Home Based Program Physical Training in Congenital Heart Disease

NCT06519084 | Completed

• 1 other identifier: Home_based_CHD
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease; Functional Capacity; Body Composition; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Improvement exercise tolerance and functional capacity (peak VO2)

  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.

  Baseline to 3 months

Secondary Outcomes (3)

• Change in quality of life measurement

  Baseline to 3 months

• Change in body composition measurement

  Baseline to 3 months

• Improvement in peripheral blood flow post exercise training program

  Baseline to 3 months

Study Arms (2)

TG - Training group

EXPERIMENTAL

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.

Other: Home based exercise training

CG - Control group

NO INTERVENTION

In this group, patients were advised to maintain their usual activities and not engage in physical training programs.

Interventions

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.

TG - Training group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Heart Intitute

São Paulo, 05403-900, Brazil

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: July 25, 2024
• Study Start: March 1, 2020
• Primary Completion: March 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 25, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)