Ankylosing SpondylitisNCT00913302
Effects of Cardiovascular Training in Individuals With Ankylosing Spondylitis
A study testing Cardiovascular Training in people with Ankylosing Spondylitis, run by University of Zurich at 1 site in Switzerland.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Cardiovascular Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2008to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Chronic heart failure, functional NYHA Class III and IV
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Centre on Aging and Mobility
Zurich, Canton of Zurich, 8091
About this study
Official title: Effects of Cardiovascular Training on Fitness, Cardiovascular Health, Bone Health and Quality of Life in Individuals With Ankylosing Spondylitis
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)
Read the 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.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Cardiovascular Training
- Keywords
- Ankylosing Spondylitis, Education, Physical fitness
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular TrainingBehavioural
Also called fitness, exercise
cardiovascular training, 3 times/week for 30-60 minutes, over 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | cardiovascular training Receives: Behavioral: Cardiovascular Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Fitness
Measured: Baseline and post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startJan 2008
- Primary completionNov 2009
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Ankylosing Spondylitis Association, Federal Office of Sports, Switzerland
- Responsible party
- Sponsor
- Investigators
- Heike Bischoff Ferrari, MD, MPH, Principal investigator, University Hospital Zurich, Centre on Aging and Mobility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913302
- Sponsor's protocol ID
- 746
- Status last verified
- Jul 2013
- First submitted
- 14 May 2009
- Last updated
- 8 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23836515
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cardiovascular Training on Fitness, Cardiovascular Health, Bone Health and Quality of Life in Individuals With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT00913302
- Acronym / sponsor ID
- 746
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing Spondylitis, Education, Physical fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss Ankylosing Spondylitis Association, Federal Office of Sports, Switzerland
- Study start
- Jan 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Behavioral: Cardiovascular Trainingcardiovascular training |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Chronic heart failure, functional NYHA Class III and IV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular TrainingAlso: fitness, exercisecardiovascular training, 3 times/week for 30-60 minutes, over 12 weeks | Behavioural | Training |
Primary outcome
Cardiovascular Fitness
Time frame: Baseline and post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2013.
- Derived from this study: PubMed 23836515Niedermann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heike Bischoff Ferrari, MD, MPH principal investigator
University Hospital Zurich, Centre on Aging and Mobility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovascular Training in people with Ankylosing Spondylitis, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Fitness (time frame: Baseline and post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00913302, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2013.