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

This study has been completed.
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Silje Halvorsen, PhD.student, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier:
NCT01436942
First received: September 13, 2011
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention
Ankylosing Spondylitis
 Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Exercise on Disease Activity and Cardiovascular Risk Factors in Patients With AS: A Single Blind Randomized Controlled Trail

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Diakonhjemmet Hospital:

Primary Outcome Measures:
  • Disease activity [ Time Frame: 12 weeks after baseline assessment ] [ Designated as safety issue: No ]
    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:
  • Electrocardiography [ Time Frame: 12 weeks after baseline assessment ] [ Designated as safety issue: No ]
    To measure the electrical activity of the heart.

  • Blood samples [ Time Frame: 12 weeks after baseline assessment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Physical fitness [ Time Frame: 12 weeks after baseline assessment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Will be assessed with the patient reported index Bath Ankylosing Spondylitis Functional Index (BASFI).

  • General health [ Time Frame: 12 weeks after baseline assessment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Will be assessed with the International Physical Activity Questionnaire short version (IPAQ-s).


Enrollment: 34
Study Start Date: September 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
No Intervention: Control group

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436942

Locations
Norway
Diakonhjemmet Hospital
Oslo, Norway
Sponsors and Collaborators
Diakonhjemmet Hospital
University of Oslo
  More Information

No publications provided

Responsible Party: Silje Halvorsen, PhD.student, PhD.student, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier: NCT01436942     History of Changes
Other Study ID Numbers: Diakonhjemmet Hospital
Study First Received: September 13, 2011
Last Updated: March 18, 2013
Health Authority: Norway: National Committee for Medical Research Ethic

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
 Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on May 16, 2013