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

NCT01436942 | Completed DMC

• 1 other identifier: Diakonhjemmet Hospital
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Ankylosing Spondyliti

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Electrocardiography

  12 weeks after baseline assessment

• Blood samples

  12 weeks after baseline assessment

• Blood pressure

  12 weeks after baseline assessment

• Physical fitness

  12 weeks after baseline assessment

• Body composition

  12 weeks after baseline assessment

Study Arms (2)

Exercise group

EXPERIMENTAL

Behavioral: Exercise

Control group

NO INTERVENTION

Interventions

Exercise BEHAVIORAL

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.

Exercise group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Known cardiovascular disease
• Severe comorbidity which involves reduced exercise capacity
• Not able to participate in weekly exercises sessions in Oslo
• Pregnancy

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead
• University of Oslo: collaborator

Study Sites (1)

Diakonhjemmet Hospital

Oslo, Norway

Location

Related Publications (1)

• 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.

  PMID: 25268365 DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD.student

Study Record Dates

• First Submitted: September 13, 2011
• First Posted: September 20, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: February 3, 2015

Record last verified: 2013-03

Locations

NO (1)