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

Primary Purpose

Spondylitis, Ankylosing

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Brief Intervention
Sponsored by
University of Dublin, Trinity College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondylitis, Ankylosing focused on measuring Spondylarthropathies, Motor Activity, Physical Therapists, Accelerometry

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Trinity Centre for Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Brief Intervention Group

Control Group

Arm Description

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.

Participants in this control group will be asked to continue with their current levels of physical activity.

Outcomes

Primary Outcome Measures

Free-living Physical Activity
Actigraph monitor GT3X-BT worn during waking hours over 7 days.

Secondary Outcome Measures

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

Full Information

First Posted
February 23, 2015
Last Updated
March 8, 2016
Sponsor
University of Dublin, Trinity College
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1. Study Identification

Unique Protocol Identification Number
NCT02374502
Brief Title
Increasing Physical Activity in Ankylosing Spondylitis: a Randomised Controlled Trial
Acronym
INPACT-AS
Official Title
Increasing Physical Activity in Ankylosing Spondylitis (INPACT-AS): a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Dublin, Trinity College

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylitis, Ankylosing
Keywords
Spondylarthropathies, Motor Activity, Physical Therapists, Accelerometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants in this control group will be asked to continue with their current levels of physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Brief Intervention
Intervention Description
'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.
Primary Outcome Measure Information:
Title
Free-living Physical Activity
Description
Actigraph monitor GT3X-BT worn during waking hours over 7 days.
Time Frame
up to 12 weeks follow-up
Secondary Outcome Measure Information:
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame
up to 12 weeks follow-up
Title
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame
up to 12 weeks follow-up
Title
Bath Ankylosing Spondylitis Global score (BAS-G)
Time Frame
up to 12 weeks follow-up
Title
Ankylosing Spondylitis Quality of Life questionnaire (ASQoL)
Time Frame
up to 12 weeks follow-up
Title
Cardiorespiratory capacity
Description
VO2peak measured by submaximal, incremental treadmill test
Time Frame
up to 12 weeks follow-up
Title
Body Composition
Description
Bioelectric impedance analysis & waist/hip circumference
Time Frame
up to 12 weeks follow-up
Title
Flexibility
Description
Bath Ankylosing Spondylitis Metrology Index (BASMI) & Chest Expansion
Time Frame
up to 12 weeks follow-up
Title
Muscular fitness
Description
Push-up test and curl-up test
Time Frame
up to 12 weeks follow-up
Title
Exercise Barriers and Beliefs Scale (EBBS)
Time Frame
up to 12 weeks follow-up
Title
Arthritis self-efficacy questionnaire (Ankylosing Spondylitis version)
Time Frame
up to 12 weeks follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Finbar O'Shea
Organizational Affiliation
St. James's Hospital, Ireland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fiona Wilson
Organizational Affiliation
University of Dublin, Trinity College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trinity Centre for Health Sciences
City
Dublin
ZIP/Postal Code
D8
Country
Ireland

12. IPD Sharing Statement

Citations:
PubMed Identifier
27989730
Citation
O'Dwyer T, Monaghan A, Moran J, O'Shea F, Wilson F. Behaviour change intervention increases physical activity, spinal mobility and quality of life in adults with ankylosing spondylitis: a randomised trial. J Physiother. 2017 Jan;63(1):30-39. doi: 10.1016/j.jphys.2016.11.009. Epub 2016 Dec 8.
Results Reference
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Increasing Physical Activity in Ankylosing Spondylitis: a Randomised Controlled Trial

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