Impact of Inspiratory Muscle Training on Breathing and Exercise in Ankylosing Spondylitis
Effect of Inspiratory Muscle Training on Respiratory Functions and Exercise Capacity in Patients With Ankylosing Spondylitis Receiving Anti-TNF Therapy: Randomized Controlled Study.
This study is testing if a special breathing exercise program can help people with ankylosing spondylitis breathe better and improve their ability to exercise while they are on anti-TNF treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Kayseri City Hospital Government |
| Locations | 1 site (Kayseri) |
| Trial ID | NCT06287983 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of inspiratory muscle training combined with anti-TNF treatment on respiratory functions and exercise capacity in patients with ankylosing spondylitis (AS). Patients diagnosed with AS who have been on anti-TNF therapy for at least six months will participate in a structured exercise program, which includes inspiratory muscle training. The study aims to assess the relationship between pulmonary function, exercise performance, disease activity, spinal mobility, and quality of life. A total of 44 patients will be randomly assigned to either the intervention or control group for a six-week exercise regimen.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with ankylosing spondylitis who have been receiving anti-TNF therapy for at least six months and have specific pulmonary function test results.
Not a fit: Patients with serious mental disorders, uncontrolled hypertension, diabetes, or other significant cardiac or pulmonary conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance respiratory function and overall exercise capacity in patients with ankylosing spondylitis.
How similar studies have performed: While the specific combination of inspiratory muscle training and anti-TNF therapy in AS is novel, similar approaches in other conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with ankylosing spondylitis according to the Modified New York Criteria * Patients with BASDAI score \<4.1 who received Anti-TNF therapy for at least 6 months * Patients whose maximum inspiratory pressure value is \<80% in the Pulmonary Function Test * Patients who had a cardiac examination within the last year and no cardiac pathology was detected. Exclusion Criteria: * The patient has a serious mental disorder * Presence of neurological and pulmonary disease that would prevent the patient from using the PFT device * Presence of uncontrolled hypertension * Presence of uncontrolled diabetes * Presence of uncontrolled cardiac arrhythmia * Uncontrolled heart failure * High-risk unstable angina and all acute cardiac diseases (acute myocardial infarction, acute endocarditis, myocarditis or pericarditis) * Symptomatic severe aortic stenosis * Acute pulmonary embolism or pulmonary infarction * Severe pulmonary hypertension * Presence of systemic infection or malignancy * Pregnancy
Where this trial is running
Kayseri
- Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital — Kayseri, Turkey (Recruiting)
Study contacts
- Principal investigator: Esra Yaprak tas — Saglik Bilimleri Universitesi
- Study coordinator: Havva Talay Calıs, Prof
- Email: htalaycalis@yahoo.com
- Phone: +90532 687 45 41
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.