Home Based Program Physical Training in Congenital Heart Disease
- Conditions
- Body CompositionCongenital Heart DiseaseFunctional CapacityQuality of Life
- Interventions
- Other: Home based exercise training
- Registration Number
- NCT06519084
- Lead Sponsor
- University of Sao Paulo General Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description TG - Training group Home based exercise training In this group, patients were instructed to perform home-based physical training. Training was carried out 4 times a week, each exercise session lasting 40 minutes. The session consisted of aerobic exercises and muscular resistance exercises, using body weight and elastic bands.
- Primary Outcome Measures
Name Time Method Improvement exercise tolerance and functional capacity (peak VO2) 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 Outcome Measures
Name Time Method Change in quality of life measurement 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.Improvement in peripheral blood flow post exercise training program Baseline to 3 months Increase forearm blood flow in mL/min/100mL
Change in body composition measurement 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.
Trial Locations
- Locations (1)
Heart Intitute
🇧🇷São Paulo, Brazil