Clinical trial NCT00913302: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing Spondylitis
Education
Physical fitness
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss Ankylosing Spondylitis Association
name: Federal Office of Sports, Switzerland
First posted: 2009-06-04
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 The efficacy of mobility exercise was confirmed by the third update (2007, unpublished) of the Cochrane review regarding Physiotherapy in AS.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.

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

Primary outcomes:
measure: Cardiovascular Fitness
timeFrame: Baseline and post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Centre on Aging and Mobility
state: ZH
Study officials:
affiliation: University Hospital Zurich, Centre on Aging and Mobility
name: Heike Bischoff Ferrari, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.