Spondylitis, Ankylosing Clinical Trial
— INPACT-ASOfficial title:
Increasing Physical Activity in Ankylosing Spondylitis (INPACT-AS): a Randomised Controlled Trial
Verified date | March 2016 |
Source | University of Dublin, Trinity College |
Contact | n/a |
Is FDA regulated | No |
Health authority | Ireland: Research Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | November 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 64 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Ireland | Trinity Centre for Health Sciences | Dublin |
Lead Sponsor | Collaborator |
---|---|
University of Dublin, Trinity College |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Free-living Physical Activity | Actigraph monitor GT3X-BT worn during waking hours over 7 days. | up to 12 weeks follow-up | No |
Secondary | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | up to 12 weeks follow-up | No | |
Secondary | Bath Ankylosing Spondylitis Functional Index (BASFI) | up to 12 weeks follow-up | No | |
Secondary | Bath Ankylosing Spondylitis Global score (BAS-G) | up to 12 weeks follow-up | No | |
Secondary | Ankylosing Spondylitis Quality of Life questionnaire (ASQoL) | up to 12 weeks follow-up | No | |
Secondary | Cardiorespiratory capacity | VO2peak measured by submaximal, incremental treadmill test | up to 12 weeks follow-up | No |
Secondary | Body Composition | Bioelectric impedance analysis & waist/hip circumference | up to 12 weeks follow-up | No |
Secondary | Flexibility | Bath Ankylosing Spondylitis Metrology Index (BASMI) & Chest Expansion | up to 12 weeks follow-up | No |
Secondary | Muscular fitness | Push-up test and curl-up test | up to 12 weeks follow-up | No |
Secondary | Exercise Barriers and Beliefs Scale (EBBS) | up to 12 weeks follow-up | No | |
Secondary | Arthritis self-efficacy questionnaire (Ankylosing Spondylitis version) | up to 12 weeks follow-up | No |
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