The Effect of Exercise on Disease Activity and Cardiovascular Risk for Patients With Axial SpondyloArthritis

Not Applicable

Completed

• Conditions: Axial Spondyloarthritis

• Registration Number: NCT02356874
• Lead Sponsor: Diakonhjemmet Hospital

Brief Summary

The overall aim of this multicenter randomised controlled trial (RCT) is to investigate if exercise can modify the disease course and prevent comorbidity in patient with spondyloarthritis (SpA).

Detailed Description

International guidelines recommend exercise as a cornerstone in the management of SpA. Due to the typical features of SpA with reduced spinal mobility, the main focus for exercise has been flexibility exercise. Exercise trials for this patient group have mainly aimed at improving spinal mobility and there is limited evidence of the potential effects of exercise on disease pathogenesis and CVD risk factors.

Study Timeline

• Study First Submitted: 2015-01-21
• Study First Submitted QC: 2015-02-02
• Study First Posted: 2015-02-05
• Study Start: 2015-08
• Primary Completion: 2016-12
• Status Verified: 2017-02
• Study Completion: 2017-09
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Diagnosis of axial SpA (the Assessment of SpondyloArthritis International Society classification criteria) confirmed by a rheumatologist
2. Age, 18-70 -years
3. Steady medication for ≥3 months
4. Moderate disease activity defined as a BASDAI score of ≥3.5 or a patient global score ≥3.5
5. Not participated in a structured endurance and strength exercise program during the last 6 months (>1 hour/week)

Exclusion Criteria

1. Severe co-morbidity which involves reduced exercise capacity and/or contraindications for physical activity as per American College of Sports Medicine guidelines for exercise testing
2. Not able to participate in weekly exercises sessions
3. Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Disease activity	3 months	The Ankylosing Spondylitis Disease Activity Score (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Secondary Outcome Measures

Name	Time	Method
Blood samples	3 months (all analyses) 12 months (only CRP and ESR)	General and specific markers of inflammation and cardiovascular risk
Spinal mobility	3 months	The Bath Ankylosing Spondylitis Metrology Index (BASMI). BASMI includes five measurements of flexibility in the spine, neck and hips.
Physical function	3 months and 12 months	The Bath Ankylosing Spondylitis functional Index (BASFI).
Cardiorespiratory fitness	3 months	Maximal walking test on a treadmill for estimation of maximal oxygen uptake.
Body composition	3 months	Body weight, body height, waist and hip circumference. DXA scan of a sample of patients.
Blood pressure	3 months
General health	3 months and 12 months	Assessed with the general health questionnaire (GHQ-12)
Health related quality of life	3 months and 12 months	Euro Quol 5D (EQ5D)
Physical activity level	3 months and 12 months	Questionaire of frequency, intensity and duration of physical activity
Self-efficacy for physical activity	3 months and 12 months	Questionnaire
Fatigue	3 months and 12 months	The fatigue severity scale and the SF-36 vitality scale (version 1)
Sleep	3 months and 12 months	Pittsburgh Sleep Quality Index (PSQI)
Arterial stiffness	3 months	Pulse wave velocity and argumentation Index
Endothelial function	3 months	Digital plethysmography using the non-invasive ADMAR apparatus (sample of participants)

Trial Locations

Locations (4)

Martina Hansens Hospital AS; 🇳🇴 Bærum, Norway

Diakonhjemmet Hospital AS; 🇳🇴 Oslo, Norway

University Hospital of North Norway; 🇳🇴 Tromsø, Norway

University of Gotenburg; 🇸🇪 Gotenburg, Sweden