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Clinical Trials/NCT04425005
NCT04425005
Completed
Not Applicable

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

University of Sao Paulo1 site in 1 country55 target enrollmentMay 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bariatric Surgery
Sponsor
University of Sao Paulo
Enrollment
55
Locations
1
Primary Endpoint
Change from baseline on waist circumference at 3 months of follow-up.
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 10, 2020
End Date
December 7, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bruno Gualano

Professor

University of Sao Paulo

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change from baseline on waist circumference at 3 months of follow-up.

Time Frame: 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 Outcomes

  • Change from baseline on cardiometabolic risk factor at 3 months of follow-up.(Baseline and 3 months)
  • Change from baseline on cardiopulmonary fitness at 3 months of follow-up.(Baseline and 3 months)
  • Change from baseline on quality of life at 3 months of follow up.(Baseline and 3 months)
  • Change from baseline on Physical activity levels at 3 months of follow up.(Baseline and 3 months follow-up.)
  • Change from baseline on dietary intake at 3 months of follow up.(Baseline and 3 months)

Study Sites (1)

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