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

Effect of Exercise on Disease Activity and Cardiovascular Risk Factors in Patients With AS: A Single Blind Randomized Controlled Trail

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

Study Overview

• Status: Completed
• Conditions: Ankylosing Spondyliti
• Intervention / Treatment: Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Diakonhjemmet Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Exercise group	Behavioral: Exercise; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease activity	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.	12 weeks after baseline assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrocardiography	To measure the electrical activity of the heart.	12 weeks after baseline assessment
Blood samples	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)	12 weeks after baseline assessment
Blood pressure		12 weeks after baseline assessment
Physical fitness	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).	12 weeks after baseline assessment
Body composition	Weight, height, waist circumference will be measured. Dual Energy X-ray Absortiometry (DEXA) will be used to assess body composition.	12 weeks after baseline assessment
Physical function	Will be assessed with the patient reported index Bath Ankylosing Spondylitis Functional Index (BASFI).	12 weeks after baseline assessment
General health	Will be assessed with the generic General Health Questionnaire (GHQ-12).	12 weeks after baseline assessment
Physical activity level	Will be assessed with the International Physical Activity Questionnaire short version (IPAQ-s).	12 weeks after baseline assessment and 12 months after the intervention

Collaborators and Investigators

• Sponsor: Diakonhjemmet Hospital
• Collaborators: University of Oslo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: September 13, 2011
• First Submitted That Met QC Criteria: September 16, 2011
• First Posted (Estimate): September 20, 2011

Study Record Updates

• Last Update Posted (Estimate): February 3, 2015
• Last Update Submitted That Met QC Criteria: February 2, 2015
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: Diakonhjemmet Hospital