Clinical trial NCT06680973: Hospital-Based and Home-Based Resistance Training in Adult Congenital Heart Disease
Official title: Comparison of the Effects of Hospital-Based and Home-Based Resistance Training in Individuals with Adult Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Congenital Heart Diseases
Resistance Training
Muscle Strength
Functional Capacity
Keywords: Congenital Heart Diseases
Resistance training
Muscle strength
Functional capacity
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial design will be employed. Block randomization will be performed using computer-assisted randomization software (https://www.graphpad.com/quickcalcs/randomize1/), and stratified randomization will be applied to ensure equal gender distribution across groups. Participants will be divided into three groups:

Hospital-based resistance training group Home-based resistance training group Control group

The individuals in the hospital-based and home-based resistance training groups will undergo a 12-week training program, with evaluations conducted twice: once before and once after the training. In the control group, no training will be provided, and evaluations will be performed twice, with a 12-week interval between assessments.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Peripheral Muscle Strength- Isotonic
timeFrame: From immediately before the treatment began to 12 weeks after the treatment.
measure: Peripheral Muscle Strength-Isometric
timeFrame: From immediately before the treatment began to 12 weeks after the treatment
measure: Hand Grip Strength
timeFrame: From immediately before the treatment began to 12 weeks after the treatment.
measure: Functional Capacity
timeFrame: From immediately before the treatment began to 12 weeks after the treatment.
measure: Activities of Daily Living (ADL)
timeFrame: From immediately before the treatment began to 12 weeks after the treatment.
measure: Upper Extremity Exercise Capacity
timeFrame: From immediately before the treatment began to 12 weeks after the treatment.
measure: Body Composition
timeFrame: From immediately before the treatment began to 12 weeks after the treatment.
measure: Arterial Stiffness
timeFrame: From immediately before the treatment began to 12 weeks after the treatment.
Secondary outcomes:
measure: Functional Mobility
timeFrame: From immediately before the treatment began to 12 weeks after the treatment.
measure: Functional Mobility with Dual Task
timeFrame: From immediately before the treatment began to 12 weeks after the treatment.
measure: Cognition
timeFrame: From immediately before the treatment began to 12 weeks after the treatment.
measure: Health-Related Quality of Life
timeFrame: From immediately before the treatment began to 12 weeks after the treatment.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
citation: Niedermeyer CDC, Shizukuishi MLY, Schaan CW, Lukrafka JL. Peripheral and respiratory muscle strength in children and adolescents with CHD: systematic review and meta-analysis. Cardiol Young. 2022 Nov;32(11):1728-1741. doi: 10.1017/S1047951122003092. Epub 2022 Oct 6.
citation: Bernier PL, Stefanescu A, Samoukovic G, Tchervenkov CI. The challenge of congenital heart disease worldwide: epidemiologic and demographic facts. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2010;13(1):26-34. doi: 10.1053/j.pcsu.2010.02.005.