Inspiratory muscle training for people with inflammatory myopathy
The Effect of Inspiratory Muscle Training on the Functional Status of Patients With Inflammatory Myopathy
This project will test whether a 3-month home-based inspiratory muscle training program can strengthen breathing muscles and improve walking distance, fatigue, and quality of life for adults with inflammatory myopathy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Józef Piłsudski University of Physical Education Academic / other |
| Locations | 1 site (Warsaw) |
| Trial ID | NCT07274267 on ClinicalTrials.gov |
What this trial studies
This pilot interventional program enrolls 33 adults with inflammatory myopathy to complete a 3-month home-based inspiratory muscle training (IMT) regimen using a Threshold IMT device, with daily sessions of 30 breaths and progressive resistance starting at 30% of maximal inspiratory pressure. Participants receive individualized instruction, biweekly phone follow-up, and record adherence in exercise diaries. Outcomes measured at baseline and follow-up include inspiratory muscle strength, spirometry, diaphragm ultrasound, six-minute walk distance, fatigue scales, and quality-of-life questionnaires. The study aims to link improvements in inspiratory muscle strength to better functional performance and patient-reported outcomes.
Who should consider this trial
Good fit: Adults (≥18) with a confirmed diagnosis of inflammatory myopathy who are clinically stable, able to perform and follow a home exercise program, and able to give informed consent are ideal candidates.
Not a fit: Patients with active respiratory infection, recent respiratory muscle training, history of spontaneous pneumothorax, pulmonary hypertension, certain ear pathologies, cognitive impairment, or inability to follow the program may not receive benefit or may be excluded.
Why it matters
Potential benefit: If successful, IMT could increase inspiratory muscle strength, reduce breathlessness and fatigue, and improve exercise tolerance and quality of life for people with inflammatory myopathy.
How similar studies have performed: Inspiratory muscle training has shown benefits in other neuromuscular and respiratory conditions, but direct evidence in inflammatory myopathy is limited and this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Warsaw
- University Clinical Center of the Medical University of Warsaw — Warsaw, Poland (Recruiting)
Study contacts
- Study coordinator: Jan Sznajder, PhD
- Email: jan.sznajder@awf.edu.pl
- Phone: +48696994812
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.