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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04425005
• Other study ID #: 21056813.3.0000.0068
• Status: Completed
• Phase: N/A
• Start date: May 10, 2020
• Est. completion date: December 7, 2020

Study information

• Verified date: January 2021
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Bariatric Surgery
• Obesity

Intervention

Other:
• Home-based exercise
Home-based exercise training, supervised by videoconference.

Locations

Country	Name	City	State
Brazil	Univsersity of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

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