Inspiratory Muscle TrainingInspiratoryNCT06635343
The Effect of Inspiratory Muscle Training on Respiratory Function, Balance and Functional Capacity in Trainable Mentally Handicapped Children
A study testing CPRP and Experimental Inspiratuar Muscle Training in people with Inspiratory Muscle Training, run by Kayseri University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Inspiratory Muscle Training
- What is being tested?
- CPRP and Experimental Inspiratuar Muscle Training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jun 2022to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- mental retardation with a history of hospitalization within the last month.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- CPRP, Experimental Inspiratuar Muscle Training
- Keywords
- Mental disability, breathing, inspiratory muscle training, balance
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPRPOther
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 TrainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Experimental Inspiratuar Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 8 WEEKS
Secondary outcomes (3)
Respiratory muscle strength
Respiratory muscle strength evaluated by electronic intraoral pressure measuring device at the beginning and at the end of the 8-week training. (FVC, FEV1, TCL,, PEF, FEF, FEV1%)
Measured: 8 WEEKS
Functional capacity
Functional capacity evaluated by 6-minute walking test at the beginning and at the end of the 8-week training.
Measured: 8 WEEKS
Body Balance
body balance evaluated by paediatric berg balance test at the beginning and at the end of the 8-week training.
Measured: 8 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start2 Jun 2022
- Primary completion1 Sep 2022
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inspiratory Muscle TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hanife abakay, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635343
- Sponsor's protocol ID
- KayseriU
- Acronym
- Inspiratory
- Status last verified
- Oct 2024
- First submitted
- 12 Sep 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28990891
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inspiratory Muscle Training on Respiratory Function, Balance and Functional Capacity in Trainable Mentally Handicapped Children
- ClinicalTrials.gov ID
- NCT06635343
- Acronym / sponsor ID
- Inspiratory / KayseriU
- Conditions
- Inspiratory Muscle Training
- Keywords
- Mental disability, breathing, inspiratory muscle training, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kayseri UniversityUniversity, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPRP Group | Experimental | Other: CPRPIn 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 | Experimental | Other: Experimental Inspiratuar Muscle TrainingThe experimental group underwent inspiratory muscle training (IMT) with an inspiratory muscle training device 5 days a week for 8 weeks. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- mental retardation with a history of hospitalization within the last month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPRPIn 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 Group |
| Experimental Inspiratuar Muscle TrainingIn 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 | Other | Experimental Inspiratuar Muscle Training Group |
Primary outcome
For the evaluation of functional capacity
Time frame: 8 WEEKS
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
To evaluate functional balance
Time frame: 8 WEEKS
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.
3 secondary outcomes
Respiratory muscle strength
Time frame: 8 WEEKS
Functional capacity
Time frame: 8 WEEKS
Body Balance
Time frame: 8 WEEKS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Results publication: PubMed 28990891Ulubay 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.
- Ulubay G, Köktürk N, Görek Dilektaşlı A, et al. Turkish Thoracic Society national spirometry and laboratory standards. Turk Thorac J. 2017;65:117-30.Link provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPRP and Experimental Inspiratuar Muscle Training in people with Inspiratory Muscle Training, run by Kayseri University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For the evaluation of functional capacity (time frame: 8 WEEKS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06635343, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.