Effect of high-intensity endurance training on bone marrow edema in individuals with axial spondyloarthritis (axSpA): a randomized controlled trial (ECHO).
- Conditions
- M45Ankylosing spondylitis
- Registration Number
- DRKS00032901
- Lead Sponsor
- Rheumazentrum Ruhrgbiet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 125
Confirmed clinical diagnosis of axSpA
- axSpA patients with stable bionaive medication
- axSpA patients with stable TNFi (b-DMARD) Medication
- age > 18 years
- Eligibility for participation in performance diagnostics and in the high-intensity interval training on the cycle ergometer
- axSpA patients* with other b- or ts-DMARDs. Medication
- Individuals with significant limitations in physical functioning due to a concomitant concomitant disease
- Patients who are not scheduled for MRI as part of routine treatment no MRI examination is planned
- Pregnant/breastfeeding women
- Unstable CVD
- Angina pectoris CCS class = I
- Signs of heart failure
- Acute hypertensive derangement or Inadequately controlled arterial hypertension
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amount of BME lesions in the spine and sacroiliac (calculated with the Berlin Score) which occurred in the last 3 months have occurred
- Secondary Outcome Measures
Name Time Method - Amount of bone marrow edema (BME) lesions in the spine and sacroiliac joint (calculated with the Berlin Score) that have resolved in the last have resolved in the last 3 months<br>- Amount of subjects who had no positive imaging during the 3 positive imaging (calculated with the Berlin Score) in the course of the 3 months<br>- Change in disease activity (ASDAS) after 3 months of HIIT<br>- Change in physical performance<br>- Change in physical functioning (BASFI) after 3 months of HIIT<br>- Change in the mSAQUASH/ or other arc for recording physical activity<br>- Change in the number of pressure painful tendon insertions (enthesitis score SPARCC)<br>- Change in ASAS-NSAIDs score over 3 months<br>- Change in pain on the numeric Rating Scale (NRS) 0 - 10 over 3 months.<br>- Change in ASAS health index,<br>- Change in BASDAI,<br>- Change in Patient Global,<br>- Change in modified Squash Questionnaire,<br>- Change in SF-36,<br>- change in EQ-5D<br>- Change in BASMI