Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04425005
Other study ID # 21056813.3.0000.0068
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 10, 2020
Est. completion date December 7, 2020

Study information

Verified date January 2021
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date December 7, 2020
Est. primary completion date December 7, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Home-based exercise
Home-based exercise training, supervised by videoconference.

Locations

Country Name City State
Brazil Univsersity of Sao Paulo Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. Baseline and 3 months
Secondary Change from baseline on cardiopulmonary fitness at 3 months of follow-up. Cardiopulmonary fitness will be assessed by a validated two-minutes step test. Baseline and 3 months
Secondary Change from baseline on quality of life at 3 months of follow up. Will be evaluated by the SF-36 health survey questionnaire. Baseline and 3 months
Secondary Change from baseline on Physical activity levels at 3 months of follow up. Will be evaluated by the International Physical Activity Questionnaire. Baseline and 3 months follow-up.
Secondary Change from baseline on dietary intake at 3 months of follow up. Will be assessed by 24 hours food intake recall. Baseline and 3 months
See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2