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Effect of high-intensity endurance training on bone marrow edema in individuals with axial spondyloarthritis (axSpA): a randomized controlled trial (ECHO).

Not Applicable
Recruiting
Conditions
M45
Ankylosing 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
Inclusion Criteria

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

Exclusion Criteria

- 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
NameTimeMethod
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
NameTimeMethod
- 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
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