Effect of Exercise on Disease Activity and Cardiovascular Risk Factors in Patients With Ankylosing Spondylitis
|ClinicalTrials.gov Identifier: NCT01436942|
Recruitment Status : Completed
First Posted : September 20, 2011
Last Update Posted : February 3, 2015
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
|Condition or disease||Intervention/treatment|
|Ankylosing Spondyliti||Behavioral: Exercise|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Effect of Exercise on Disease Activity and Cardiovascular Risk Factors in Patients With AS: A Single Blind Randomized Controlled Trail|
|Study Start Date :||September 2011|
|Primary Completion Date :||May 2012|
|Study Completion Date :||May 2012|
|Experimental: Exercise group||
The exercise intervention will be carried out at a fitness center with supervision from a physiotherapist.
A cardiorespiratory and muscle strengthening exercise program following the American College of Sports Medicine (ACSM) recommendations for maintenance and improvement of physical fitness. Cardiorespiratory fitness: two interval sessions (4 x 4 min), one continuous moderate exercise session (40 min) on a treadmill. The muscle strength exercises will consist of: 15-20 repetitions, large muscle groups as thighs, back and abdomen.
Dose: 12 weeks. Three times a week, 60 minutes.
|No Intervention: Control group|
- 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.
- Electrocardiography [ Time Frame: 12 weeks after baseline assessment ]To measure the electrical activity of the heart.
- Blood samples [ Time Frame: 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 [ Time Frame: 12 weeks after baseline assessment ]
- Physical fitness [ Time Frame: 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).
- Body composition [ Time Frame: 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.
- Physical function [ Time Frame: 12 weeks after baseline assessment ]Will be assessed with the patient reported index Bath Ankylosing Spondylitis Functional Index (BASFI).
- General health [ Time Frame: 12 weeks after baseline assessment ]Will be assessed with the generic General Health Questionnaire (GHQ-12).
- Physical activity level [ Time Frame: 12 weeks after baseline assessment and 12 months after the intervention ]Will be assessed with the International Physical Activity Questionnaire short version (IPAQ-s).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01436942