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

March 8, 2016 updated by: Tom O'Dwyer, University of Dublin, Trinity College

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, D8
        • Trinity Centre for Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brief Intervention Group
Participants in this intervention group will receive a twelve week 'Brief Intervention' delivered by a physiotherapist. Participants will have an initial consultation with a physiotherapist, followed by a number of follow-up sessions. The number and timing of follow-up sessions will be at the participant's discretion (a minimum of 3 and a maximum of 11 over the duration of the study). The follow-up sessions can be face-to-face, over the telephone, or video conferencing depending on participant preference. Participants may additionally opt-in for a weekly email or text message reminder of physical activity goals.
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.
No Intervention: Control Group
Participants in this control group will be asked to continue with their current levels of physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Free-living Physical Activity
Time Frame: up to 12 weeks follow-up
Actigraph monitor GT3X-BT worn during waking hours over 7 days.
up to 12 weeks follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: up to 12 weeks follow-up
up to 12 weeks follow-up
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: up to 12 weeks follow-up
up to 12 weeks follow-up
Bath Ankylosing Spondylitis Global score (BAS-G)
Time Frame: up to 12 weeks follow-up
up to 12 weeks follow-up
Ankylosing Spondylitis Quality of Life questionnaire (ASQoL)
Time Frame: up to 12 weeks follow-up
up to 12 weeks follow-up
Cardiorespiratory capacity
Time Frame: up to 12 weeks follow-up
VO2peak measured by submaximal, incremental treadmill test
up to 12 weeks follow-up
Body Composition
Time Frame: up to 12 weeks follow-up
Bioelectric impedance analysis & waist/hip circumference
up to 12 weeks follow-up
Flexibility
Time Frame: up to 12 weeks follow-up
Bath Ankylosing Spondylitis Metrology Index (BASMI) & Chest Expansion
up to 12 weeks follow-up
Muscular fitness
Time Frame: up to 12 weeks follow-up
Push-up test and curl-up test
up to 12 weeks follow-up
Exercise Barriers and Beliefs Scale (EBBS)
Time Frame: up to 12 weeks follow-up
up to 12 weeks follow-up
Arthritis self-efficacy questionnaire (Ankylosing Spondylitis version)
Time Frame: up to 12 weeks follow-up
up to 12 weeks follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dublin, Trinity College

Investigators

  • Principal Investigator: Finbar O'Shea, St. James's Hospital, Ireland
  • Principal Investigator: Fiona Wilson, University of Dublin, Trinity College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

February 23, 2015

First Submitted That Met QC Criteria

February 26, 2015

First Posted (Estimate)

February 27, 2015

Study Record Updates

Last Update Posted (Estimate)

March 9, 2016

Last Update Submitted That Met QC Criteria

March 8, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC2015/01/02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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