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Effects of Cardiovascular Training in Individuals With Ankylosing Spondylitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University of Zurich.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Swiss Ankylosing Spondylitis Association
Federal Office of Sports, Switzerland
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00913302
First received: May 14, 2009
Last updated: February 23, 2010
Last verified: February 2010
History of Changes
  Purpose

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)


Condition Intervention
Ankylosing Spondylitis
 Behavioral: Cardiovascular Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effects of Cardiovascular Training on Fitness, Cardiovascular Health, Bone Health and Quality of Life in Individuals With Ankylosing Spondylitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Cardiovascular Fitness [ Time Frame: Baseline and post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 112
Study Start Date: January 2008
Estimated Study Completion Date: September 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Training
cardiovascular training
 Behavioral: Cardiovascular Training
cardiovascular training, 3 times/week for 30-60 minutes, over 12 weeks
Other Names:
  • fitness
  • exercise

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913302

Locations
Switzerland
University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Swiss Ankylosing Spondylitis Association
Federal Office of Sports, Switzerland
Investigators
Principal Investigator: Karin Niedermann, MPH UniversitaetsSpital Zuerich
Principal Investigator: Heike Bischoff-Ferrari, Prof University of Zurich
  More Information

No publications provided

Responsible Party: Karin Niedermann, University of Zurich
ClinicalTrials.gov Identifier: NCT00913302     History of Changes
Other Study ID Numbers: 746
Study First Received: May 14, 2009
Last Updated: February 23, 2010
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Zurich:
Ankylosing Spondylitis
Education
Physical fitness

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 23, 2013