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

NCT06635343 | Completed

• 1 other identifier: KayseriU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Inspiratory Muscle Training

Keywords

Mental disability; breathing; inspiratory muscle training; balance

Outcome Measures

Primary Outcomes (2)

• For the evaluation of functional capacity

  The Six-Minute Walk Test (6MWT) was applied. Each subject was asked to walk as fast as possible at their own walking pace for 6 minutes in a 30-meter straight corridor. 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. If there was a risky condition (excessive fatigue, too high pulse rate to continue walking, etc.) in the children, the test was terminated and the test was repeated when the child rested. At the end of the test, the 6MWT walking distance was recorded in meters. Of the two tests applied, the longer distance value for each individual was used for statistical analysis

  8 WEEKS

• To evaluate functional balance

  the Pediatric Berg Balance Scale (PBBS) was applied, which is the version of the Berg Balance Scale (BBS) modified for children by Franjoine et al . The scale comprises 14 items including sitting balance, standing balance, sitting to standing/standing to sitting, transfers, stepping, reaching forward with outstretched arm, reaching the floor, turning, and placing foot on stool items. Each item ranked from 0 to 4. 0 shows inability to perform the instruction, while 4 shows the ability to perform without any difficulty. Maximum total score is 56. All evaluations were repeated at the end of 8 weeks for all the children in the experimental and CPRP groups.

  8 WEEKS

Secondary Outcomes (3)

• Respiratory muscle strength

  8 WEEKS

• Functional capacity

  8 WEEKS

• Body Balance

  8 WEEKS

Study Arms (2)

CPRP Group

EXPERIMENTAL

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.

Other: CPRP

Experimental Inspiratuar Muscle Training Group

EXPERIMENTAL

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

Other: Experimental Inspiratuar Muscle Training

Interventions

CPRP 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.

CPRP Group

Experimental Inspiratuar Muscle Training 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

Experimental Inspiratuar Muscle Training Group

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• mental retardation with a history of hospitalization within the last month.

Sponsors & Collaborators

• Kayseri University: lead

Study Sites (1)

Hanife Abakay

Talas, Kayseri, 38280, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 28990891 RESULT

Related Links

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

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: October 10, 2024
• Study Start: June 2, 2022
• Primary Completion: September 1, 2022
• Study Completion: May 15, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)