Increasing Physical Activity in Ankylosing Spondylitis: a Randomised Controlled Trial

Spondylitis, Ankylosing Clinical Trial

— INPACT-AS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374502
• Other study ID #: REC2015/01/02
• 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

• Spondylitis
• Spondylitis, Ankylosing

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