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Completed

NCT Number: NCT06519084

Home Based Program Physical Training in Congenital Heart Disease

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.

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Key information

Conditions

Congenital Heart Disease Body Composition Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Functional Capacity Heart Defects, Congenital Heart Diseases Quality of Life

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Intitute

São Paulo, 05403-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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
  • Cyanosis at rest
  • Severe intellectual disability

Treatment and study plan

Home based exercise training

Other

Intervention: home based physical exercise performed 4 times a week, each session lasting 40 minutes each. Aerobic and muscular resistance exercises, using body weight and elastic bands.

The sessions were proposed through video classes, in total 12 video classes during the 12 weeks of physical training. Patients monitored their heart rate during exercise and wrote it down on spreadsheets that were monitored weekly.

Primary outcomes

  1. 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

  1. Change in quality of life measurement

    Time frame: Baseline to 3 months

    Changes in quality of life will be measure by Short Form 36 questionnaire by 8 domains: Physical functioning, Physical role functioning, body pain, general health, vitality, social functioning, emotional role functioning, mental health.

    The quality of life rating for each domain is typically measured on a scale of 0 to 100, where a score close to 100 indicates a higher or higher quality of life, while a score close to 0 suggests a lower or poorer quality of life.

  2. Change in body composition measurement

    Time frame: Baseline to 3 months

    The body composition were assessment by the bioimpedance analyses in the baseline and After the home based training program with duration 12 weeks ou usual routine.

  3. Improvement in peripheral blood flow post exercise training program

    Time frame: Baseline to 3 months

    Increase forearm blood flow in mL/min/100mL

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 25, 2024
Registry last updated
Jul 25, 2024

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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