Clinical trial NCT01436942: Effect of Exercise on Disease Activity and Cardiovascular Risk Factors in Patients With Ankylosing Spondylitis
Official title: Effect of Exercise on Disease Activity and Cardiovascular Risk Factors in Patients With AS: A Single Blind Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankylosing Spondyliti
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2011-09-20
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background:

Exercise is recommended as a cornerstone in the treatment of ankylosing spondylitis together with medication. Last years, increased risk of cardiovascular diseases in patient with inflammatory diseases is reported, probably caused by inflammation and increased prevalence of traditional risk factors. In both healthy adults and other patient groups, cardiorespiratory and muscular strength exercises have been shown to have a positive effect on inflammation as well as on cardiovascular risk factors. To our knowledge this has not been shown in patients with ankylosing spondylitis.

Objective: The aim of this study is to investigate the effects of a cardiorespiratory and muscular strength exercise program on disease activity and cardiovascular risk factors in patients with ankylosing spondylitis


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ankylosing spondylitis, confirmed by a rheumatologist
* Age, 18-70 years
* Not using TNF-α medication or steady medication for ≥3 months
* Disease activity ≥2.1 on ankylosing spondylitis disease activity score defined as high disease activity
* Not participated in a structured cardiorespiratory or muscle strengthening exercise program during the last year (\>60 min once per week), including large amounts of brisk walking (\>120 min per week)

Exclusion Criteria:

* Known cardiovascular disease
* Severe comorbidity which involves reduced exercise capacity
* Not able to participate in weekly exercises sessions in Oslo
* Pregnancy

Primary outcomes:
measure: Disease activity
timeFrame: 12 weeks after baseline assessment
Secondary outcomes:
measure: Electrocardiography
timeFrame: 12 weeks after baseline assessment
measure: Blood samples
timeFrame: 12 weeks after baseline assessment
measure: Blood pressure
timeFrame: 12 weeks after baseline assessment
measure: Physical fitness
timeFrame: 12 weeks after baseline assessment
measure: Body composition
timeFrame: 12 weeks after baseline assessment
measure: Physical function
timeFrame: 12 weeks after baseline assessment
measure: General health
timeFrame: 12 weeks after baseline assessment
measure: Physical activity level
timeFrame: 12 weeks after baseline assessment and 12 months after the intervention
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
Study officials:
References:
citation: Sveaas SH, Berg IJ, Provan SA, Semb AG, Hagen KB, Vollestad N, Fongen C, Olsen IC, Michelsen A, Ueland T, Aukrust P, Kvien TK, Dagfinrud H. Efficacy of high intensity exercise on disease activity and cardiovascular risk in active axial spondyloarthritis: a randomized controlled pilot study. PLoS One. 2014 Sep 30;9(9):e108688. doi: 10.1371/journal.pone.0108688. eCollection 2014.