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Clinical Trials/NCT06519084
NCT06519084
Completed
Not Applicable

Effect of Physical Training in Functional Capacity, Metabolic Profile, Body Composition and Quality of Life in Patients With Congenital Heart Disease

University of Sao Paulo General Hospital1 site in 1 country42 target enrollmentMarch 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
University of Sao Paulo General Hospital
Enrollment
42
Locations
1
Primary Endpoint
Improvement exercise tolerance and functional capacity (peak VO2)
Status
Completed
Last Updated
last year

Overview

Brief Summary

Previous Studies Indicate That a Substantial Proportion of the Congenital Heart Disease Patients Has Unhealthy Lifestyle Behaviors, Such as Smoking, Lack of Physical Activity, and Inadequate Dietary Patterns, Leading to the Development of Metabolic Disorders Such as Overweight/Obesity, Metabolic Syndrome, and Chronic Diseases Such as Cardiovascular Disease. Another Highly Prevalent Risk Factor in These Patients is Sedentary Behavior; These Patients Are Not Encouraged to Engage in Sports and Exercise During Childhood Due to Their Cardiac Condition, Leading to a Progressive Decrease in Physical Capacity. Studies Have Shown That Congenital Heart Disease Patients Are Not Active Enough and That a Substantial Amount of Patients is Overweight.This Study is a Randomized Controlled Trial That Investigates the Effects of the Home Based Program Physical Training, in the Exercise Capacity, Quality of Life and Body Composition.

Detailed Description

The objective of the study was to verify the effect of home physical training on improving physical capacity, body composition, quality of life, metabolic markers in patients with congenital heart disease.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
December 1, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Repaired congenital heart disease of all complexities
  • Age ≥ 18 years
  • New York Heart Association (NYHA) Class I or II
  • Able and willing to participate in a 12-week cardiac rehabilitation program

Exclusion Criteria

  • Inability to give informed consent
  • Inability to participate in an exercise training program
  • Severe musculoskeletal disorders.
  • Patient heart failure
  • Patients who perform regular physical activities.
  • Patients with Univentricular Physiology,
  • Patients severe asthma,
  • Patients with a pacemaker.
  • Patients with atrial fibrillation;
  • Exercise-induced arrhythmia and/or ischemia

Outcomes

Primary Outcomes

Improvement exercise tolerance and functional capacity (peak VO2)

Time Frame: Baseline to 3 months

Change in functional capacity will be performed by cardiopulmonary exercise test and will be expressed by Peak VO2 and Predicted Peak VO2 (%). After the training program, an increase in the peak VO2(mL/kg/min) value between 10 to 15% is expected in relation to the baseline value.

Secondary Outcomes

  • Change in quality of life measurement(Baseline to 3 months)
  • Improvement in peripheral blood flow post exercise training program(Baseline to 3 months)
  • Change in body composition measurement(Baseline to 3 months)

Study Sites (1)

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