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Active Not Recruiting NCT07923006

Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis

Conditions: Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 48
Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

Location: Sisli Hamidiye Etfal Training and Research Hospital Istanbul

Summary

This prospective, randomized, single-blind controlled study aims to evaluate the effects of resistance exercises on clinical and ultrasonographic findings of enthesitis in patients with spondyloarthritis. Participants were randomly assigned to two groups. The intervention group performs resistance exercises in addition to a walking program, while the control group follows a walking program alone. Patients in the intervention group undergo resistance exercise sessions three days per week for 12 weeks. The primary outcomes are changes in ultrasonographic enthesitis scores measured using the Madrid Sonographic Enthesitis Index (MASEI) and Glasgow Ultrasound Enthesitis Scoring System (GUESS). Secondary outcomes include tendon stiffness assessed by shear-wave elastography, clinical enthesitis scores, disease activity, physical function, and quality of life. Outcomes are assessed at baseline and at week 12.

Eligibility Criteria

Inclusion Criteria: * Adults aged 18-65 years. * Diagnosis of spondyloarthritis (SpA) fulfilling the Assessment of SpondyloArthritis International Society (ASAS) classification criteria. * Baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score below 4. * No initiation of a new biologic agent within the preceding three months and continuation of existing medical treatment. * Absence of any physical or neurological condition that would prevent participation in the exercise program. * Willingness to participate in the study and provision of written informed consent. Exclusion Criteria: * Initiation of biologic therapy or dose modification of an existing biologic agent within the preceding three months. * Presence of a systemic infection. * Pregnancy or breastfeeding. * Presence of malignancy. * Orthopedic or cardiopulmonary conditions that may contraindicate exercise. * Neurological disorders causing motor dysfunction. * Corticosteroid injection into any of the entheseal sites to be evaluated within the preceding six weeks. * Presence of infection, open wounds, or peripheral neuropathy at the anatomical sites to be assessed. * History of surgery, trauma, or malformation at the anatomical sites to be evaluated. * Presence of another concomitant rheumatic disease. * Use of fluoroquinolones, retinoids, or fluoride. * Diagnosis of fibromyalgia syndrome (FMS) or clinical findings suggestive of FMS during assessment.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07923006). StuddyBuddy aggregates publicly available trial information.