Clinical trial NCT06635343: The Effect of Inspiratory Muscle Training on Respiratory Function, Balance and Functional Capacity in Trainable Mentally Handicapped Children
Official title: The Effect of Inspiratory Muscle Training on Respiratory Function, Balance and Functional Capacity in Trainable Mentally Handicapped Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inspiratory Muscle Training
Keywords: Mental disability
breathing
inspiratory muscle training
balance
Lead sponsor: Kayseri University
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study was designed according to a controlled pre-test-post-test design. Voluntary consent forms were obtained from the subjects and their parents before the study. The study was conducted in accordance with the Declaration of Helsinki and the necessary Ethics Committee approval was received from XXXXX University Clinical Research Ethics Committee (Decision No: 2022\\365). The total 30 individuals who met the inclusion criteria were allocated into two groups using a stratified block randomization procedure with opaque and sealed envelopes containing group allocation numbers obtained from a computer-generated random number table.The study included a total of 30 children aged 8-17 years with educable mental disabilities were randomly divided into experimental (n=15) and CPRP groups (n=15), who were educated at XXXXX Special Education Application Centre. The study inclusion criteria:

--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:
* defined as mental retardation with a history of hospitalization within the last month.

Detailed medical histories, gender, age, weight, height and education level of all individuals were recorded.

Eligibility criteria: 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.

Primary outcomes:
measure: For the evaluation of functional capacity
timeFrame: 8 WEEKS
measure: To evaluate functional balance
timeFrame: 8 WEEKS
Secondary outcomes:
measure: Respiratory muscle strength
timeFrame: 8 WEEKS
measure: Functional capacity
timeFrame: 8 WEEKS
measure: Body Balance
timeFrame: 8 WEEKS
Other outcomes:
Locations:
city: Talas
country: Turkey
facility: Hanife Abakay
state: Kayseri
Study officials:
References:
citation: Ulubay G, Kokturk N, Gorek Dilektasli A, Sen E, Ciftci F, Demir T, Yildiz O, Gemicioglu B, Saryal S. [Turkish Thoracic Society national spirometry and laboratory standards]. Tuberk Toraks. 2017 Jun;65(2):117-130. doi: 10.5578/tt.50748. Turkish.