Effect of Exercise on Disease Activity and Cardiovascular Risk Factors in Patients With AS: A Single Blind Randomized Controlled Trail
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ankylosing Spondyliti
- Sponsor
- Diakonhjemmet Hospital
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Disease activity
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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
Investigators
Silje H Sveaas, PT, PhD
PhD.student
Diakonhjemmet Hospital
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
Outcomes
Primary Outcomes
Disease activity
Time Frame: 12 weeks after baseline assessment
The Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) will be used to assess disease activity. It is a continuous measure based on patient-reported outcomes (back pain, duration of morning stiffness, patient global assessment and peripheral join complaints) and CRP, and higher values indicate higher disease activity. The minimal clinically important improvement for this instrument is reported to be ∆ ≥1.1, and ∆ ≥2.0 is considered a major improvement.
Secondary Outcomes
- Body composition(12 weeks after baseline assessment)
- General health(12 weeks after baseline assessment)
- Blood samples(12 weeks after baseline assessment)
- Blood pressure(12 weeks after baseline assessment)
- Physical function(12 weeks after baseline assessment)
- Electrocardiography(12 weeks after baseline assessment)
- Physical fitness(12 weeks after baseline assessment)
- Physical activity level(12 weeks after baseline assessment and 12 months after the intervention)