Effects of Cardiovascular Training in Individuals With Ankylosing Spondylitis

NCT ID: NCT00913302

Last Updated: 2013-07-08

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

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-11-30

Brief Summary

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To test the effects of a cardiovascular training compared to attention control in a group of AS-patients participating in classic spinal mobility exercise groups (randomized controlled trial)

Detailed Description

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Ankylosing spondylitis (AS) is a chronic inflammatory rheumatic disease, affecting primarily the spinal column and iliosacral joints. In addition, an increased risk for cardio-vascular disease and osteoporosis has been described in patients with AS. Patients with AS may suffer from severe impairment in physical functioning, i.e. spinal stiffness, pain and fatigue, which reduces their daily activities, and quality of life. As AS mainly affects young people, work capacity may be reduced, which, together with medical treatment costs, results in a considerable burden for the society.

Current treatment guidelines for AS (ASAS/EULAR 2006) propose drug treatment, mainly non-steroidal anti-inflammatory drugs, and in severe cases inhibitors of TNF alpha. In addition, mobility exercise as the cornerstone of functional training is recommended in all patients with AS. The efficacy of mobility exercise was confirmed by the third update (2007, unpublished) of the Cochrane review regarding Physiotherapy in AS. However, the review also suggested that mobility exercises have no effect on important quality-of life related outcomes, such as pain, fatigue, or cardiovascular fitness.

Reduced physical activity due to pain, fatigue and reduced cardiovascular fitness may put patients with AS at increased risk for immobility-induced bone loss and vitamin D deficiency due to limited outdoor activities. Finally, both inactivity and vitamin D deficiency may contribute to the elevated risk for cardiovascular disease and osteoporosis in patients with AS.

Cardiovascular training may increase cardiovascular fitness, reduce pain and fatigue, and decrease bone loss. The intervention may also enhance vitamin D status by increasing the amount of physical activity performed outside. Vitamin D has been found to reduce bone loss and improve cardiovascular health.

Conditions

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Ankylosing Spondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Training

cardiovascular training

Group Type EXPERIMENTAL

Cardiovascular Training

Intervention Type BEHAVIORAL

cardiovascular training, 3 times/week for 30-60 minutes, over 12 weeks

Interventions

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Cardiovascular Training

cardiovascular training, 3 times/week for 30-60 minutes, over 12 weeks

Intervention Type BEHAVIORAL

Other Intervention Names

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fitness exercise

Eligibility Criteria

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Inclusion Criteria

* Age 18-75 years
* Diagnosis of AS following the modified New York criteria
* Ability to cycle on a training bicycle
* Sufficient German language ability (for questionnaires)
* Willingness to follow the study protocol / informed consent

Exclusion Criteria

* Chronic heart failure, functional NYHA Class III and IV
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Swiss Ankylosing Spondylitis Association

UNKNOWN

Sponsor Role collaborator

Federal Office of Sports, Switzerland

OTHER_GOV

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heike Bischoff Ferrari, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Centre on Aging and Mobility

Locations

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University Hospital Zurich, Centre on Aging and Mobility

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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Niedermann K, Sidelnikov E, Muggli C, Dagfinrud H, Hermann M, Tamborrini G, Ciurea A, Bischoff-Ferrari H. Effect of cardiovascular training on fitness and perceived disease activity in people with ankylosing spondylitis. Arthritis Care Res (Hoboken). 2013 Nov;65(11):1844-52. doi: 10.1002/acr.22062.

Reference Type DERIVED
PMID: 23836515 (View on PubMed)

Other Identifiers

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746

Identifier Type: -

Identifier Source: org_study_id

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