Bariatric Surgery Clinical Trial
— ObesityOfficial title:
Effects of Physical Training on Physical and Functional Fitness, Physical Activity Level, Endothelial Function, Hemodynamic Variables, Bone Metabolism and Quality of Life of Post-bariatric Patients: a Randomized Controlled Trial
NCT number | NCT04193397 |
Other study ID # | BARexe |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 1, 2022 |
Est. completion date | March 31, 2024 |
Verified date | April 2024 |
Source | Rio de Janeiro State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this clinical trial is to study the effects of resistance training program on physical-functional fitness, muscle mass and strength, endothelial function, blood pressure, biochemical markers of cardiovascular risk and bone metabolism, density and microstructure and quality of life of post-bariatric patients (Study 1). To compare the bone and muscle changes in post-bariatric patients by Roux-en-Y Gastric Bypass Surgery with non-bariatric controls, as well as to correlate these health indicators with surgery time and weight loss (Study 2).
Status | Completed |
Enrollment | 100 |
Est. completion date | March 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Patients subjected to Roux-en-Y gastric bypass - Aging 18 to 50-years - At least 12 months from surgery Exclusion criteria: - Smoking - Alcoholism - Gestation - Cardiovascular disease - Respiratory disease - Neurological disease - Infectious disease - Endocrine disease - Musculoskeletal impairments - Use of hormonal replacement therapy that influence bone metabolism - Use of medications that influence bone metabolism - Start some physical exercise program during the study - Excess weight loss <50% - Use drugs that interfere with weight - Revisional bariatric surgery - Regular physical exercise |
Country | Name | City | State |
---|---|---|---|
Brazil | Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University | Rio De Janeiro | Rio De Janeiro, Brazil |
Lead Sponsor | Collaborator |
---|---|
Rio de Janeiro State University |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes from baseline body composition at 6 months | Muscle mass and body mineral density will be assessed by Dual-energy X-ray Absortiometry | Baseline and 6 months of follow-up | |
Primary | Changes from baseline bone microarchitecture at 6 months | Bone microarchitecture will be assessed by High-resolution peripheral quantitative computed tomography | Baseline and 6 months of follow-up | |
Primary | Changes from baseline muscle strength at 6 months | Muscle strength will be evaluated by one repetition maximum test and handgrip strength | Baseline and 6 months of follow-up | |
Primary | Changes from baseline blood biomarkers at 6 months | Bone formation and reabsorption biomarkers will be evaluated by blood sample collection | Baseline and 6 months of follow-up | |
Primary | Changes from baseline blood biomarkers at 6 months | Metabolic profile will be evaluated by blood sample collection | Baseline and 6 months of follow-up | |
Secondary | Changes from baseline quality of life indicators at 6 months | Quality of life indicators will be evaluated by 36-Item Short-form Health Survey | Baseline and 6 months of follow-up | |
Secondary | Changes from baseline cardiovascular risk factors at 6 months | Cardiovascular risk factors will be evaluated by body mass index, waist circumference, blood pressure, triglycerides, HDL-c, LDL-c, total cholesterol, and fasting glycemia | Baseline and 6 months of follow-up | |
Secondary | Changes from baseline anthropometric markers at 6 months | Anthropometric markers will be determined by a digital scale and wall-mounted stadiometer | Baseline and 6 months of follow-up | |
Secondary | Changes from baseline hemodynamic measurement at 6 months | Blood pressure and heart rate will be assessed by a digital sphygmomanometer | Baseline and 6 months of follow-up | |
Secondary | Changes from baseline endothelial function at 6 months | Endothelial function will be evaluated by venous occlusion plethysmography and periungual videocapilaroscopy | Baseline and 6 months of follow-up |
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