Skip to main content
OpenTrials
Completed

NCT Number: NCT02374502

Increasing Physical Activity in Ankylosing Spondylitis: 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spondylitis, Ankylosing Ankylosis Arthritis Axial Spondyloarthritis Behavior Bone Diseases Joint Diseases Motor Activity Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trinity Centre for Health Sciences

Dublin, D8, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brief intervention

Behavioral

'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 outcomes

  1. Free-living Physical Activity

    Time frame: up to 12 weeks follow-up

    Actigraph monitor GT3X-BT worn during waking hours over 7 days.

Secondary outcomes

  1. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Time frame: up to 12 weeks follow-up

  2. Bath Ankylosing Spondylitis Functional Index (BASFI)

    Time frame: up to 12 weeks follow-up

  3. Bath Ankylosing Spondylitis Global score (BAS-G)

    Time frame: up to 12 weeks follow-up

  4. Ankylosing Spondylitis Quality of Life questionnaire (ASQoL)

    Time frame: up to 12 weeks follow-up

  5. Cardiorespiratory capacity

    Time frame: up to 12 weeks follow-up

    VO2peak measured by submaximal, incremental treadmill test

  6. Body Composition

    Time frame: up to 12 weeks follow-up

    Bioelectric impedance analysis & waist/hip circumference

  7. Flexibility

    Time frame: up to 12 weeks follow-up

    Bath Ankylosing Spondylitis Metrology Index (BASMI) & Chest Expansion

  8. Muscular fitness

    Time frame: up to 12 weeks follow-up

    Push-up test and curl-up test

  9. Exercise Barriers and Beliefs Scale (EBBS)

    Time frame: up to 12 weeks follow-up

  10. Arthritis self-efficacy questionnaire (Ankylosing Spondylitis version)

    Time frame: up to 12 weeks follow-up

Sponsors and collaborators

Lead sponsor

University of Dublin, Trinity College

Other

Registry information

Official study title

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

Acronym: INPACT-AS

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 27, 2015
Registry last updated
Mar 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.