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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
37
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.
CHR Orléans
Orléans, France
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
Time frame: 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
Time frame: 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
Time frame: Week 30
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.
Time frame: 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)
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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.
Time frame: 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.
Time frame: Week 30
Walking distance
The walking distance (meters) will be evaluated during the 6 minutes walk test
Time frame: Week 6
Walking distance
The walking distance (meters) will be evaluated during the 6 minutes walk test
Time frame: Week 18
Walking distance
The walking distance (meters) will be evaluated during the 6 minutes walk test
Time frame: Week 30
Heart rate
The heart rate (beats/min) will be evaluated during the 6 minutes walk test
Time frame: Week 6
Heart rate
The heart rate (beats/min) will be evaluated during the 6 minutes walk test
Time frame: Week 18
Heart rate
The heart rate (beats/min) will be evaluated during the 6 minutes walk test
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 30
Body composition
Body composition will be assessed by a body composition analyser in the morning on an empty stomach
Time frame: week 6
Body composition
Body composition will be assessed by a body composition analyser in the morning on an empty stomach
Time frame: week 18
Body composition
Body composition will be assessed by a body composition analyser in the morning on an empty stomach
Time frame: week 30
Metabolic measurements
During the constant workload exercise, blood samples will be taken and metabolic measurements will be made: \- Blood Lactate (mmol/L)
Time frame: week 6
Metabolic measurements
During the constant workload exercise, blood samples will be taken and metabolic measurements will be made: \- Blood glucose (g/L)
Time frame: 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)
Time frame: week 6
Metabolic measurements
During the constant workload exercise, blood samples will be taken and metabolic measurements will be made: \- Blood glucose (g/L)
Time frame: week 18
Metabolic measurements
During the constant workload exercise, blood samples will be taken and metabolic measurements will be made: \- Blood Lactate (mmol/L)
Time frame: 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)
Time frame: week 18
Metabolic measurements
During the constant workload exercise, blood samples will be taken and metabolic measurements will be made: \- Blood glucose (g/L)
Time frame: week 30
Metabolic measurements
During the constant workload exercise, blood samples will be taken and metabolic measurements will be made: \- Blood Lactate (mmol/L)
Time frame: 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)
Time frame: week 30