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

NCT ID: NCT06635343

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-02
• Study Completion Date: 2024-05-15

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.

Conditions

Inspiratory Muscle Training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CPRP Group

In the CPRP group, a chest physiotherapy program was given by the physiotherapist 5 days a week, for 8 weeks, including respiratory control, diaphragmatic breathing, thoracic expansion exercises, and physical activity recommendations, to be applied once a day.

Group Type: EXPERIMENTAL

CPRP

Intervention Type: OTHER

In the CPRP group, a chest physiotherapy program was given by the physiotherapist 5 days a week, for 8 weeks, including respiratory control, diaphragmatic breathing, thoracic expansion exercises, and physical activity recommendations, to be applied once a day.

Experimental Inspiratuar Muscle Training Group

The experimental group underwent inspiratory muscle training (IMT) with an inspiratory muscle training device 5 days a week for 8 weeks.

Group Type: EXPERIMENTAL

Experimental Inspiratuar Muscle Training

Intervention Type: OTHER

In the experimental group inspiratory muscle training was applied. Children in the experimental group started inspiratory muscle training at 30% of the measured intra-oral maximum inspiratory pressure (MIP) value with 30x2 breaths (1 minute rest between repetitions) for 5 days a week for 8 weeks. The training was carried out with MIP every week. The training was continued for a total of 8 weeks with 30% of the new value by re-measuring the MIP value every week The value was measured again and continued at 30% of the new value for a total of 8 weeks. During each inspiratory muscle training session, oxygen saturation data from the index finger were monitored with a pulse oximeter to prevent individuals from experiencing hypoxia

Interventions

CPRP

In the CPRP group, a chest physiotherapy program was given by the physiotherapist 5 days a week, for 8 weeks, including respiratory control, diaphragmatic breathing, thoracic expansion exercises, and physical activity recommendations, to be applied once a day.

Intervention Type: OTHER

Experimental Inspiratuar Muscle Training

In the experimental group inspiratory muscle training was applied. Children in the experimental group started inspiratory muscle training at 30% of the measured intra-oral maximum inspiratory pressure (MIP) value with 30x2 breaths (1 minute rest between repetitions) for 5 days a week for 8 weeks. The training was carried out with MIP every week. The training was continued for a total of 8 weeks with 30% of the new value by re-measuring the MIP value every week The value was measured again and continued at 30% of the new value for a total of 8 weeks. During each inspiratory muscle training session, oxygen saturation data from the index finger were monitored with a pulse oximeter to prevent individuals from experiencing hypoxia

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kayseri University

OTHER

Sponsor Role: lead

Responsible Party

hanife abakay

Assoc Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hanife Abakay

Talas, Kayseri, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 28990891 (View on PubMed)

Study Documents

Document Type: Study Protocol

View Document

Related Links

https://pubmed.ncbi.nlm.nih.gov/28990891/

Ulubay G, Köktürk N, Görek Dilektaşlı A, et al. Turkish Thoracic Society national spirometry and laboratory standards. Turk Thorac J. 2017;65:117-30.

https://pubmed.ncbi.nlm.nih.gov/28990891/

Related Info

Other Identifiers

KayseriU

Identifier Type: -

Identifier Source: org_study_id