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

Not Applicable

Completed

• Conditions: Obesity; Bariatric Surgery
• Interventions: Other: Home-based exercise

• Registration Number: NCT04425005
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-05-10
• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Primary Completion: 2020-12-07
• Study Completion: 2020-12-07
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-18
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise training group	Home-based exercise	-

Primary Outcome Measures

Name	Time	Method
Change from baseline on waist circumference at 3 months of follow-up.	Baseline and 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline on cardiometabolic risk factor at 3 months of follow-up.	Baseline and 3 months	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.
Change from baseline on cardiopulmonary fitness at 3 months of follow-up.	Baseline and 3 months	Cardiopulmonary fitness will be assessed by a validated two-minutes step test.
Change from baseline on quality of life at 3 months of follow up.	Baseline and 3 months	Will be evaluated by the SF-36 health survey questionnaire.
Change from baseline on Physical activity levels at 3 months of follow up.	Baseline and 3 months follow-up.	Will be evaluated by the International Physical Activity Questionnaire.
Change from baseline on dietary intake at 3 months of follow up.	Baseline and 3 months	Will be assessed by 24 hours food intake recall.

Trial Locations

Locations (1)

Univsersity of Sao Paulo; 🇧🇷 Sao Paulo, Brazil