Effects of Exercise in Bariatric Patients: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Sao Paulo
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- profile of cytokines
Study Overview
Brief Summary
Bariatric surgery may attenuate insulin resistance and low-grade inflammation in obese subjects. This trial aims to test whether exercise training can add to the benefits of bariatric surgery on insulin sensitivity and inflammation. In addition, this study aims to investigate whether exercise training can counteract bone loss induced by bariatric surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •body mass index ≥ 35 kg/m2
- •not engaged in physical activity programs
- •without any physical limitation that could preclude exercise participation
Exclusion Criteria
- •body mass index < 35 kg/m2
- •regular participation in physical activities programs
- •cancer or any other disease that could limit participation in exercise
Arms & Interventions
control
Subjects will undergo bariatric surgery and no exercise training will be prescribed.
exercise training
Subjects will undergo bariatric surgery and exercise training will be prescribed.
Intervention: Exercise training (Other)
Outcomes
Primary Outcomes
profile of cytokines
Time Frame: 6 months
insulin sensitivity as assessed by surrogates of insulin sensitivity
Time Frame: 6 months
body composition as assessed by densitometry (DEXA)
Time Frame: 6 months
bone mass, lean mass and fat mass
Secondary Outcomes
- muscle function as assessed by a battery of tests(6 months)
- depression and anxiety as assessed by questionnaires (composite)(6 months)
- quality of life as assessed by questionnaires (composite)(6 months)
- risk of cardiovascular events as assessed by questionnaires (composite)(6 months)
- physical activity level as assessed by accelerometry(6 months)
- aerobic conditioning as assessed by a cardiopulmonary test.(6 months)
Investigators
Bruno Gualano
Professor
University of Sao Paulo