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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02356874
• Date of registration: 21/01/2015
• Prospective Registration: Yes
• Primary sponsor: Diakonhjemmet Hospital
• Public title: The Effect of Exercise on Disease Activity and Cardiovascular Risk for Patients With Axial SpondyloArthritis ESpA
• Scientific title: Exercise for SpondyloArthritis (SpA) - the ESpA Study The Effect of a Supervised Exercise Intervention on Disease Activity and Cardiovascular Risk in Patients With SpA - A Multicenter Randomized Controlled Trial
• Date of first enrolment: August 2015
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02356874
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Norway, Sweden

Contacts

• Name: Hanne H Dagfinrud, PhD
• Affiliation: Nationonal Advisory Unit on Rehabilitation in Rheumatology, Departement of Rheumatology, Diakonhjemmet Hospital

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Axial Spondyloarthritis

Intervention(s)

Behavioral: Exercise

Primary Outcome(s)

Disease activity [Time Frame: 3 months]

Secondary Outcome(s)

Spinal mobility [Time Frame: 3 months]

Arterial stiffness [Time Frame: 3 months]

Blood pressure [Time Frame: 3 months]

Endothelial function [Time Frame: 3 months]

Body composition [Time Frame: 3 months]

General health [Time Frame: 3 months and 12 months]

Physical function [Time Frame: 3 months and 12 months]

Blood samples [Time Frame: 3 months (all analyses) 12 months (only CRP and ESR)]

Cardiorespiratory fitness [Time Frame: 3 months]

Fatigue [Time Frame: 3 months and 12 months]

Self-efficacy for physical activity [Time Frame: 3 months and 12 months]

Health related quality of life [Time Frame: 3 months and 12 months]

Physical activity level [Time Frame: 3 months and 12 months]

Sleep [Time Frame: 3 months and 12 months]

Secondary ID(s)

97026: The ESpA study

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Oslo

Norwegian School of Sport Sciences