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

NCT ID: NCT04425005

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-10

Study Completion Date

2020-12-07

Brief Summary

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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

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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.

Conditions

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Bariatric Surgery Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Exercise training group

Group Type EXPERIMENTAL

Home-based exercise

Intervention Type OTHER

Home-based exercise training, supervised by videoconference.

Interventions

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Home-based exercise

Home-based exercise training, supervised by videoconference.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Bruno Gualano

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruno Gualano

Role: PRINCIPAL_INVESTIGATOR

HC FMUSP

Locations

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Univsersity of Sao Paulo

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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21056813.3.0000.0068

Identifier Type: -

Identifier Source: org_study_id

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