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Completed

NCT Number: NCT04425005

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

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.

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Key information

Conditions

Bariatric Surgery Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univsersity of Sao Paulo

São Paulo, 05508-030, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home-based exercise

Other

Home-based exercise training, supervised by videoconference.

Primary outcomes

  1. Change from baseline on waist circumference at 3 months of follow-up.

    Time frame: Baseline and 3 months

    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 outcomes

  1. Change from baseline on cardiometabolic risk factor at 3 months of follow-up.

    Time frame: Baseline and 3 months

    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.

  2. Change from baseline on cardiopulmonary fitness at 3 months of follow-up.

    Time frame: Baseline and 3 months

    Cardiopulmonary fitness will be assessed by a validated two-minutes step test.

  3. Change from baseline on quality of life at 3 months of follow up.

    Time frame: Baseline and 3 months

    Will be evaluated by the SF-36 health survey questionnaire.

  4. Change from baseline on Physical activity levels at 3 months of follow up.

    Time frame: Baseline and 3 months follow-up.

    Will be evaluated by the International Physical Activity Questionnaire.

  5. Change from baseline on dietary intake at 3 months of follow up.

    Time frame: Baseline and 3 months

    Will be assessed by 24 hours food intake recall.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2020
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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