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

NCT ID: NCT01436942

Last Updated: 2015-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-05-31

Brief Summary

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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

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Conditions

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Ankylosing Spondyliti

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Exercise group

Group Type EXPERIMENTAL

Exercise

Intervention Type 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.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oslo

OTHER

Sponsor Role collaborator

Diakonhjemmet Hospital

OTHER

Sponsor Role lead

Responsible Party

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Silje H Sveaas, PT, PhD

PhD.student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Diakonhjemmet Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 25268365 (View on PubMed)

Other Identifiers

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Diakonhjemmet Hospital

Identifier Type: -

Identifier Source: org_study_id

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