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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 April 2016 |
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Main ID: |
NCT02374502 |
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Date of registration:
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23/02/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Increasing Physical Activity in Ankylosing Spondylitis: a Randomised Controlled Trial
INPACT-AS |
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Scientific title:
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Increasing Physical Activity in Ankylosing Spondylitis (INPACT-AS): a Randomised Controlled Trial |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02374502 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Ireland
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Contacts
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Name:
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Fiona Wilson |
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Address:
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Telephone:
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Email:
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Affiliation:
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Trinity College Dublin |
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Name:
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Finbar O'Shea |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. James's Hospital, Dublin |
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Key inclusion & exclusion criteria
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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
- Pregnant
- Change in medication (type of dosage) within six weeks of testing
- On beta-blocker medication.
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Spondylitis, Ankylosing
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Intervention(s)
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Behavioral: Brief Intervention
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Primary Outcome(s)
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Free-living Physical Activity
[Time Frame: up to 12 weeks follow-up]
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Secondary Outcome(s)
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Bath Ankylosing Spondylitis Global score (BAS-G)
[Time Frame: up to 12 weeks follow-up]
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Bath Ankylosing Spondylitis Functional Index (BASFI)
[Time Frame: up to 12 weeks follow-up]
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Exercise Barriers and Beliefs Scale (EBBS)
[Time Frame: up to 12 weeks follow-up]
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Arthritis self-efficacy questionnaire (Ankylosing Spondylitis version)
[Time Frame: up to 12 weeks follow-up]
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Body Composition
[Time Frame: up to 12 weeks follow-up]
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Cardiorespiratory capacity
[Time Frame: up to 12 weeks follow-up]
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Muscular fitness
[Time Frame: up to 12 weeks follow-up]
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Ankylosing Spondylitis Quality of Life questionnaire (ASQoL)
[Time Frame: up to 12 weeks follow-up]
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Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
[Time Frame: up to 12 weeks follow-up]
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Flexibility
[Time Frame: up to 12 weeks follow-up]
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Secondary ID(s)
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REC2015/01/02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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