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

Primary Purpose

Bariatric Surgery, Obesity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Home-based exercise
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bariatric Surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univsersity of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Exercise training group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Change from baseline on cardiopulmonary fitness at 3 months of follow-up.
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.
Will be evaluated by the SF-36 health survey questionnaire.
Change from baseline on Physical activity levels at 3 months of follow up.
Will be evaluated by the International Physical Activity Questionnaire.
Change from baseline on dietary intake at 3 months of follow up.
Will be assessed by 24 hours food intake recall.

Full Information

First Posted
June 8, 2020
Last Updated
January 18, 2021
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04425005
Brief Title
Home-based Exercise Training During Covid-19 Pandemic in Post-bariatric
Official Title
Effect of Home-based Exercise Training Program During the Covid-19 Pandemic in Post-bariatric Patients: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 10, 2020 (Actual)
Primary Completion Date
December 7, 2020 (Actual)
Study Completion Date
December 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Title
Exercise training group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Home-based exercise
Intervention Description
Home-based exercise training, supervised by videoconference.
Primary Outcome Measure Information:
Title
Change from baseline on waist circumference at 3 months of follow-up.
Description
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.
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Change from baseline on cardiometabolic risk factor at 3 months of follow-up.
Description
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.
Time Frame
Baseline and 3 months
Title
Change from baseline on cardiopulmonary fitness at 3 months of follow-up.
Description
Cardiopulmonary fitness will be assessed by a validated two-minutes step test.
Time Frame
Baseline and 3 months
Title
Change from baseline on quality of life at 3 months of follow up.
Description
Will be evaluated by the SF-36 health survey questionnaire.
Time Frame
Baseline and 3 months
Title
Change from baseline on Physical activity levels at 3 months of follow up.
Description
Will be evaluated by the International Physical Activity Questionnaire.
Time Frame
Baseline and 3 months follow-up.
Title
Change from baseline on dietary intake at 3 months of follow up.
Description
Will be assessed by 24 hours food intake recall.
Time Frame
Baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Gualano
Organizational Affiliation
HC FMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univsersity of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05508-030
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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