AzTrials
AzTrials

Bariatric SurgeryACTIVENCT07651254

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

A study testing 12-week supervised exercise program in people with Bariatric Surgery and Exercise, run by Laval University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
12-week supervised exercise program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteCanada
Study dates
22 Oct 2012to 10 Oct 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

    Québec, Quebec, G1V4G5

Other trials in Canada

About this study

Official title: 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)

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.

Being tested
12-week supervised exercise program
Keywords
Bariatric surgery, 6-minute walk test, Exercise, Heart rate variability, VO2 max, Physical activity, Insulin resistance
Medical subject headings
Motor Activity, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 12-week supervised exercise programOther

    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).

Study groups in NCT07651254
Study groupRoleWhat they receive
Control groupNo intervention1 hour consultation with a kinesiologist. During this session, they will receive general advice on physical activity as well as healthy lifestyle habits.
Exercise groupExperimentalNot described
Receives: Other: 12-week supervised exercise program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  2. 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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  3. 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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  4. 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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  5. 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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  6. 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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  7. 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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  8. 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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  9. 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).

    Measured: Before surgery and 3, 6 and 12 months post surgery

  10. 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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

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

    Measured: Before surgery and 3, 6 and 12 months post surgery

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

    Measured: Before surgery and 3, 6 and 12 months post surgery

  13. 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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  14. 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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  15. 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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  16. 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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  17. 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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  18. 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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  19. 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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  20. 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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  21. 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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  22. 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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

Secondary outcomes (60)

  1. Functional capacity using the 6MWT - Total distance walked (m)

    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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  2. Aerobic capacity using the 6MWT - Weight relative VO2peak (mL/kg/min)

    Aerobic capacity is measured with the weight relative VO2peak (mL/kg/min) during the 6MWT.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  3. Aerobic capacity using the 6MWT - Fat-free mass relative VO2peak (mL/kg/min)

    Aerobic capacity is measured with the fat-free mass relative VO2peak (mL/kg/min) during the 6MWT.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  4. Aerobic capacity using the 6MWT - Absolute VO2peak (mL/min)

    Aerobic capacity is measured with the absolute VO2peak (mL/min) during the 6MWT.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  5. Physical activity measurement - Total energy expenditure as assessed by an armband monitor (kcal)

    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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  6. Functional capacity using the sit-to-stand test (rep)

    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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  7. Biomarkers - Sodium (mmol/L)

    Measured: Before surgery and 3, 6 and 12 months post surgery

  8. Biomarkers - Urea (mmol/L)

    Measured: Before surgery and 3, 6 and 12 months post surgery

  9. Biomarkers - Creatinine (µmol/L)

    Measured: Before surgery and 3, 6 and 12 months post surgery

  10. Biomarkers - EGFR (mL/min/1,73m2)

    Measured: Before surgery and 3, 6 and 12 months post surgery

  11. Biomarkers - Glucose (mmol/l)

    Measured: Before surgery and 3, 6 and 12 months post surgery

  12. Biomarkers - Insulin (pmol/L)

    Measured: Before surgery and 3, 6 and 12 months post surgery

  13. Biomarkers - Glycated hemoglobin (HbA1c; %)

    Measured: Before surgery and 3, 6 and 12 months post surgery

  14. Biomarkers - High-density lipoproteins (HDL; mmol/L)

    Measured: Before surgery and 3, 6 and 12 months post surgery

  15. Biomarkers - Low-density lipoproteins (LDL; mmol/L)

    Measured: Before surgery and 3, 6 and 12 months post surgery

  16. Biomarkers - Total cholesterol (mmol/L)

    Measured: Before surgery and 3, 6 and 12 months post surgery

  17. Biomarkers - Triglycerides (mmol/L)

    Measured: Before surgery and 3, 6 and 12 months post surgery

  18. Biomarkers - Apolipoprotein B (g/L)

    Measured: Before surgery and 3, 6 and 12 months post surgery

  19. Biomarkers - Calcium (mmol/L)

    Measured: Before surgery and 3, 6 and 12 months post surgery

  20. Biomarkers - Magnesium (mmol/L)

    Measured: Before surgery and 3, 6 and 12 months post surgery

  21. Biomarkers - Phosphate (U/L)

    Measured: Before surgery and 3, 6 and 12 months post surgery

  22. Biomarkers - Parathyroid hormone (TSH; mU/L)

    Measured: Before surgery and 3, 6 and 12 months post surgery

  23. Biomarkers - Vitamin A (µmol/L)

    Measured: Before surgery and 3, 6 and 12 months post surgery

  24. Anthropometric measures - Body weight (kg)

    Body composition will be assessed using a Tanita bioelectrical impedance scale, providing a measure of body weight in kg.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  25. Anthropometric measures - Body fat (%)

    Body composition will be assessed using a Tanita bioelectrical impedance scale, providing a measure of body fat as a percentage.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  26. Physical activity measurement - Total physical activity duration as assessed by an armband monitor (minutes)

    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)

    Measured: Before surgery and 3, 6 and 12 months post surgery

  27. Physical activity measurement - Total light physical activity duration as assessed by an armband monitor (minutes)

    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).

    Measured: Before surgery and 3, 6 and 12 months post surgery

  28. Physical activity measurement - Total moderate-to-vigorous physical activity duration as assessed by an armband monitor (minutes)

    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)

    Measured: Before surgery and 3, 6 and 12 months post surgery

  29. Anthropometric measures - Lean mass (kg)

    Body composition will be assessed using a Tanita bioelectrical impedance scale, providing a measure of lean mass in kg.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  30. Anthropometric measures - Fat mass (kg)

    Body composition will be assessed using a Tanita bioelectrical impedance scale, providing a measure of fat mass in kg.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  31. Anthropometric measures - Body water (kg)

    Body composition will be assessed using a Tanita bioelectrical impedance scale, providing a measure of body water in kg.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  32. Anthropometric measures - BMI (kg/m²)

    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).

    Measured: Before surgery and 3, 6 and 12 months post surgery

  33. Anthropometric measures - Waist circumference (cm)

    Waist circumference will be measured at the level of the iliac crests using a flexible measuring tape (cm).

    Measured: Before surgery and 3, 6 and 12 months post surgery

  34. FVC as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (L)

    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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  35. FEV1 as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (L)

    Forced expiratory volume in one second (FEV1) will be measured before the maximal graded exercise test, in L.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  36. MVV as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (L/min)

    Maximal voluntary ventilation (MVV) will be measured before the maximal graded exercise test, in L/min.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  37. 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)

    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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  38. 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)

    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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  39. Anaerobic threshold VO2 (absolute VO2) as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (mL/min)

    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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  40. Anaerobic threshold VE as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (L/min)

    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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  41. Anaerobic threshold RER as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (ratio)

    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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  42. Anaerobic threshold work load as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (Watts)

    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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  43. Anaerobic threshold heart rate as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (bpm)

    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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  44. 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)

    Multiple measures will help determine the weight relative VO2peak (mL/kg/min) during the maximal graded exercise test.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  45. Maximal aerobic capacity (absolute VO2peak) as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (mL/min)

    Multiple measures will help determine the absolute VO2peak (mL/min) during the maximal graded exercise test.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  46. 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)

    Multiple measures will help determine the fat-free mass relative VO2peak (mL/kg/min) during the maximal graded exercise test.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  47. RER at VO2peak as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (ratio)

    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.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  48. VE at VO2peak as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (ratio)

    Multiple measures will help determine the VO2peak during the maximal graded exercise test, where ventilation (VE; L/min), will be examined.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  49. Work load at VO2peak as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (Watts)

    Multiple measures will help determine the VO2peak during the maximal graded exercise test, where work load (Watts), will be examined.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  50. Heart rate at VO2peak as measured during a maximal graded exercise test using a ramp protocol on an cycle ergometer (bpm)

    Multiple measures will help determine the VO2peak during the maximal graded exercise test, where Heart rate (bpm), will be examined.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  51. Aerobic capacity using the 6MWT - Absolute VO2 (mL/min) at 0%, 25%, 50%, 75%, 100% of the test.

    Aerobic capacity is measured with the absolute VO2 (mL/min) at 0%, 25%, 50%, 75%, 100% of the 6MWT.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  52. Aerobic capacity using the 6MWT - Fat-free mass relative VO2 (mL/kg/min) at 0%, 25%, 50%, 75%, 100% of the test.

    Aerobic capacity is measured with the fat-free mass relative VO2 (mL/kg/min) at 0%, 25%, 50%, 75%, 100% of the 6MWT.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  53. Aerobic capacity using the 6MWT - Weight relative VO2 (mL/kg/min) at 0%, 25%, 50%, 75%, 100% of the test.

    Aerobic capacity is measured with the weight relative VO2 (mL/kg/min) at 0%, 25%, 50%, 75%, 100% of the 6MWT.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  54. Aerobic capacity using the 6MWT - VE (L/min) at the VO2peak.

    Aerobic capacity is measured with the ventilation (VE; L/min) at the VO2peak of the 6MWT.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  55. Aerobic capacity using the 6MWT - RER (ratio) at the VO2peak.

    Aerobic capacity is measured with the respiratory exchange rate (ration) at the VO2peak of the 6MWT, calculated as VCO2/VO2.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  56. Aerobic capacity using the 6MWT - Heart rate (bpm) at the VO2peak.

    Aerobic capacity is measured with the heart rate (bpm) at the VO2peak of the 6MWT.

    Measured: Before surgery and 3, 6 and 12 months post surgery

  57. Biomarkers - Vitamin B12 (pmol/L)

    Measured: Before surgery and 3, 6 and 12 months post surgery

  58. Biomarkers - Vitamin D (nmol/L)

    Measured: Before surgery and 3, 6 and 12 months post surgery

  59. Biomarkers - Potassium (mmol/L)

    Measured: Before surgery and 3, 6 and 12 months post surgery

  60. Biomarkers - Chloride (mmol/L)

    Measured: Before surgery and 3, 6 and 12 months post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2026
  2. Study start22 Oct 2012
  3. Primary completion10 Oct 2016
  4. Study completion10 Oct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07651254
Sponsor's protocol ID
20798
Other IDs
273291
Acronym
ACTIVE
Status last verified
Jun 2026
First submitted
1 Jun 2026
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Edward T HB, Don Franks. Fitness Professional's Handbook. 5th ed2007.

  • De Cristofaro P PA, Dragani B, Malatesta G, Arzeni S, Luciani M, Malavolti M, Battistini N. Total Energy Expenditure In Morbidly Obese Subjects: A New Device Validation. Obes Res. 2005;13:A175.

  • Guide du conseiller en condition physique et habitudes de vie: programme santé et condition physique de la Société canadienne de physiologie de l'exercice. 3e édition ed2004.

  • ACSM's Resource Manual for Guidelines for Exercise Testing and Prescription. 6th edition ed2010.

  • Jakicic JM, Marcus M, Gallagher KI, Randall C, Thomas E, Goss FL, Robertson RJ. Evaluation of the SenseWear Pro Armband to assess energy expenditure during exercise. Med Sci Sports Exerc. 2004 May;36(5):897-904. doi: 10.1249/01.mss.0000126805.32659.43.

    PubMed 15126727

  • St-Onge M, Mignault D, Allison DB, Rabasa-Lhoret R. Evaluation of a portable device to measure daily energy expenditure in free-living adults. Am J Clin Nutr. 2007 Mar;85(3):742-9. doi: 10.1093/ajcn/85.3.742.

    PubMed 17344495

  • Heil DP, Brage S, Rothney MP. Modeling physical activity outcomes from wearable monitors. Med Sci Sports Exerc. 2012 Jan;44(1 Suppl 1):S50-60. doi: 10.1249/MSS.0b013e3182399dcc.

    PubMed 22157775

  • Norman K, Stobaus N, Gonzalez MC, Schulzke JD, Pirlich M. Hand grip strength: outcome predictor and marker of nutritional status. Clin Nutr. 2011 Apr;30(2):135-42. doi: 10.1016/j.clnu.2010.09.010. Epub 2010 Oct 30.

    PubMed 21035927

  • 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.

    PubMed 12091180

  • Ross RM. ATS/ACCP statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 May 15;167(10):1451; author reply 1451. doi: 10.1164/ajrccm.167.10.950. No abstract available.

    PubMed 12738602

  • Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

    PubMed 7154893

  • Mountford PJ, Temperton DH. Recommendations of the International Commission on Radiological Protection (ICRP) 1990. Eur J Nucl Med. 1992;19(2):77-9. doi: 10.1007/BF00184120. No abstract available.

    PubMed 1563443

  • Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.

    PubMed 8737210

  • Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.

    PubMed 3899825

  • Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults--The Evidence Report. National Institutes of Health. Obes Res. 1998 Sep;6 Suppl 2:51S-209S. No abstract available.

    PubMed 9813653

Questions about this trial

What is this clinical trial studying?

A study testing 12-week supervised exercise program in people with Bariatric Surgery and Exercise, run by Laval University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in abdominal adipose tissue (visceral) as measured by computed tomography (cm2) (time frame: Before surgery and 3, 6 and 12 months post surgery). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07651254, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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