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The Effect of Telerehabilitation Exercises in Children With Congenital Heart Disease

ConditionsCongenital Heart DiseaseTelerehabilitationFunctional Inspiratory Muscle Training
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorIzmir Democracy University

About this trial

This study aims to investigate the effects of functional inspiratory muscle training on physical performance and quality of life in pediatric patients with congenital heart disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Having been diagnosed with CHD,

Being between 8 and 18 years of age,

Being in stage I, II, or III according to the New York Heart Association (NYHA) classification,

Having a stable clinical condition,

Disqualifiers

Having a history of any orthopedic or neurological disease that could interfere with the tests and exercises to be performed,

Having a history of any mental or psychological disease that could interfere with the tests and exercises to be performed,

Having any infection that could interfere with the tests and exercises to be performed,

Having undergone cardiac surgery within the last 6 months,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inspiratory Muscle Training

    Other intervention

    Moderate-intensity basic inspiratory muscle training will be provided using a threshold pressure loading device (POWERBreathe) for the first four weeks, starting at 30% of MIP and gradually increasing to 50% depending on the participant's tolerance. The training will be conducted twice daily, 15 minutes in the morning and 15 minutes in the evening, for a total of 30 minutes. With the device, the patient will perform 5-10 deep breathing cycles, then remove the device and perform 3-5 calm breaths to control their breathing. At the end of each day, the physiotherapist will communicate with the patients to assess their progress in the exercise and record it in the exercise log.

  • Functional Inspiratory Muscle Training

    Other intervention

    Following basic IMT, simultaneous exercises (wall plank, wall lateral bridge, wall bridge, shoulder flexion/abduction, elbow flexion, trunk rotation, squat-stand, standing leg raise, walking) will be performed for 4 weeks. Abdominal muscle activation will be taught at the beginning of the training, and functional exercises, paying attention to abdominal stabilization, will continue throughout the training sessions. Moderate intensity IMT will be applied, starting from 30% of the MIP and increasing up to 50% depending on the participant's tolerance. While using the device, the patient will take 5-10 deep breaths and simultaneously perform the functional exercises in sequence, each with 5-10 repetitions/sets (1-3 sets per day). Then, they will remove the device from their mouth and practice breath control by taking 3-5 calm breaths. Exercises that the patient cannot perform will be recorded.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: İntervention groupExperimental treatment 2 interventions
Group B: Controlled groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Inspiratory Muscle Strength

Inspiratory muscle strength will be assessed with a spirometer. The highest value for inspiratory pressure will be recorded.

Time frame
Baseline and after 8-week
2

Expiratory Muscle Strength

Expiratory muscle strength will be assessed with a spirometer. The highest value for expiratory pressure will be recorded.

Time frame
Baseline and after 8-week

Secondary outcomes

1

Quality of Life Score

The Pediatric Quality of Life Inventory 3.0 Cardiac Module will be assessed using Turkish versions of the 8-12 and 13-18 year old child and parent forms. A minimum score of 0 and a maximum score of 100 can be obtained on the scale; a higher score indicates a higher quality of life.

Time frame
Baseline and after 8-week
2

Exercise Capacity measurement

Maximal exercise capacity will be assessed using the Incremental Shuttle Walk Test. The number of shuttles completed after the test will be recorded.

Time frame
Baseline and after 8-week
3

Measurement of Functional Capacity

Functional capacity will be assessed using the 1-minute sit-to-stand test, and the number of sit-to-stand repetitions performed in one minute will be recorded.

Time frame
Baseline and after 8-week
4

Grip strength measurement

Grip strength will be measured using a standard, adjustable, and portable hydraulic hand dynamometer.

Time frame
Baseline and after 8-week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Izmir Democracy University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: