Effects of Cardiovascular Training in Individuals With Ankylosing Spondylitis
Primary Purpose
Ankylosing Spondylitis
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Cardiovascular Training
Sponsored by
About this trial
This is an interventional supportive care trial for Ankylosing Spondylitis focused on measuring Ankylosing Spondylitis, Education, Physical fitness
Eligibility 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
Sites / Locations
- University Hospital Zurich, Centre on Aging and Mobility
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Training
Arm Description
cardiovascular training
Outcomes
Primary Outcome Measures
Cardiovascular Fitness
Secondary Outcome Measures
Full Information
NCT ID
NCT00913302
First Posted
May 14, 2009
Last Updated
July 4, 2013
Sponsor
University of Zurich
Collaborators
Swiss Ankylosing Spondylitis Association, Federal Office of Sports, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT00913302
Brief Title
Effects of Cardiovascular Training in Individuals With Ankylosing Spondylitis
Official Title
Effects of Cardiovascular Training on Fitness, Cardiovascular Health, Bone Health and Quality of Life in Individuals With Ankylosing Spondylitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Swiss Ankylosing Spondylitis Association, Federal Office of Sports, Switzerland
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
Ankylosing Spondylitis, Education, Physical fitness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training
Arm Type
Experimental
Arm Description
cardiovascular training
Intervention Type
Behavioral
Intervention Name(s)
Cardiovascular Training
Other Intervention Name(s)
fitness, exercise
Intervention Description
cardiovascular training, 3 times/week for 30-60 minutes, over 12 weeks
Primary Outcome Measure Information:
Title
Cardiovascular Fitness
Time Frame
Baseline and post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heike Bischoff Ferrari, MD, MPH
Organizational Affiliation
University Hospital Zurich, Centre on Aging and Mobility
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Centre on Aging and Mobility
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
23836515
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Cardiovascular Training in Individuals With Ankylosing Spondylitis
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