Body Composition, Congenital Heart Disease, Functional Capacity, Quality of Life
Conditions
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.
Interventions
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.
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Improvement in peripheral blood flow post exercise training program | Baseline to 3 months | Increase forearm blood flow in mL/min/100mL |
Countries
Brazil
Outcome results
None listed