Effect of Exercise on Disease Activity and Cardiovascular Risk Factors in Patients With Ankylosing Spondylitis

Not Applicable

Completed

• Conditions: Ankylosing Spondyliti
• Interventions: Behavioral: Exercise

• Registration Number: NCT01436942
• Lead Sponsor: Diakonhjemmet Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-13
• Study First Submitted QC: 2011-09-16
• Study First Posted: 2011-09-20
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-03
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise group	Exercise	-

Primary Outcome Measures

Name	Time	Method
Disease activity	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 Outcome Measures

Name	Time	Method
Body composition	12 weeks after baseline assessment	Weight, height, waist circumference will be measured. Dual Energy X-ray Absortiometry (DEXA) will be used to assess body composition.
General health	12 weeks after baseline assessment	Will be assessed with the generic General Health Questionnaire (GHQ-12).
Blood samples	12 weeks after baseline assessment	Analyzed for both general and endothelial specific markers of inflammation and cardiovascular risk(total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, glucose, NTproBNP, TNF-α, IL-6, IL-18, high sensitive C-reactive protein and sedimentation rate)
Blood pressure	12 weeks after baseline assessment
Physical function	12 weeks after baseline assessment	Will be assessed with the patient reported index Bath Ankylosing Spondylitis Functional Index (BASFI).
Electrocardiography	12 weeks after baseline assessment	To measure the electrical activity of the heart.
Physical fitness	12 weeks after baseline assessment	Cardiorespiratory fitness will be assessed with an indirect maximal walking test on a treadmill for estimation of peak oxygen uptake according to modified Balke protocol. Hand grip strength will be assessed with GRIPPIT. Spinal and hip mobility will be assessed with the Bath Ankylosing Spondylitis Metrology index (BASMI), and chest expansion will be measured as the difference between maximal inspiration and expiration at the level of xipoideus (cm).
Physical activity level	12 weeks after baseline assessment and 12 months after the intervention	Will be assessed with the International Physical Activity Questionnaire short version (IPAQ-s).

Trial Locations

Locations (1)

Diakonhjemmet Hospital; 🇳🇴 Oslo, Norway