Inspiratory muscle training added to pulmonary rehabilitation for people with RA-related interstitial lung disease
Investigation of the Effects of Standard Rehabilitation Program and Inspiratory Muscle Training on lncRNA HOTAIR Expression in Patients With Rheumatoid Arthritis
NA · Saglik Bilimleri Universitesi · NCT07320846
This project will test whether adding inspiratory muscle training to standard pulmonary rehabilitation helps people with rheumatoid arthritis-associated interstitial lung disease breathe easier, walk farther, gain muscle strength, feel better psychologically, and change levels of certain long noncoding RNAs.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Saglik Bilimleri Universitesi (other) |
| Locations | 1 site (Istanbul, Turkey) |
| Trial ID | NCT07320846 on ClinicalTrials.gov |
What this trial studies
Adults with rheumatoid arthritis-associated interstitial lung disease will participate in a standard pulmonary rehabilitation program, with some receiving added resistive threshold inspiratory muscle training and others receiving standard care or no added intervention. Clinical outcomes including exercise capacity, dyspnea, inspiratory muscle strength, quality of life, and psychological state will be measured before and after the intervention. Blood samples will be collected to measure changes in long noncoding RNA expression related to the rehabilitation interventions. The design aims to link functional rehabilitation gains with underlying molecular changes to see if added inspiratory muscle training provides extra benefit.
Who should consider this trial
Good fit: Ideal candidates are adults with rheumatoid arthritis (diagnosed >2 years) who have documented lung involvement, a DAS28 score below 5.1, BMI ≤30, and who have not participated in a rehabilitation program in the past 6 months.
Not a fit: Patients with severe organ failure, uncontrolled diabetes or heart disease, recent acute coronary syndrome, active infection, pregnancy, orthopedic conditions that limit participation, or BMI >30 are unlikely to benefit or will be excluded.
Why it matters
Potential benefit: If successful, adding inspiratory muscle training could improve breathing, exercise tolerance, muscle strength, and quality of life for people with RA-associated ILD and identify molecular markers of response.
How similar studies have performed: Inspiratory muscle training has shown benefits for strength, dyspnea, and exercise capacity in COPD and some ILD populations, but applying it specifically to RA-associated ILD and measuring long noncoding RNA changes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with RA according to the ACR/EULAR 2010 classification criteria * Duration of diagnosis greater than 2 years * Disease activity with a DAS28 score below 5.1 * Voluntary participation in the study * Presence of lung involvement Exclusion Criteria: * Having orthopedic deformities that may affect the treatment program * Pregnancy * Uncontrolled diabetes or heart disease * Participation in a rehabilitation program within the last 6 months * Body Mass Index (BMI) \> 30 * Patients with severe organ failure * Recent acute coronary syndrome * Presence of active infection
Where this trial is running
Istanbul, Turkey
- University of Health Sciences — Istanbul, Turkey, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Zeynep Betül ÖZCAN, PhD (c) — Saglik Bilimleri Universitesi
- Study coordinator: Zeynep Betül ÖZCAN
- Email: zbetulozcan@gmail.com
- Phone: +90 216 346 36 36
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.
Conditions: Exercise, Pulmonary Rehabilitation, Interstitial Lung Disease, Long Noncoding RNA, Inspiratory Muscle Training, Rheumatoid Arthritis, inspiratory muscle training, long noncoding RNA