Scleroderma (Limited and Diffuse)NCT06684132
Respiratory Muscle Training in Scleroderma
A study testing Inspiratory muscle training and Exercise in people with Scleroderma (Limited and Diffuse), run by Firat University.
Trial summary
The aim of this study is to investigate the effects of IMT on respiratory muscle strength, pulmonary function tests, quality of life aerobic capacity, dyspnea, fatigue and physical activity level in scleroderma patients with ILD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Scleroderma (Limited and Diffuse)
- What is being tested?
- Inspiratory muscle training and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2024to 20 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old
- Patients whose medical treatment has not changed in the last three months
- Patients who volunteered to participate in the study and were cooperative
- Literate patients
- Patients followed with a diagnosis of SSc
Who cannot join
- Patients who are pregnant
- Patients with a diagnosis of malignancy
- Patients with other concomitant systemic inflammatory rheumatic diseases
- Patients with neurological, orthopedic or congenital problems that prevent physical activity
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Respiratory Muscle Training in Patients With Scleroderma With Pulmonary Involvement
The aim of this study is to investigate the effects of IMT on respiratory muscle strength, pulmonary function tests, quality of life aerobic capacity, dyspnea, fatigue and physical activity level in scleroderma patients with ILD. The study will include 30 Scleroderma + ILD patients who are under follow-up in Fırat University Rheumatology Department. Patients will be randomly divided into two groups. High intensity intermittent inspiratory muscle training (H-IMT) will be applied to the respiratory muscle training group in addition to the exercise program. Respiratory muscle strength will be assessed by maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP); aerobic capacity will be assessed by exercise test and VO2max. Dyspnea will be assessed with the Modified Medical Research Council Scale; fatigue with the Fatigue Severity Scale; quality of life with the Scleroderma Health Assessment Questionnaire; physical activity level with the International Physical Activity Scale - Short Form
Read the detailed description
Inspiratory muscle training (IMT) is performed by inspiring against an external load provided by a device. It is easy to implement, low cost and can be easily integrated into rehabilitation programs. Pulmonary rehabilitation and inspiratory muscle training have been applied as an effective method in ILD. However, there are no studies investigating the effects of IMT in individuals with ILD. The aim of this study was to investigate the effects of IMT on respiratory muscle strength, pulmonary function tests, quality of life, aerobic capacity, dyspnea, fatigue and physical activity level in scleroderma patients with ILD. The study will include 30 Scleroderma + ILD patients who are under follow-up in Fırat University Rheumatology Department. Patients will be randomly divided into two groups. High intensity intermittent inspiratory muscle training (H-IMT) will be applied to the respiratory muscle training group in addition to the exercise program. This training will be performed with Power breath (POWERbreathe Classic Light Resistance, PowerBreath, IMT Technologies Ltd, Birmingham, UK) respiratory muscle training device. In the control group, only stretching, strengthening and posture exercises will be applied as a home program. Respiratory muscle strength will be assessed by maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP); aerobic capacity will be assessed by VO2max with exercise test. dyspnea will be assessed using the Modified Medical Research Council Scale; fatigue will be assessed using the Fatigue Severity Scale; quality of life will be assessed using the Scleroderma Health Assessment Questionnaire; physical activity level will be assessed using the International Physical Activity Scale - Short Form.
- Conditions
- Scleroderma (Limited and Diffuse)
- Being tested
- Inspiratory muscle training, Exercise
- Keywords
- Scleroderma, Inspiratory muscle training, pulmonary functions
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingOther
The H-IMT will be performed in seven sets of three-minute cycles consisting of two minutes of training followed by one minute of rest in the training workload. Each session will consist of 14 minutes of loading and seven minutes of rest for a total of 21 minutes.
ExerciseOther
Stretching exercises for pectoral muscles, neck muscles and back muscles, strengthening exercises for upper extremity and back muscles and posture exercises will be applied.
| Study group | Role | What they receive |
|---|---|---|
| IMT group | Experimental | High intensity intermittent inspiratory muscle training (H-IMT) will be applied. This training will be performed with Power breath (POWERbreathe Classic Light Resistance, PowerBreath, IMT Technologies Ltd, Birmingham, UK) respiratory muscle training device. The H-IMT will be performed in seven sets of three-minute cycles consisting of two minutes of training followed by one minute of rest in the training workload. Each session will consist of 14 minutes of loading and seven minutes of rest for a total of 21 minutes. Receives: Other: Inspiratory muscle training |
| Exercise group | Other | Stretching exercises for pectoral muscles, neck muscles and back muscles, strengthening exercises for upper extremity and back muscles and posture exercises will be applied. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle strength
Respiratory muscle strength will be assessed with an intraoral pressure gauge. Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) are commonly used non-invasive methods to determine respiratory muscle strength. These are intraoral pressures measured at maximum respiration against a valve that closes the airways. When applying MIP, the patient is asked to perform maximal expiration.
Measured: up to 8 weeks
Secondary outcomes (1)
Fatigue
Fatigue will be assessed with the Fatigue Severity Scale (FSS), the Turkish validity and reliability of which was performed by Armutlu et al.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start10 Nov 2024 (estimated)
- Primary completion10 Jan 2025 (estimated)
- Study completion20 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma (Limited and Diffuse)Studies 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
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songül Bağlan Yentür, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684132
- Sponsor's protocol ID
- 2024/13-06
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Respiratory Muscle Training in Patients With Scleroderma With Pulmonary Involvement
- ClinicalTrials.gov ID
- NCT06684132
- Acronym / sponsor ID
- 2024/13-06
- Conditions
- Scleroderma (Limited and Diffuse)
- Keywords
- Scleroderma, Inspiratory muscle training, pulmonary functions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 10 Nov 2024 (estimated)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 20 Feb 2025 (estimated)
- First posted
- 12 Nov 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.
The aim of this study is to investigate the effects of IMT on respiratory muscle strength, pulmonary function tests, quality of life aerobic capacity, dyspnea, fatigue and physical activity level in scleroderma patients with ILD. The study will include 30 Scleroderma + ILD patients who are under follow-up in Fırat University Rheumatology Department. Patients will be randomly divided into two groups. High intensity intermittent inspiratory muscle training (H-IMT) will be applied to the respiratory muscle training group in addition to the exercise program. Respiratory muscle strength will be assessed by maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP); aerobic capacity will be assessed by exercise test and VO2max. Dyspnea will be assessed with the Modified Medical Research Council Scale; fatigue with the Fatigue Severity Scale; quality of life with the Scleroderma Health Assessment Questionnaire; physical activity level with the International Physical Activity Scale - Short Form
Detailed description
Inspiratory muscle training (IMT) is performed by inspiring against an external load provided by a device. It is easy to implement, low cost and can be easily integrated into rehabilitation programs. Pulmonary rehabilitation and inspiratory muscle training have been applied as an effective method in ILD. However, there are no studies investigating the effects of IMT in individuals with ILD. The aim of this study was to investigate the effects of IMT on respiratory muscle strength, pulmonary function tests, quality of life, aerobic capacity, dyspnea, fatigue and physical activity level in scleroderma patients with ILD. The study will include 30 Scleroderma + ILD patients who are under follow-up in Fırat University Rheumatology Department. Patients will be randomly divided into two groups. High intensity intermittent inspiratory muscle training (H-IMT) will be applied to the respiratory muscle training group in addition to the exercise program. This training will be performed with Power breath (POWERbreathe Classic Light Resistance, PowerBreath, IMT Technologies Ltd, Birmingham, UK) respiratory muscle training device. In the control group, only stretching, strengthening and posture exercises will be applied as a home program. Respiratory muscle strength will be assessed by maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP); aerobic capacity will be assessed by VO2max with exercise test. dyspnea will be assessed using the Modified Medical Research Council Scale; fatigue will be assessed using the Fatigue Severity Scale; quality of life will be assessed using the Scleroderma Health Assessment Questionnaire; physical activity level will be assessed using the International Physical Activity Scale - Short Form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMT group | Experimental | Other: Inspiratory muscle trainingHigh intensity intermittent inspiratory muscle training (H-IMT) will be applied. This training will be performed with Power breath (POWERbreathe Classic Light Resistance, PowerBreath, IMT Technologies Ltd, Birmingham, UK) respiratory muscle training device. The H-IMT will be performed in seven sets of three-minute cycles consisting of two minutes of training followed by one minute of rest in the training workload. Each session will consist of 14 minutes of loading and seven minutes of rest for a total of 21 minutes. |
| Exercise group | Other | Other: ExerciseStretching exercises for pectoral muscles, neck muscles and back muscles, strengthening exercises for upper extremity and back muscles and posture exercises will be applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-65 years old
- Patients whose medical treatment has not changed in the last three months
- Patients who volunteered to participate in the study and were cooperative
- Literate patients
- Patients followed with a diagnosis of SSc
Key exclusion criteria (4 listed)
- Patients who are pregnant
- Patients with a diagnosis of malignancy
- Patients with other concomitant systemic inflammatory rheumatic diseases
- Patients with neurological, orthopedic or congenital problems that prevent physical activity
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 |
|---|---|---|
| Inspiratory muscle trainingThe H-IMT will be performed in seven sets of three-minute cycles consisting of two minutes of training followed by one minute of rest in the training workload. Each session will consist of 14 minutes of loading and seven minutes of rest for a total of 21 minutes. | Other | IMT group |
| ExerciseStretching exercises for pectoral muscles, neck muscles and back muscles, strengthening exercises for upper extremity and back muscles and posture exercises will be applied. | Other | Exercise group |
Primary outcome
Respiratory muscle strength
Time frame: up to 8 weeks
Respiratory muscle strength will be assessed with an intraoral pressure gauge. Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) are commonly used non-invasive methods to determine respiratory muscle strength. These are intraoral pressures measured at maximum respiration against a valve that closes the airways. When applying MIP, the patient is asked to perform maximal expiration.
1 secondary outcome
Fatigue
Time frame: up to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training and Exercise in people with Scleroderma (Limited and Diffuse), run by Firat University.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Songul Baglan Yentur (+90 4242370000, songulbaglan23@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory muscle strength (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2024.