Hospital-Based and Home-Based Resistance Training in Adult Congenital Heart Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorHacettepe University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Hospital-Based Resistance Training
Other interventionParticipants 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
Other interventionParticipants 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.
Treatment groups
33 Participants
are divided into 3 treatment groupsGroup A: Hospital-Based Resistance Training GroupExperimental treatment 1 intervention
Group B: Home-Based Resistance Training GroupExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
From immediately before the treatment began to 12 weeks after the treatment.2
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.
Time frame
From immediately before the treatment began to 12 weeks after the treatment3
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.
Time frame
From immediately before the treatment began to 12 weeks after the treatment.4
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.
Time frame
From immediately before the treatment began to 12 weeks after the treatment.Secondary outcomes
1
Functional Mobility
It will be evaluated using the 4-meter Walk Test. The 4-meter walk test will be conducted on a 4-meter long track, with clearly marked start and end points using cones. The patient will be asked to complete the test at their usual walking speed. The timer will start at the initial movement and stop when the end point is crossed.
Time frame
From immediately before the treatment began to 12 weeks after the treatment.2
Functional Mobility with Dual Task
It will be evaluated using the Dual-Task Timed Up and Go Test.The Dual-Task Timed Up and Go Test, individuals will be asked to stand up from a chair, walk 3 meters at a safe and normal pace, turn around, walk back, and sit down again, with the time recorded in seconds. During the test, individuals will also be asked to hold a glass of water in one hand to assess motor function, and to count backward from 100 in threes to assess cognitive function. A shorter time indicates better balance and mobility ability.
Time frame
From immediately before the treatment began to 12 weeks after the treatment.3
Cognition
It will be evaluated using the Montreal Cognitive Assessment (MoCA) test. The MoCA assesses functions such as short-term memory, visuospatial skills, executive functions, abstract thinking, verbal fluency, attention, concentration, and language. The highest possible total score on the test is 30. The normal cut off score for the test is 21 points or higher. The Turkish validity and reliability of the scale were conducted by Ozdilek et al.
Time frame
From immediately before the treatment began to 12 weeks after the treatment.4
Health-Related Quality of Life
It will be assessed using the Short Form-36 (SF-36). The SF-36 is a scale that evaluates general health perception and quality of life. It consists of a total of 8 subcategories: physical function, role limitations due to physical problems, role limitations due to emotional problems, vitality, social functioning, pain, and general health perception. The scale includes 36 items and 11 questions. Each subcategory is scored between 0 and 100. A higher score indicates a higher quality of life. The Turkish validity and reliability of the scale were conducted by Pinar et al.
Time frame
From immediately before the treatment began to 12 weeks after the treatment.Sponsors and contacts
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Source ClinicalTrials.gov
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