Home-based Exercise Training During Covid-19 Pandemic in Post-bariatric

Study Overview
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Brief Summary
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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.

Detailed Description
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Eligible patients will be invited to participate in the study by phone call. The research team will visit the included patients. All patients giving the written consent will perform the following tests before being randomly allocated into exercise training or control: 1) blood pressure; 2) anthropometric measures; 3) blood sampling; 4) handgrip test; 5) sit and stand test; 6) exercise capacity; 7) nutritional recalls and 8) health-related questionnaires. Patients will be randomized in a 1:1 ratio to control group (will receive information to keep active and eating healthy) or exercise training group (will receive a telemonitored exercise program through video conference, three times a week, during 3 months). Following 3 months of intervention, the outocomes will be re-assessed.

Official Title
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Effect of Home-based Exercise Training Program During the Covid-19 Pandemic in Post-bariatric Patients: A Randomized Controlled Trial

Conditions
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Bariatric Surgery, Obesity

Intervention / Treatment
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* Other: Home-based exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br> | |
| Experimental: Exercise training group<br> | Other: Home-based exercise<br>* Home-based exercise training, supervised by videoconference.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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. | 
| 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 |