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

NCT ID: NCT06680973

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-05
• Study Completion Date: 2025-11-05

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.

Conditions

Congenital Heart Diseases; Resistance Training; Muscle Strength; Functional Capacity

Study Design

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

Study Groups

Hospital-Based Resistance Training Group

Participants will undergo resistance training using a weight training station and elastic equipment (elastic bands and tubes).

Group Type: EXPERIMENTAL

Hospital-Based Resistance Training

Intervention Type: OTHER

Participants will undergo resistance training using a weight training station and elastic equipment (elastic bands and tubes).

The intensity of the resistance training with the weight training station will be determined based on 1 Repetition Maximum (1RM). Resistance training with the weight training station will be conducted at 30-70% of the 1RM intensity and will include the following exercises: leg extension, pull down, chest press, and pec deck.

The intensity of resistance training using elastic equipment will be determined according to the individual's perceived exertion. Resistance training with elastic equipment will be performed at an intensity of 12-14 on the Borg Scale (moderate to somewhat hard) for movements involving hip flexion, extension, abduction, and adduction.

The resistance training regimen will consist of 8-12 repetitions, 2-3 sets, with at least 1 minute of rest between sets, twice a week for 12 weeks.

Home-Based Resistance Training Group

Participants will undergo resistance training at home using elastic equipment (elastic bands and tubes).

Group Type: EXPERIMENTAL

Home-Based Resistance Training

Intervention Type: OTHER

Participants will undergo resistance training at home using elastic equipment (elastic bands and tubes). The intensity of the resistance training will be determined based on the individual's perceived exertion. The training will be conducted at an intensity of 12-14 on the Borg Scale (moderate to somewhat hard), with 8-12 repetitions, 2-3 sets, and a rest period of at least 1 minute between sets, twice a week for 12 weeks. Progression in training intensity will be achieved by increasing the weight once the perceived exertion, as measured on the Modified Borg Scale, falls below 3 (moderate) after completing 20 repetitions.

Resistance training will include exercises such as leg extension, pull down, chest press, pec deck, and movements involving hip flexion, extension, abduction, and adduction. To ensure individuals perform exercises correctly, follow-up will be conducted through online meetings every two weeks. These meetings will not be recorded.

Control Group

No training will be provided to the participants.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hospital-Based Resistance Training

Participants will undergo resistance training using a weight training station and elastic equipment (elastic bands and tubes).

The intensity of the resistance training with the weight training station will be determined based on 1 Repetition Maximum (1RM). Resistance training with the weight training station will be conducted at 30-70% of the 1RM intensity and will include the following exercises: leg extension, pull down, chest press, and pec deck.

The intensity of resistance training using elastic equipment will be determined according to the individual's perceived exertion. Resistance training with elastic equipment will be performed at an intensity of 12-14 on the Borg Scale (moderate to somewhat hard) for movements involving hip flexion, extension, abduction, and adduction.

The resistance training regimen will consist of 8-12 repetitions, 2-3 sets, with at least 1 minute of rest between sets, twice a week for 12 weeks.

Intervention Type: OTHER

Home-Based Resistance Training

Participants will undergo resistance training at home using elastic equipment (elastic bands and tubes). The intensity of the resistance training will be determined based on the individual's perceived exertion. The training will be conducted at an intensity of 12-14 on the Borg Scale (moderate to somewhat hard), with 8-12 repetitions, 2-3 sets, and a rest period of at least 1 minute between sets, twice a week for 12 weeks. Progression in training intensity will be achieved by increasing the weight once the perceived exertion, as measured on the Modified Borg Scale, falls below 3 (moderate) after completing 20 repetitions.

Resistance training will include exercises such as leg extension, pull down, chest press, pec deck, and movements involving hip flexion, extension, abduction, and adduction. To ensure individuals perform exercises correctly, follow-up will be conducted through online meetings every two weeks. These meetings will not be recorded.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Ceyhun Topcuoglu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hacettepe University

Ankara, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Ceyhun TOPCUOGLU, MSc

Role: CONTACT

ceyhuntopcuoglu1@gmail.com

+90 535 653 51 37

Melda SAGLAM, Prof. Dr.

Role: CONTACT

ptmelda@gmail.com

+905326374279

Facility Contacts

Ceyhun TOPCUOGLU, MSc

Role: primary

ceyhuntopcuoglu1@gmail.com

+90 535 653 51 37

References

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.

Reference Type: BACKGROUND

PMID: 36200343 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20307858 (View on PubMed)

Other Identifiers

2024/09-11

Identifier Type: -

Identifier Source: org_study_id