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Hospital-Based and Home-Based Resistance Training in Adult Congenital Heart Disease

H

Hacettepe University

Status

Not yet enrolling

Conditions

Functional Capacity
Muscle Strength
Resistance Training
Congenital Heart Diseases

Treatments

Other: Home-Based Resistance Training
Other: Hospital-Based Resistance Training

Study type

Interventional

Funder types

Other

Identifiers

NCT06680973
2024/09-11

Details and patient eligibility

About

Congenital heart disease (CHD) is defined as functional or anatomical abnormalities of the heart and major intrathoracic vessels present at birth. Impaired responses to exercise in individuals with CHD reduce exercise capacity and increase long-term mortality risk. Today, the growing population of adults with congenital heart disease (ACHD) faces chronic issues stemming from congenital abnormalities, along with muscle strength loss and a decline in activities of daily living. Once the planned treatments in this project proposal are implemented and data are obtained (especially if these data support the hypotheses), the treatment protocols applied in this study and their effects will be considered alongside the current treatment plans for individuals with CHD who experience muscle strength loss and disease-related impairment. With new treatment programs, this study aims to reduce disease-related muscle strength loss, improve disease-related outcomes, and enhance quality of life.

Full description

Congenital heart disease (CHD) is defined as congenital functional or anatomical abnormalities of the heart and the major intrathoracic vessels. There are numerous physiological changes that accompany and facilitate the circulatory system's adaptation to the hemodynamic demands of exercise. In individuals with CHD, altered cardiovascular anatomy and physiology adversely affect responses to exercise in various ways and to varying degrees. Impairment in in individuals with CHD reduces exercise capacity and increases long-term mortality risk. The impairment in responses to exercise makes the prescription and progression of exercise challenging. Nowadays, the increasing lifespan of the adult congenital heart disease (ACHD) population faces not only chronic issues stemming from congenital abnormalities but also muscle strength loss and a reduction in daily living activities. Early assessment of muscle strength and exercise capacity in individuals with ACHD and the implementation of appropriate exercise training will reduce the incidence of all cause and cardiovascular disease mortality. Despite the increased disease related impact and mortality risk associated with age in individuals with CHD, the number of studies on individuals with ACHD is insufficient compared to studies conducted on children.

It has been shown that resistance exercise, similar to aerobic exercise, improves symptomatic responses and responses to exercise; and can be safely applied in individuals with CHD. In cardiovascular diseases, resistance training not only maintains and increases muscle strength and mass but also has positive physiological and clinical effects on the cardiovascular system and risk factors. There are also studies showing that resistance training improves daily living activities and quality of life. The use of different application models in cardiac rehabilitation is becoming increasingly widespread. Today, increased healthcare expenditures and economic problems have emphasized the importance of minimal equipment requirements. Minimal equipment requirements, a widely accessible patient group, and reduced transportation issues and costs highlight the importance of home-based cardiac rehabilitation.

The study is designed to be prospective, randomized, and double-blind. Participants will be divided into three groups: a hospital-based resistance training group, a home-based resistance training group, and a control group. At least 33 individuals with CHD (at least 11 individuals per group) will be included in the study. The long-term effects of the exercise will be assessed using the following: peripheral muscle strength with a manual muscle testing device, functional capacity with the six-minute walk test, daily living activities with the Glittre Daily Living Activities Test, upper extremity exercise capacity with the six minute Pegboard and Ring Test, arterial stiffness with an oscillometer-based device using the pulse wave velocity technique. Participants will undergo hospital-based resistance training in one group and home-based resistance training in the other group, twice a week for 12 weeks. No training will be provided to the control group. Assessments will be conducted twice, before and after the exercise training.

Once the planned treatments in the project proposal are implemented and data is obtained, the treatment protocols and their effects applied within the scope of the study will also be considered for individuals with CHD included in the study and for those diagnosed with CHD who experience disease-related exposure and muscle strength loss after the project. The new treatment programs aim to reduce disease-related exposure and muscle strength loss and to improve quality of life. It is planned to prepare research articles and international conference presentations from the data obtained from the project.

Enrollment

33 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of congenital heart disease
  • Aged between 18 and 45 years
  • Being informed about the study and providing written consent to participate
  • Clinical stability has been achieved in the patients
  • No changes in ongoing medication treatment that negatively affect clinical stability

Exclusion criteria

  • Having additional cardiovascular, neurological, orthopedic, or any other systemic diseases
  • Being classified as high risk (severe systolic dysfunction, moderate/severe elevated pulmonary artery pressure, significant arrhythmic burden, malignant arrhythmia, etc.)
  • Not suitable for cognitive, psychological, and mental assessments
  • Undergoing a surgery other than heart surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

33 participants in 3 patient groups

Hospital-Based Resistance Training Group
Experimental group
Description:
Participants will undergo resistance training using a weight training station and elastic equipment (elastic bands and tubes).
Treatment:
Other: Hospital-Based Resistance Training
Home-Based Resistance Training Group
Experimental group
Description:
Participants will undergo resistance training at home using elastic equipment (elastic bands and tubes).
Treatment:
Other: Home-Based Resistance Training
Control Group
No Intervention group
Description:
No training will be provided to the participants.

Trial contacts and locations

1

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Central trial contact

Ceyhun TOPCUOGLU, MSc; Melda SAGLAM, Prof. Dr.

Data sourced from clinicaltrials.gov

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