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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04425005
Enrollment
55
Registered
2020-06-11
Start date
2020-05-10
Completion date
2020-12-07
Last updated
2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery, Obesity

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.

Interventions

OTHERHome-based exercise

Home-based exercise training, supervised by videoconference.

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline on waist circumference at 3 months of follow-up.Baseline and 3 monthsWaist 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

MeasureTime frameDescription
Change from baseline on cardiometabolic risk factor at 3 months of follow-up.Baseline and 3 monthsCardiometabolic 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 monthsCardiopulmonary 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 monthsWill 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 monthsWill be assessed by 24 hours food intake recall.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026