NCT00913302

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2009

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

July 8, 2013

Status Verified

July 1, 2013

Enrollment Period

1.8 years

First QC Date

May 14, 2009

Last Update Submit

July 4, 2013

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing SpondylitisEducationPhysical fitness

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular Fitness

    Baseline and post-intervention

Study Arms (1)

Training

EXPERIMENTAL

cardiovascular training

Behavioral: Cardiovascular Training

Interventions

Cardiovascular TrainingBEHAVIORAL

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

Also known as: fitness, exercise
Training

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Chronic heart failure, functional NYHA Class III and IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Centre on Aging and Mobility

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 23836515DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Exercise

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Heike Bischoff Ferrari, MD, MPH

    University Hospital Zurich, Centre on Aging and Mobility

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2009

First Posted

June 4, 2009

Study Start

January 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2010

Last Updated

July 8, 2013

Record last verified: 2013-07

Locations

CH(1)