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
1 other identifier
interventional
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2020
CompletedFirst Submitted
Initial submission to the registry
June 8, 2020
CompletedFirst Posted
Study publicly available on registry
June 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2020
CompletedJanuary 22, 2021
January 1, 2021
7 months
June 8, 2020
January 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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 Arms (2)
Control group
NO INTERVENTIONExercise training group
EXPERIMENTALInterventions
Home-based exercise training, supervised by videoconference.
Eligibility Criteria
You may qualify if:
- Men and women submitted to bariatric surgery in the last 12 months.
- Not engaged in regular exercise training programs.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Univsersity of Sao Paulo
São Paulo, 05508-030, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruno Gualano
HC FMUSP
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 8, 2020
First Posted
June 11, 2020
Study Start
May 10, 2020
Primary Completion
December 7, 2020
Study Completion
December 7, 2020
Last Updated
January 22, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share