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

U

University of Dublin, Trinity College

Status

Completed

Conditions

Spondylitis, Ankylosing

Treatments

Behavioral: Brief Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02374502
REC2015/01/02

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Brief Intervention Group
Experimental group
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.
Treatment:
Behavioral: Brief Intervention
Control Group
No Intervention group
Description:
Participants in this control group will be asked to continue with their current levels of physical activity.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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