NCT02666313

Brief Summary

Regular exercise is a core component of the long-term management of people with axial spondyloarthritis (axial SpA). However, delivering long-term exercise programmes is unrealistic and unsustainable using traditional NHS services. Web-based physiotherapy, has been developed, a possible alternative service model to support people with axial SpA to exercise regularly however long-term compliance to the programme (12 months) needs to be established. The aim of this prospective cohort study is to assess the feasibility, sustainability and acceptability of a 12 month individualised web-based physiotherapy programme in people with axial SpA. Fifty people with established axial SpA, will receive 12 months of individualised, remotely monitored, web-based physiotherapy. The primary outcome will be four weekly compliance rates with the programme over the 12 month period. Secondary outcomes (baseline, 6 and 12 months) will include function, disease activity, spinal mobility, quality of life, attitudes and motivations towards exercise, fitness, health status, employment, physical activity. The number of interactions with health care professionals and changes in medication will be documented. A subsample of the cohort will be interviewed at 6 and 12 months to gather participants' views of the web-based physiotherapy programme and factors influencing compliance with the programme.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

1.9 years

First QC Date

January 20, 2016

Last Update Submit

October 24, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of exercise sessions completed

    based on the number of times the participants complete their exercise diary each week; as recorded on the website. The physiotherapist will record the number of completed exercise sessions each week and, from this, the mean number of sessions completed every four weeks will be calculated. Compliance will be analysed for each four-week period and for each 3-month period.

    One year

Secondary Outcomes (10)

  • Functional Ability

    One year

  • Level of Physical Activity

    One year

  • Disease Activity

    One Year

  • Spinal Mobility

    One year

  • Employment and Productivity

    One year

  • +5 more secondary outcomes

Interventions

ExerciseBEHAVIORAL

The physiotherapist will select exercises which are appropriate to that participant. Participants will complete online exercise diaries which are reviewed remotely by the physiotherapist. Depending on progress, exercises can be progressed, added or removed from the patient's individualised programme. Participants will be encouraged to undertake their exercise programme, according to evidence base guidelines, five days/week for 30 minutes/day. Participants will receive weekly phone calls for the first two weeks of the programme. Thereafter, every two weeks the physiotherapist will review the exercise diary of each participant and remotely alter the participant's exercise programme as appropriate, by changing any combination of exercises, level of difficulty or number of repetitions.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of axial SpA (made by a Rheumatology consultant and fulfilling the ASAS criteria) (Rudwaleit et al. 2009)
  • Under the care of a Rheumatology consultant in NHS Greater Glasgow and Clyde
  • Minimum of 1 year since diagnosis
  • Access to a personal computer/tablet or smart television with an email address and internet connection
  • Over 18 years old
  • A good understanding of English language

You may not qualify if:

  • Have had joint replacement surgery or spinal surgery within the last 6 months
  • Other significant co-morbidity which would preclude taking part in a regular exercise programme
  • Currently taking part in regular exercise (three times per week or more) and/or a regular physiotherapy programme
  • Currently participating in another clinical trial (rehabilitation or pharmacological)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Greater Glasgow and Clyde

Glasgow, G51 4TF, United Kingdom

RECRUITING

Related Publications (1)

  • Paul L, Coulter EH, Cameron S, McDonald MT, Brandon M, Cook D, McConnachie A, Siebert S. Web-based physiotherapy for people with axial spondyloarthritis (WEBPASS) - a study protocol. BMC Musculoskelet Disord. 2016 Aug 24;17(1):360. doi: 10.1186/s12891-016-1218-1.

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Exercise

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Lorna Paul, PHD

    University of Glasgow

    STUDY CHAIR
  • Stefan Siebert, MD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Therese McDonald, BsC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Reader in Rehabilitation

Study Record Dates

First Submitted

January 20, 2016

First Posted

January 28, 2016

Study Start

November 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations