group (n=10 per surgery type) , for a total of 60 participants.

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 16, 2026
• Study Start: October 22, 2012
• Primary Completion: October 10, 2016
• Study Completion: October 10, 2016
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)