Physical Activity and Bariatric Surgery

Study Overview
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Brief Summary
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Bariatric surgery indeed leads to significant weight loss, reduces mortality risk, obesity-associated comorbidities (Wolfe et al., 2016) and improves functional physical abilities (Herring et al., 2016). Because these benefits are related to decreased energy intake, the investigators aim to optimize them by combining them with supervised adapted physical activity practice. So, the aim of this clinical trial is to measure the effects of a physical training program on physical fitness, body composition and quality of life of obese women who have undergone bariatric surgery.

Detailed Description
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Upon hospitalization for their bariatric surgery (bypass or sleeve), subjects will sign their informed consent and be included in the study. Six weeks' post-surgery, the subjects will be randomized in one of the 2 groups (Control group CG or Adapted Physical Activity group APAG). Patients in both groups will have 3 postoperative visits one at 6 weeks (V1), one at 18 weeks (V2) and one at 30 weeks (V3). During these visits, they will undergo the same assessments (body composition, physical condition, quality of life). Patients in the CG will receive standard hospital management. Patients in APAG will follow the same management and will also follow a 3-month physical activity program 3 times a week between V1 and V2. Then, between V2 and V3, no APA program will be offered to both groups. The subjects will evaluate during each visit V1, V2 and V3: body composition, physical condition, quality of life daily physical activity

Official Title
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Effects of Controlled Physical Activity on the Fitness, Body Composition and Quality of Life of Obese Women Undergoing Bariatric Surgery

Conditions
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Bariatric Surgery Candidate

Intervention / Treatment
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* Other: Physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women between 18 and 55 years old undergoing bariatric surgery (a bypass gastric or a sleeve) not practicing a supervised physical activity having read and signed an informed consent prior to the start of the trial being affiliated to a social security system Exclusion Criteria: Women with a contraindication to physical activity any medical contraindication to the practice of stress tests. unable to go to the hospital regularly having a significant functional limitation that does not allow her to perform the 6-minute walk test with an intellectual disability and/or psychiatric illness does not speak and/or understand French pregnant woman under guardianship or curatorship participating in another clinical research

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is an open-label, randomized, single-center trial with two groups: an Adapted Physical Activity group and a control group performing no controlled physical activity within each group women undergoing bypass or sleeve surgery
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adapted Physical Activity Group<br>Patients will follow a 3-month physical activity program 3 times a week between V1 and V2. Then, between V2 and V3, no APA program will be offered to both groups. | Other: Physical activity<br>* Between V1 and V2 (i.e. 12 weeks), the APAG (Adapted Physical Activity Group) will participate at a physical training program, 3 sessions of 1h30 per week consisting of endurance activities (60-75% of VO2 peak) and muscle strengthening while the CG will not perform any controlled physical training program. Then, between V2 and V3, no APA (Adapted Physical Activity) program will be offered to both groups.<br>|
| No Intervention: Control group<br>Patients will receive standard hospital management | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum oxygen consumption (VO2 max) | The VO2 max is measured during an effort test with progressively increasing and maximum load which consists in making the subject pedal against an increasing load | Week 6 | 
| Maximum oxygen consumption (VO2 max) | The VO2 max is measured during an effort test with progressively increasing and maximum load which consists in making the subject pedal against an increasing load | Week 18 | 
| Maximum oxygen consumption (VO2 max) | The VO2 max is measured during an effort test with progressively increasing and maximum load which consists in making the subject pedal against an increasing load | Week 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of obesity on the physical, psycho-social, dietary well-being and dieting experience assessed using the Quality of Life, Obesity and Diet Scale (QOLDS) | QoL will be assessed using a simplified version of the French obesity-specific QoL questionnaire developed by Ziegler et al. Each participant will be asked to evaluate 14 statements about their life on a 4-point Likert scale (with 1 representing total disagreement and 4 representing total agreement). The 14 statements (eg, Because of my weight, I have trouble to dress or undress) will equally be divided between physical aspects of life and psychosocial aspects of life. A French obesity-specific QoL questionnaire will be used to calculate the participants' physical dimension of QoL scores and psychoso-cial dimension of QoL scores by summing the points for each relevant item (range: 7-28 points). The total score will also be calculated (range: 14-56 points). The higher the scores, the better the QoL. | Week 6 | 
| Impact of obesity on the physical, psycho-social, dietary well-being and dieting experience assessed using the Quality of Life, Obesity and Diet Scale (QOLDS) | QoL will be assessed using a simplified version of the French obesity-specific QoL questionnaire developed by Ziegler et al. Each participant will be asked to evaluate 14 statements about their life on a 4-point Likert scale (with 1 representing total disagreement and 4 representing total agreement). The 14 statements (eg, Because of my weight, I have trouble to dress or undress) will equally be divided between physical aspects of life and psychosocial aspects of life. A French obesity-specific QoL questionnaire will be used to calculate the participants' physical dimension of QoL scores and psychoso-cial dimension of QoL scores by summing the points for each relevant item (range: 7-28 points). The total score will also be calculated (range: 14-56 points). The higher the scores, the better the QoL. | Week 18 | 
| Impact of obesity on the physical, psycho-social, dietary well-being and dieting experience assessed using the Quality of Life, Obesity and Diet Scale (QOLDS) | QoL will be assessed using a simplified version of the French obesity-specific QoL questionnaire developed by Ziegler et al. Each participant will be asked to evaluate 14 statements about their life on a 4-point Likert scale (with 1 representing total disagreement and 4 representing total agreement). The 14 statements (eg, Because of my weight, I have trouble to dress or undress) will equally be divided between physical aspects of life and psychosocial aspects of life. A French obesity-specific QoL questionnaire will be used to calculate the participants' physical dimension of QoL scores and psychoso-cial dimension of QoL scores by summing the points for each relevant item (range: 7-28 points). The total score will also be calculated (range: 14-56 points). The higher the scores, the better the QoL. | Week 30 | 
| Walking distance | The walking distance (meters) will be evaluated during the 6 minutes walk test | Week 6 | 
| Walking distance | The walking distance (meters) will be evaluated during the 6 minutes walk test | Week 18 | 
| Walking distance | The walking distance (meters) will be evaluated during the 6 minutes walk test | Week 30 | 
| Heart rate | The heart rate (beats/min) will be evaluated during the 6 minutes walk test | Week 6 | 
| Heart rate | The heart rate (beats/min) will be evaluated during the 6 minutes walk test | Week 18 | 
| Heart rate | The heart rate (beats/min) will be evaluated during the 6 minutes walk test | Week 30 | 
| Perception of the effort | This will be evaluated with a Borg scale (the minimum score is 0 = no exertion and the maximal 10 = maximal exertion) at the end of the 6-minutes walk test. | Week 6 | 
| Perception of the effort | This will be evaluated with a Borg scale (the minimum score is 0 = no exertion and the maximal 10 = maximal exertion) at the end of the 6-minutes walk test. | Week 18 | 
| Perception of the effort | This will be evaluated with a Borg scale (the minimum score is 0 = no exertion and the maximal 10 = maximal exertion) at the end of the 6-minutes walk test. | Week 36 | 
| Maximum voluntary force of the quadriceps | The maximum voluntary isometric strength of the knee extensors (strength of quadriceps in kilograms) will be measured with a MicroFET2 handheld dynamometer. Each participant's lower extremity could be placed in a position a knee flexion of 90 degrees. They will be asked to apply maximal force against the dynamometer held by the physical therapist. Before the test, the participants will be given a standard instruction of push as hard as you can. Encouragement to apply maximal effort will also be given during the test. Each participant will be instructed to exert maximal strength for 3-5 seconds until the examiner instructed the patient to relax. | week 6 | 
| Maximum voluntary force of the quadriceps | The maximum voluntary isometric strength of the knee extensors (strength of quadriceps in kilograms) will be measured with a MicroFET2 handheld dynamometer. Each participant's lower extremity could be placed in a position a knee flexion of 90 degrees. They will be asked to apply maximal force against the dynamometer held by the physical therapist. Before the test, the participants will be given a standard instruction of push as hard as you can. Encouragement to apply maximal effort will also be given during the test. Each participant will be instructed to exert maximal strength for 3-5 seconds until the examiner instructed the patient to relax. | week 18 | 
| Maximum voluntary force of the quadriceps | The maximum voluntary isometric strength of the knee extensors (strength of quadriceps in kilograms) will be measured with a MicroFET2 handheld dynamometer. Each participant's lower extremity could be placed in a position a knee flexion of 90 degrees. They will be asked to apply maximal force against the dynamometer held by the physical therapist. Before the test, the participants will be given a standard instruction of push as hard as you can. Encouragement to apply maximal effort will also be given during the test. Each participant will be instructed to exert maximal strength for 3-5 seconds until the examiner instructed the patient to relax. | week 30 | 
| grip strength | The grip strength will be evaluated with a dynamometer that can be squeezed very hard for 3 seconds. The measurement will be evaluated three times with 30 seconds of recovery and the maximum value will be retained. | week 6 | 
| grip strength | The grip strength will be evaluated with a dynamometer that can be squeezed very hard for 3 seconds. The measurement will be evaluated three times with 30 seconds of recovery and the maximum value will be retained. | week 18 | 
| grip strength | The grip strength will be evaluated with a dynamometer that can be squeezed very hard for 3 seconds. The measurement will be evaluated three times with 30 seconds of recovery and the maximum value will be retained. | week 30 | 
| Body composition | Body composition will be assessed by a body composition analyser in the morning on an empty stomach | week 6 | 
| Body composition | Body composition will be assessed by a body composition analyser in the morning on an empty stomach | week 18 | 
| Body composition | Body composition will be assessed by a body composition analyser in the morning on an empty stomach | week 30 | 
| Metabolic measurements | During the constant workload exercise, blood samples will be taken and metabolic measurements will be made: - Blood Lactate (mmol/L) | week 6 | 
| Metabolic measurements | During the constant workload exercise, blood samples will be taken and metabolic measurements will be made: - Blood glucose (g/L) | week 6 | 
| Hormonal measurements | During the constant workload exercise, blood samples will be taken and hormonal measurements will be made: Testosterone (ng/ml) Cortisol (ng/ml) | week 6 | 
| Metabolic measurements | During the constant workload exercise, blood samples will be taken and metabolic measurements will be made: - Blood glucose (g/L) | week 18 | 
| Metabolic measurements | During the constant workload exercise, blood samples will be taken and metabolic measurements will be made: - Blood Lactate (mmol/L) | week 18 | 
| Hormonal measurements | During the constant workload exercise, blood samples will be taken and hormonal measurements will be made: Testosterone (ng/ml) Cortisol (ng/ml) | week 18 | 
| Metabolic measurements | During the constant workload exercise, blood samples will be taken and metabolic measurements will be made: - Blood glucose (g/L) | week 30 | 
| Metabolic measurements | During the constant workload exercise, blood samples will be taken and metabolic measurements will be made: - Blood Lactate (mmol/L) | week 30 | 
| Hormonal measurements | During the constant workload exercise, blood samples will be taken and hormonal measurements will be made: Testosterone (ng/ml) Cortisol (ng/ml) | week 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Bariatric Surgery, Physical Fitness, Quality of life, Body Composition