CompletedNot Applicable

The Effect of Inspiratory Muscle Training on Respiratory Function, Balance and Functional Capacity in Trainable Mentally Handicapped Children

Turkey (Türkiye)30 participantsStarted 2022-06-02

Plain-language summary

Background: The aim of this study was to examine the effect of inspiratory muscle training on respiratory functions, balance and functional capacity in trainable mentally disabled individuals. Methods: Within the scope of the study, 30 children, aged between 8 and 17 years, diagnosed with educable mental disabilities, were randomly divided into experimental and conventional physiotherapy rehabilitation program (CPRP) groups. Before and after the test, blood pressure, respiratory frequency, pulse oximetry heart rate and arterial oxygen saturation (SpO2) values, and Modified Borg scores for fatigue and dyspnea detection were recorded. Body composition analysis, respiratory function test, and 6-minute walk test (6MWT) were performed on all individuals. The experimental group underwent inspiratory muscle training (IMT) with an inspiratory muscle training device 5 days a week for 8 weeks. The CPRP group was given a chest physiotherapy program that included thoracic expansion exercises, postural drainage, cough improvement techniques and physical activity recommendations, to be applied once a day, 5 days a week, for 8 weeks. At the end of eight weeks, the evaluations were repeated. Data were analyzed using SPSS vn. 25.0 software. The Paired Samples t-test was used to determine within-group differences, and Two-way ANOVA was applied to repeated measures to compare time and group effects.

Who can participate

Age range

8 Years – 17 Years

Sex

ALL

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Inclusion Criteria: * The study inclusion criteria were defined as a primary diagnosis of educable mental retardation, * age range between 8-17 years, * not having a condition that prevents exercise, autism defined as educable mental retardation in children according to the diagnosis made by the Guidance and Research Centers, Down's syndrome, or epilepsy with seizures. * There were no additional disabilities such as hearing impairment or orthopedic disability. Exclusion Criteria: * mental retardation with a history of hospitalization within the last month.

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
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4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

For the evaluation of functional capacity

Timeframe: 8 WEEKS

To evaluate functional balance

Timeframe: 8 WEEKS

Trial details

NCT IDNCT06635343

SponsorKayseri University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-01

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