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Clinical Trials/NCT02374502
NCT02374502
Completed
Not Applicable

Increasing Physical Activity in Ankylosing Spondylitis (INPACT-AS): a Randomised Controlled Trial

University of Dublin, Trinity College1 site in 1 country40 target enrollmentMarch 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spondylitis, Ankylosing
Sponsor
University of Dublin, Trinity College
Enrollment
40
Locations
1
Primary Endpoint
Free-living Physical Activity
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Ankylosing spondylitis is a chronic inflammatory condition that mostly affects the spine. This results in back pain and stiffness, and causes difficulty with daily activities. Physical activity and exercise are key components of the management of ankylosing spondylitis, however many adults with ankylosing spondylitis do not meet physical activity recommendations. This study aims to investigate the effects of a twelve week intervention designed to increase physical activity and exercise in adults with ankylosing spondylitis.

Detailed Description

Participants will be randomly allocated to one of two groups. An intervention group will receive individual consultations with a physiotherapist. The aim of the meetings will be to motivate and support participants on an individual basis, with the goal of increasing weekly physical activity. The second group, the control group, will continue with their current management strategies. All participants will be assessed at baseline, post-intervention (after twelve weeks) and after a three month follow-up period. The primary outcome measure will be free-living physical activity over one week.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
November 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tom O'Dwyer

Lead Investigator

University of Dublin, Trinity College

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of ankylosing spondylitis (diagnosed by a rheumatologist).
  • Able to read and understand the English language.
  • On stable pharmacological management.

Exclusion Criteria

  • Under 18 years of age, or over 64 years of age
  • Unable to read and understand the English language
  • Concomitant cardiac, respiratory or neurological condition
  • Co-morbidity restricting physical activity or inability to ambulate without a mobility aid
  • Acute lower limb injury
  • Uncontrolled epilepsy
  • Cognitive difficulties limiting ability to follow safety and protocol instructions
  • Change in medication (type of dosage) within six weeks of testing
  • On beta-blocker medication.

Outcomes

Primary Outcomes

Free-living Physical Activity

Time Frame: up to 12 weeks follow-up

Actigraph monitor GT3X-BT worn during waking hours over 7 days.

Secondary Outcomes

  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(up to 12 weeks follow-up)
  • Flexibility(up to 12 weeks follow-up)
  • Body Composition(up to 12 weeks follow-up)
  • Muscular fitness(up to 12 weeks follow-up)
  • Exercise Barriers and Beliefs Scale (EBBS)(up to 12 weeks follow-up)
  • Arthritis self-efficacy questionnaire (Ankylosing Spondylitis version)(up to 12 weeks follow-up)
  • Bath Ankylosing Spondylitis Functional Index (BASFI)(up to 12 weeks follow-up)
  • Ankylosing Spondylitis Quality of Life questionnaire (ASQoL)(up to 12 weeks follow-up)
  • Bath Ankylosing Spondylitis Global score (BAS-G)(up to 12 weeks follow-up)
  • Cardiorespiratory capacity(up to 12 weeks follow-up)

Study Sites (1)

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