Obesity Clinical Trial
Official title:
Effect of Home-based Exercise Training Program During the Covid-19 Pandemic in Post-bariatric Patients: A Randomized Controlled Trial
Verified date | January 2021 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to assess the effect of a home-based exercise training during social isolation due to covid-19 pandemic in patients who undertook bariatric surgery.
Status | Completed |
Enrollment | 55 |
Est. completion date | December 7, 2020 |
Est. primary completion date | December 7, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Men and women submitted to bariatric surgery in the last 12 months. - Not engaged in regular exercise training programs. Exclusion Criteria: - Patients with >12 months of post-operatory period. - Patients with diagnosed mental disorders. - Patients with physical limitations or not allowed by the physician to exercise. - Patients infected with Covid-19 at the time of data collection. |
Country | Name | City | State |
---|---|---|---|
Brazil | Univsersity of Sao Paulo | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline on waist circumference at 3 months of follow-up. | Waist circumference will be measured using a steel measuring tape to the nearest 0.1cm at the high point of the iliac crest at minimal respiration. | Baseline and 3 months | |
Secondary | Change from baseline on cardiometabolic risk factor at 3 months of follow-up. | Cardiometabolic risk will be calculated using mean blood pressure, fasting triglycerides, HDL, waist circumference and fasting glucose. These outocomes will be presented separately as well. | Baseline and 3 months | |
Secondary | Change from baseline on cardiopulmonary fitness at 3 months of follow-up. | Cardiopulmonary fitness will be assessed by a validated two-minutes step test. | Baseline and 3 months | |
Secondary | Change from baseline on quality of life at 3 months of follow up. | Will be evaluated by the SF-36 health survey questionnaire. | Baseline and 3 months | |
Secondary | Change from baseline on Physical activity levels at 3 months of follow up. | Will be evaluated by the International Physical Activity Questionnaire. | Baseline and 3 months follow-up. | |
Secondary | Change from baseline on dietary intake at 3 months of follow up. | Will be assessed by 24 hours food intake recall. | Baseline and 3 months |
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