Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635343
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
The Effect of Inspiratory Muscle Training on Respiratory Function Balance and Functional Capacity in Trainable Mentally Handicapped Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Inspiratory Muscle Training on Respiratory Function Balance and Functional Capacity in Trainable Mentally Handicapped Children
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Inspiratory
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 250 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
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 250 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 2022365 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 tableThe study included a total of 30 children aged 8-17 years with educable mental disabilities were randomly divided into experimental n15 and CPRP groups n15 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 Downs 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
--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 Downs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None