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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02374502
Other study ID # REC2015/01/02
Secondary ID
Status Completed
Phase N/A
First received February 23, 2015
Last updated March 8, 2016
Start date March 2015
Est. completion date November 2015

Study information

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

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Brief Intervention
'Brief Intervention' is the term used to mean verbal advice, discussion, negotiation or encouragement, with or without written or other support or follow-up. 'Brief Interventions' provide a structured way to deliver advice and involve the provision of formal help and follow-up. They aim to equip people with tools to change attitudes and handle underlying problems.

Locations

Country Name City State
Ireland Trinity Centre for Health Sciences Dublin

Sponsors (1)

Lead Sponsor Collaborator
University of Dublin, Trinity College

Country where clinical trial is conducted

Ireland, 

Outcome

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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