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Completed

NCT Number: NCT05050968

Physical Activity and Bariatric Surgery

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.

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Key information

Conditions

Bariatric Surgery Candidate Behavior Motor Activity

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHR Orléans

Orléans, 45067, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Other

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.

Primary outcomes

  1. Maximum oxygen consumption (VO2 max)

    Time frame: Week 6

    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

  2. Maximum oxygen consumption (VO2 max)

    Time frame: Week 18

    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

  3. Maximum oxygen consumption (VO2 max)

    Time frame: Week 30

    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

Secondary outcomes

  1. 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)

    Time frame: Week 6

    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.

  2. 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)

    Time frame: Week 18

    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.

  3. 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)

    Time frame: Week 30

    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.

  4. Walking distance

    Time frame: Week 6

    The walking distance (meters) will be evaluated during the 6 minutes walk test

  5. Walking distance

    Time frame: Week 18

    The walking distance (meters) will be evaluated during the 6 minutes walk test

  6. Walking distance

    Time frame: Week 30

    The walking distance (meters) will be evaluated during the 6 minutes walk test

  7. Heart rate

    Time frame: Week 6

    The heart rate (beats/min) will be evaluated during the 6 minutes walk test

  8. Heart rate

    Time frame: Week 18

    The heart rate (beats/min) will be evaluated during the 6 minutes walk test

  9. Heart rate

    Time frame: Week 30

    The heart rate (beats/min) will be evaluated during the 6 minutes walk test

  10. Perception of the effort

    Time frame: Week 6

    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.

  11. Perception of the effort

    Time frame: Week 18

    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.

  12. Perception of the effort

    Time frame: Week 36

    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.

  13. Maximum voluntary force of the quadriceps

    Time frame: week 6

    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.

  14. Maximum voluntary force of the quadriceps

    Time frame: week 18

    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.

  15. Maximum voluntary force of the quadriceps

    Time frame: week 30

    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.

  16. grip strength

    Time frame: week 6

    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.

  17. grip strength

    Time frame: week 18

    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.

  18. grip strength

    Time frame: week 30

    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.

  19. Body composition

    Time frame: week 6

    Body composition will be assessed by a body composition analyser in the morning on an empty stomach

  20. Body composition

    Time frame: week 18

    Body composition will be assessed by a body composition analyser in the morning on an empty stomach

  21. Body composition

    Time frame: week 30

    Body composition will be assessed by a body composition analyser in the morning on an empty stomach

  22. Metabolic measurements

    Time frame: week 6

    During the constant workload exercise, blood samples will be taken and metabolic measurements will be made:

    • Blood Lactate (mmol/L)

  23. Metabolic measurements

    Time frame: week 6

    During the constant workload exercise, blood samples will be taken and metabolic measurements will be made:

    • Blood glucose (g/L)

  24. Hormonal measurements

    Time frame: week 6

    During the constant workload exercise, blood samples will be taken and hormonal measurements will be made:

    • Testosterone (ng/ml)
    • Cortisol (ng/ml)

  25. Metabolic measurements

    Time frame: week 18

    During the constant workload exercise, blood samples will be taken and metabolic measurements will be made:

    • Blood glucose (g/L)

  26. Metabolic measurements

    Time frame: week 18

    During the constant workload exercise, blood samples will be taken and metabolic measurements will be made:

    • Blood Lactate (mmol/L)

  27. Hormonal measurements

    Time frame: week 18

    During the constant workload exercise, blood samples will be taken and hormonal measurements will be made:

    • Testosterone (ng/ml)
    • Cortisol (ng/ml)

  28. Metabolic measurements

    Time frame: week 30

    During the constant workload exercise, blood samples will be taken and metabolic measurements will be made:

    • Blood glucose (g/L)

  29. Metabolic measurements

    Time frame: week 30

    During the constant workload exercise, blood samples will be taken and metabolic measurements will be made:

    • Blood Lactate (mmol/L)

  30. Hormonal measurements

    Time frame: week 30

    During the constant workload exercise, blood samples will be taken and hormonal measurements will be made:

    • Testosterone (ng/ml)
    • Cortisol (ng/ml)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

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

Acronym: ACTIBARIA

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 21, 2021
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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