Home Based Program Physical Training in Congenital Heart Disease

NCT ID: NCT06519084

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2023-12-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Home based exercise training

Intervention Type: 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.

CG - Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Heart Intitute

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

Home_based_CHD

Identifier Type: -

Identifier Source: org_study_id