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

NCT06680973 | Not Yet Recruiting DMC

• 1 other identifier: 2024/09-11
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Congenital Heart Diseases; Resistance training; Muscle strength; Functional capacity

Outcome Measures

Primary Outcomes (8)

• Peripheral Muscle Strength- Isotonic

  Isotonic strength will be assessed three times on both the right and left sides. Isotonic strength will be evaluated using the 1-repetition maximum technique with a weight training station for knee extension, pull down, chest press, and pec deck functions.

  From immediately before the treatment began to 12 weeks after the treatment.

• Peripheral Muscle Strength-Isometric

  Isometric strength will be assessed three times on both the right and left sides. Isometric strength will be assessed using a manual muscle testing device (K-Force Push, France) for knee extension, shoulder and hip abduction, flexion, and extension, as well as elbow flexion and extension.

  From immediately before the treatment began to 12 weeks after the treatment

• Hand Grip Strength

  Maximum isometric hand grip strength will be assessed using a digital hand dynamometer (K-Force Grip, France). During the test, individuals will be seated upright in a chair with their elbow positioned at a 90° flexion. Three measurements will be taken for both the right and left hands, and the highest value will be recorded. A 20-second rest period will be allowed between measurements.

  From immediately before the treatment began to 12 weeks after the treatment.

• Functional Capacity

  Functional capacity will be assessed using the 6-minute walk test (6 MWT). For the 6 MWT, the start and end points of a 30-meter corridor will be marked, and participants will be instructed to walk the distance at their maximum walking speed without running for 6 minutes. Before and after the test, fatigue levels will be recorded using the Borg scale, along with measurements of blood pressure, heart rate, and oxygen saturation. The 6 MWT is considered an easily applicable, widely used, and safe submaximal exercise test for individuals with congenital heart disease.

  From immediately before the treatment began to 12 weeks after the treatment.

• Activities of Daily Living (ADL)

  The Glittre Activities of Daily Living (ADL) Test will be used to assess activities of daily living and functional status. Participants will begin the test in a seated position, wearing backpacks weighing 5 kg for men and 2.5 kg for women. The test will take place over a 10-meter distance between a chair and a shelf, with a two-step staircase located in the middle. Participants will be asked to walk as quickly as possible to the steps, climb up and down, pick up a 1-kilogram bottle from the shelf, first place it in the center, then lower it, return it to the center, and finally place it at the top. They will then return, pass the steps, sit back in the chair, and stand up again to complete one round. The total time taken to complete five rounds will be recorded in minutes.

  From immediately before the treatment began to 12 weeks after the treatment.

• Upper Extremity Exercise Capacity

  The Six-Minute Pegboard and Ring Test (6-PBRT) will be used to assess upper extremity exercise capacity. For the test, a board will be used with six holes spaced 10 cm apart on a horizontal plane, and six additional holes will be positioned 20 cm below them in alignment. Four wooden rods, easily inserted and removed from the holes, will be placed, and 20 rings that fit the rods will be used. The placement of the rods will be based on the individual's shoulder width measurement. Participants will be instructed to place the rings with both hands, first from the bottom to the top, then from the top to the bottom, over the course of six minutes. Two rings that are removed and replaced simultaneously will be counted as one set. At the end of the six minutes, the total number of rings placed will be recorded in terms of the number of completed rings.

  From immediately before the treatment began to 12 weeks after the treatment.

• Body Composition

  The lean body mass percentage of the individual will be determined by Bioelectrical Impedance Analysis. The measurement will be made by the individual standing on the device with bare feet and waiting. If the lean body mass percentage values are in the normal range, the body composition is normal; lean body mass percentage low values indicate deterioration of body composition.

  From immediately before the treatment began to 12 weeks after the treatment.

• Arterial Stiffness

  Arterial stiffness will be assessed non-invasively using the Mobil-O-GRAPH (TG) device (I.E.M., Stolberg, Germany), an oscillometer-based device, with the pulse wave velocity (PWV) technique. During the measurement, the patient will sit in an upright position on a chair and remain still in silence. The cuff of the device will be placed on the individual's right arm, with its lower edge positioned above the elbow. The individual's arm will be supported and fixed with a pillow to align with the level of the heart.

  From immediately before the treatment began to 12 weeks after the treatment.

Secondary Outcomes (4)

• Functional Mobility

  From immediately before the treatment began to 12 weeks after the treatment.

• Functional Mobility with Dual Task

  From immediately before the treatment began to 12 weeks after the treatment.

• Cognition

  From immediately before the treatment began to 12 weeks after the treatment.

• Health-Related Quality of Life

  From immediately before the treatment began to 12 weeks after the treatment.

Study Arms (3)

Hospital-Based Resistance Training Group

EXPERIMENTAL

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

Other: Hospital-Based Resistance Training

Home-Based Resistance Training Group

EXPERIMENTAL

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

Other: Home-Based Resistance Training

Control Group

NO INTERVENTION

No training will be provided to the participants.

Interventions

Hospital-Based Resistance Training 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.

Hospital-Based Resistance Training Group

Home-Based Resistance Training 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.

Home-Based Resistance Training Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 36200343 BACKGROUND

• 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.

  PMID: 20307858 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ceyhun TOPCUOGLU, MSc

CONTACT

+90 535 653 51 37; ceyhuntopcuoglu1@gmail.com

Melda SAGLAM, Prof. Dr.

CONTACT

+905326374279; ptmelda@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 8, 2024
• Study Start: January 5, 2025
• Primary Completion: September 5, 2025
• Study Completion: November 5, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)