Inflammatory MyopathiesNCT07274267
Inspiratory Muscle Training in Patients With Inflammatory Myopathy
A study testing Inspiratory Muscle Training (IMT) in people with Inflammatory Myopathies, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
Trial summary
Inflammatory myopathies are rare autoimmune diseases leading to progressive muscle weakness, often including the respiratory muscles. This study aims to investigate whether inspiratory muscle training (IMT) using a threshold device can improve functional status in patients with inflammatory myopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Myopathies
- What is being tested?
- Inspiratory Muscle Training (IMT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 sitePoland
- Study dates
- 12 Aug 2024to Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of inflammatory myopathy according to European Alliance of Associations for Rheumatology / American College of Rheumatology criteria
- Age ≥ 18 years
- Stable clinical condition allowing participation in physical activity
- Ability to understand and follow instructions
- Written informed consent to participate in the study
Who cannot join
- Cognitive impairment preventing proper exercise performance
- Current respiratory tract infection
- Previous respiratory muscle training within the last 12 months
- History of spontaneous pneumothorax
- Pulmonary hypertension
- Tympanic membrane rupture or other middle ear pathology
- Lack of voluntary and informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
University Clinical Center of the Medical University of Warsaw
Warsaw, 02-097
Jan Sznajder, PhD, +48696994812, jan.sznajder@awf.edu.pl
Agnieszka Lewińska, PhD, +48790013404, agnieszka.lewinska@awf.edu.pl
About this study
Official title: The Effect of Inspiratory Muscle Training on the Functional Status of Patients With Inflammatory Myopathy
Inflammatory myopathies are rare autoimmune diseases leading to progressive muscle weakness, often including the respiratory muscles. This study aims to investigate whether inspiratory muscle training (IMT) using a threshold device can improve functional status in patients with inflammatory myopathy. Thirty-three patients will undergo a 3-month home-based IMT program with progressive resistance. Functional capacity, inspiratory muscle strength, lung function, diaphragmatic mobility, fatigue, and quality of life will be assessed at baseline and during follow-up. The primary hypothesis is that IMT will enhance inspiratory muscle strength and translate into better functional performance and quality of life.
Read the detailed description
Idiopathic inflammatory myopathies (IIM) are rare autoimmune disorders characterized by progressive, symmetrical proximal muscle weakness, frequently affecting the respiratory muscles. Diaphragmatic dysfunction and reduced inspiratory muscle strength contribute to impaired ventilation, fatigue, and reduced exercise tolerance. While exercise training has proven beneficial in patients with various neuromuscular conditions, evidence regarding inspiratory muscle training (IMT) in IIM is lacking.
This pilot interventional study will prospectively evaluate the impact of a 3-month IMT program on respiratory and functional outcomes in patients with IIM. The intervention consists of daily inspiratory resistance training (30 breaths/day, 7 days/week) using the Threshold IMT device (Philips Respironics, USA). Training intensity is set at 30% of maximal inspiratory pressure (MIP) and adjusted progressively based on patient-reported exertion. Participants receive individualized instruction, follow-up phone consultations every 2 weeks, and record adherence in exercise diaries.
Assessments include inspiratory muscle strength (measured with Powerbreathe KH2), spirometry (Forced Expiratory Volume in 1 Second, Forced Vital Capacity, Forced Inspiratory Vital Capacity, Inspiratory Reserve Volume), diaphragm ultrasound (mobility and thickness fraction), six-minute walk test (6MWT), fatigue assessment (Borg Rating of Perceived Exertion Scale, Fatigue Severity Scale), and quality of life (36-Item Short Form Health Survey). Outcomes will be measured 3 months before training, at baseline, after 3 months of training, and during extended follow-up (up to 6-12 months). The primary endpoint is change in MIP. Secondary endpoints include pulmonary function parameters, diaphragmatic function, exercise tolerance, fatigue, and health-related quality of life.
The study will be conducted in the Neurology Clinic of the Medical University of Warsaw (WUM). A total of 33 patients with IIM, diagnosed according to European Alliance of Associations for Rheumatology / American College of Rheumatology criteria, will be recruited. Inclusion requires age ≥18 and written informed consent. Exclusion criteria include cognitive impairment, acute respiratory infection, prior respiratory training, pneumothorax, pulmonary hypertension, or contraindications to IMT. This trial is expected to provide the first structured evidence on the role of IMT in improving functional status in patients with inflammatory myopathy, potentially guiding individualized rehabilitation strategies for this patient population.
- Conditions
- Inflammatory Myopathies
- Being tested
- Inspiratory Muscle Training (IMT)
- Keywords
- Inspiratory muscle training, Diaphragm ultrasound, Respiratory muscle strength, Exercise tolerance
- Medical subject headings
- Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle Training (IMT)Behavioural
Inspiratory muscle training performed with a threshold loading device (Threshold IMT, Philips Respironics). Participants perform 30 breaths once daily, 7 days per week, for 3 months. The training load is set at 30% of maximal inspiratory pressure (MIP) and increased by 10% if the perceived exertion decreases on two consecutive training days. Participants receive individualized instruction and regular follow-up consultations (every 2 weeks) to adjust load and verify adherence.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training (IMT) | Experimental | Patients with inflammatory myopathy will perform a 3-month inspiratory muscle training (IMT) program using a threshold device (Philips Respironics Threshold IMT). Training will be home-based, preceded by individual instruction, and monitored through exercise diaries and follow-up phone consultations. Assessments will be performed before training, after 3 months, and during follow-up visits. Receives: Behavioral: Inspiratory Muscle Training (IMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal inspiratory pressure (MIP)
Maximal inspiratory pressure (MIP) measured at the mouth using Powerbreathe KH2 devices. Results are expressed in cmH₂O. Higher values indicate greater inspiratory muscle strength.
Measured: 3 months before training, baseline, 3 months (end of training), 6 months, 9 months, 12 months
Secondary outcomes (7)
Change in Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) assessed by spirometry using the EasyOne spirometer (NDD Medical Technologies). Results are expressed in liters (L) and as percent of predicted values (% predicted). Higher values indicate better pulmonary function.
Measured: 3 months before training, baseline, 3 months (end of training), 6 months, 9 months, 12 months
Change in Forced Expiratory Volume in 1 Second (FEV1)
Forced Expiratory Volume in 1 Second (FEV1) assessed by spirometry using the EasyOne spirometer (NDD Medical Technologies). Results are expressed in liters (L) and as percent of predicted values (% predicted). Higher values indicate better pulmonary function.
Measured: 3 months before training, baseline, 3 months (end of training), 6 months, 9 months, 12 months
Change in diaphragm thickness
Diaphragm thickness assessed by ultrasound using a Philips Lumify linear probe. Thickness is measured in millimeters (mm) at end-expiration and end-inspiration. Diaphragm thickening fraction (%) may be calculated from inspiratory and expiratory thickness measurements.
Measured: 3 months before training, baseline, 3 months (end of training), 6 months, 9 months, 12 months
Change in 6-Minute Walk Distance (6-Minute Walk Test)
Functional exercise capacity assessed by the 6-Minute Walk Test (6MWT), conducted on a 30 m corridor. The total distance walked in 6 minutes is recorded in meters. Greater distance indicates better functional exercise capacity.
Measured: 3 months before training, baseline, 3 months (end of training), 6 months, 9 months, 12 months
Change in perceived exertion (Borg Rating of Perceived Exertion)
Perceived exertion assessed using the Borg Rating of Perceived Exertion Scale (modified 0-10 scale). The scale ranges from 0 (no exertion) to 10 (maximal exertion), with higher scores indicating greater perceived exertion and fatigue.
Measured: 3 months before training, baseline, 3 months (end of training), 6 months, 9 months, 12 months
Change in fatigue severity (Fatigue Severity Scale)
Fatigue assessed using the Fatigue Severity Scale (FSS), a 9-item questionnaire in which each item is scored from 1 (strongly disagree) to 7 (strongly agree). The total score is calculated as the mean of the 9 items (range 1-7), with higher scores indicating greater fatigue severity.
Measured: 3 months before training, baseline, 3 months (end of training), 6 months, 9 months, 12 months
Change in quality of life (36-Item Short Form Health Survey)
Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36). The questionnaire includes eight domains scored from 0 to 100, with higher scores indicating better health status and quality of life.
Measured: 3 months before training, baseline, 3 months (end of training), 6 months, 9 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start12 Aug 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Inflammatory MyopathiesStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-group, prospective pilot intervention study evaluating the effects of inspiratory muscle training on functional status in patients with inflammatory myopathy. All participants receive the same inspiratory muscle training program and are followed for 12 months
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Józef Piłsudski University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274267
- Sponsor's protocol ID
- KB/91/2024
- Status last verified
- Nov 2025
- First submitted
- 27 Nov 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study involves a small sample of clinical patients and contains potentially identifiable medical information. Summary results will be made available through scientific publications and presentations.
Publications
Van Thillo A, Vulsteke JB, Van Assche D, Verschueren P, De Langhe E. Physical therapy in adult inflammatory myopathy patients: a systematic review. Clin Rheumatol. 2019 Aug;38(8):2039-2051. doi: 10.1007/s10067-019-04571-9. Epub 2019 May 21.
PubMed 31115788Ashton C, Paramalingam S, Stevenson B, Brusch A, Needham M. Idiopathic inflammatory myopathies: a review. Intern Med J. 2021 Jun;51(6):845-852. doi: 10.1111/imj.15358.
PubMed 34155760Lundberg IE, Miller FW, Tjarnlund A, Bottai M. Diagnosis and classification of idiopathic inflammatory myopathies. J Intern Med. 2016 Jul;280(1):39-51. doi: 10.1111/joim.12524.
PubMed 27320359
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inspiratory Muscle Training on the Functional Status of Patients With Inflammatory Myopathy
- ClinicalTrials.gov ID
- NCT07274267
- Acronym / sponsor ID
- KB/91/2024
- Conditions
- Inflammatory Myopathies
- Keywords
- Inspiratory muscle training, Diaphragm ultrasound, Respiratory muscle strength, Exercise tolerance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Józef Piłsudski University of Physical EducationUniversity, hospital or other
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Dec 2025 (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.
Inflammatory myopathies are rare autoimmune diseases leading to progressive muscle weakness, often including the respiratory muscles. This study aims to investigate whether inspiratory muscle training (IMT) using a threshold device can improve functional status in patients with inflammatory myopathy. Thirty-three patients will undergo a 3-month home-based IMT program with progressive resistance. Functional capacity, inspiratory muscle strength, lung function, diaphragmatic mobility, fatigue, and quality of life will be assessed at baseline and during follow-up. The primary hypothesis is that IMT will enhance inspiratory muscle strength and translate into better functional performance and quality of life.
Detailed description
Idiopathic inflammatory myopathies (IIM) are rare autoimmune disorders characterized by progressive, symmetrical proximal muscle weakness, frequently affecting the respiratory muscles. Diaphragmatic dysfunction and reduced inspiratory muscle strength contribute to impaired ventilation, fatigue, and reduced exercise tolerance. While exercise training has proven beneficial in patients with various neuromuscular conditions, evidence regarding inspiratory muscle training (IMT) in IIM is lacking.
This pilot interventional study will prospectively evaluate the impact of a 3-month IMT program on respiratory and functional outcomes in patients with IIM. The intervention consists of daily inspiratory resistance training (30 breaths/day, 7 days/week) using the Threshold IMT device (Philips Respironics, USA). Training intensity is set at 30% of maximal inspiratory pressure (MIP) and adjusted progressively based on patient-reported exertion. Participants receive individualized instruction, follow-up phone consultations every 2 weeks, and record adherence in exercise diaries.
Assessments include inspiratory muscle strength (measured with Powerbreathe KH2), spirometry (Forced Expiratory Volume in 1 Second, Forced Vital Capacity, Forced Inspiratory Vital Capacity, Inspiratory Reserve Volume), diaphragm ultrasound (mobility and thickness fraction), six-minute walk test (6MWT), fatigue assessment (Borg Rating of Perceived Exertion Scale, Fatigue Severity Scale), and quality of life (36-Item Short Form Health Survey). Outcomes will be measured 3 months before training, at baseline, after 3 months of training, and during extended follow-up (up to 6-12 months). The primary endpoint is change in MIP. Secondary endpoints include pulmonary function parameters, diaphragmatic function, exercise tolerance, fatigue, and health-related quality of life.
The study will be conducted in the Neurology Clinic of the Medical University of Warsaw (WUM). A total of 33 patients with IIM, diagnosed according to European Alliance of Associations for Rheumatology / American College of Rheumatology criteria, will be recruited. Inclusion requires age ≥18 and written informed consent. Exclusion criteria include cognitive impairment, acute respiratory infection, prior respiratory training, pneumothorax, pulmonary hypertension, or contraindications to IMT. This trial is expected to provide the first structured evidence on the role of IMT in improving functional status in patients with inflammatory myopathy, potentially guiding individualized rehabilitation strategies for this patient population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-group, prospective pilot intervention study evaluating the effects of inspiratory muscle training on functional status in patients with inflammatory myopathy. All participants receive the same inspiratory muscle training program and are followed for 12 months
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training (IMT) | Experimental | Behavioral: Inspiratory Muscle Training (IMT)Patients with inflammatory myopathy will perform a 3-month inspiratory muscle training (IMT) program using a threshold device (Philips Respironics Threshold IMT). Training will be home-based, preceded by individual instruction, and monitored through exercise diaries and follow-up phone consultations. Assessments will be performed before training, after 3 months, and during follow-up visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of inflammatory myopathy according to European Alliance of Associations for Rheumatology / American College of Rheumatology criteria
- Age ≥ 18 years
- Stable clinical condition allowing participation in physical activity
- Ability to understand and follow instructions
- Written informed consent to participate in the study
Key exclusion criteria (7 listed)
- Cognitive impairment preventing proper exercise performance
- Current respiratory tract infection
- Previous respiratory muscle training within the last 12 months
- History of spontaneous pneumothorax
- Pulmonary hypertension
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 Training (IMT)Inspiratory muscle training performed with a threshold loading device (Threshold IMT, Philips Respironics). Participants perform 30 breaths once daily, 7 days per week, for 3 months. The training load is set at 30% of maximal inspiratory pressure (MIP) and increased by 10% if the perceived exertion decreases on two consecutive training days. Participants receive individualized instruction and regular follow-up consultations (every 2 weeks) to adjust load and verify adherence. | Behavioural | Inspiratory Muscle Training (IMT) |
Primary outcome
Change in maximal inspiratory pressure (MIP)
Time frame: 3 months before training, baseline, 3 months (end of training), 6 months, 9 months, 12 months
Maximal inspiratory pressure (MIP) measured at the mouth using Powerbreathe KH2 devices. Results are expressed in cmH₂O. Higher values indicate greater inspiratory muscle strength.
7 secondary outcomes
Change in Forced Vital Capacity (FVC)
Time frame: 3 months before training, baseline, 3 months (end of training), 6 months, 9 months, 12 months
Change in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: 3 months before training, baseline, 3 months (end of training), 6 months, 9 months, 12 months
Change in diaphragm thickness
Time frame: 3 months before training, baseline, 3 months (end of training), 6 months, 9 months, 12 months
Change in 6-Minute Walk Distance (6-Minute Walk Test)
Time frame: 3 months before training, baseline, 3 months (end of training), 6 months, 9 months, 12 months
Change in perceived exertion (Borg Rating of Perceived Exertion)
Time frame: 3 months before training, baseline, 3 months (end of training), 6 months, 9 months, 12 months
Change in fatigue severity (Fatigue Severity Scale)
Time frame: 3 months before training, baseline, 3 months (end of training), 6 months, 9 months, 12 months
Change in quality of life (36-Item Short Form Health Survey)
Time frame: 3 months before training, baseline, 3 months (end of training), 6 months, 9 months, 12 months
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 25 Feb 2026.
- Background: PubMed 31115788Van Thillo A, Vulsteke JB, Van Assche D, Verschueren P, De Langhe E. Physical therapy in adult inflammatory myopathy patients: a systematic review. Clin Rheumatol. 2019 Aug;38(8):2039-2051. doi: 10.1007/s10067-019-04571-9. Epub 2019 May 21.
- Background: PubMed 34155760Ashton C, Paramalingam S, Stevenson B, Brusch A, Needham M. Idiopathic inflammatory myopathies: a review. Intern Med J. 2021 Jun;51(6):845-852. doi: 10.1111/imj.15358.
- Background: PubMed 27320359Lundberg IE, Miller FW, Tjarnlund A, Bottai M. Diagnosis and classification of idiopathic inflammatory myopathies. J Intern Med. 2016 Jul;280(1):39-51. doi: 10.1111/joim.12524.
- Academy of Physical Education in Warsaw - institutional websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study involves a small sample of clinical patients and contains potentially identifiable medical information. Summary results will be made available through scientific publications and presentations.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training (IMT) in people with Inflammatory Myopathies, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
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 7 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: looking for participants now, as of the sponsor's last update on 25 Feb 2026. 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 Poland. 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?
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 Jan Sznajder, PhD (+48696994812, jan.sznajder@awf.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximal inspiratory pressure (MIP) (time frame: 3 months before training, baseline, 3 months (end of training), 6 months, 9 months, 12 months). 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 NCT07274267, which also lists 3 linked publications.
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 25 Feb 2026.