Home Based Program Physical Training in Congenital Heart Disease

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Body Composition; Congenital Heart Disease; Functional Capacity
• Intervention / Treatment: Other: Home based exercise training

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403-900
    • Heart Intitute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TG - Training group; 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; 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.
No Intervention: CG - Control group; In this group, patients were advised to maintain their usual activities and not engage in physical training programs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life measurement	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.	Baseline to 3 months
Change in body composition measurement	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.	Baseline to 3 months
Improvement in peripheral blood flow post exercise training program	Increase forearm blood flow in mL/min/100mL	Baseline to 3 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: Home_based_CHD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No