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WEB-Based Physiotherapy for People With Axial Spondyloarthritis

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ClinicalTrials.gov Identifier: NCT02666313
Recruitment Status : Unknown
Verified October 2016 by Dr Lorna Paul, University of Glasgow.
Recruitment status was:  Recruiting
First Posted : January 28, 2016
Last Update Posted : October 25, 2016
Sponsor:
Collaborator:
NHS Greater Glasgow and Clyde
Information provided by (Responsible Party):
Dr Lorna Paul, University of Glasgow

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.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Behavioral: Exercise Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: WEB-Based Physiotherapy for People With Axial Spondyloarthritis: A Cohort Study
Study Start Date : November 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017



Intervention Details:
  • Behavioral: Exercise

    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.



Primary Outcome Measures :
  1. Number of exercise sessions completed [ Time Frame: One year ]
    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.


Secondary Outcome Measures :
  1. Functional Ability [ Time Frame: One year ]
    Using the Bath ankylosing spondylitis index (BASFI) a validated self-reported 10 item questionnaire evaluating the ability to function and cope with activities of daily living over the past week. Each question is scored on a 100mm visual analogue scale from no limitations (0 mm) to very severe functional limitation (100 mm). Lower scores indicate better function, while higher scores indicate more functional disability. The Minimum Clinically Important Difference (MCID), which is the minimum level of change of an outcome measure that is considered to be clinically relevant, for BASFI is 7mm (Calin et al. 1994).

  2. Level of Physical Activity [ Time Frame: One year ]
    will be objectively measured for one week using an activPAL activity monitor. The device is attached to the participant's thigh using a waterproof dressing and is worn continuously during the monitoring period, including during bathing/showering and swimming. Participants will also be asked to keep an activity diary during this period. The device categorises the posture as either sedentary (seated or lying), standing or walking. In addition the number of steps per day is recorded (Grant et al., 2006). The activPAL will be fitted to the participant at each assessment and will be instructed to remove the device after one week and post it back to the research team in a stamped addressed envelope provided to them. We have used this method of returning the device in other studies to good effect.

  3. Disease Activity [ Time Frame: One Year ]
    Measured through the Bath Ankylosing spondylitis disease activity index, (BASDAI) which is a validated self-reported 6 item questionnaire measuring disease activity on a 100mm visual analogue scale, from none (0 mm) to very severe (100 mm). Items included in the BASDAI are severity of fatigue, spinal and peripheral joint pain, localised tenderness and morning stiffness over the past week. Lower scores indicate lower disease activity. The MCID for BASDAI is 10mm (scale 0-100mm) (Garrett et al. 1994).

  4. Spinal Mobility [ Time Frame: One year ]
    Measured through the Bath Ankylosing Spondylitis Metrology Index (BASMI), which comprises five clinical measurements of the posture and movement of the spine and provides a score out of 10 of the participant's limitation of movement due to their AS (Jenkinson et al. 1994).

  5. Employment and Productivity [ Time Frame: One year ]
    Assessed through the Work, Productivity and Activity Impairment (WPAI) questionnaire which is a validated 18 item, disease specific, self-reported measure of quality of life

  6. Health Status [ Time Frame: One year ]
    Health status will be measured using the EQ-5D which is a performance measure of functional exercise capacity and involves the measurement of the distance an individual is able to walk for a total of six minutes on a hard, flat surface (Balke, 1963). The participant is instructed to walk at a comfortable pace and to take rests as required. The 6MWT will be undertaken following the established protocol and the distance walked during the six minutes will be recorded. Although not specifically validated in axial SpA it is a well recognised outcome measure in a range of chronic conditions including OA

  7. Attitude to exercise [ Time Frame: one year ]
    Attitude to exercise will be measured using the Exercise Attitude Questionnaire-18 which is a means of evaluating participants' attitudes towards exercise. It has 18 questions which are scored by the participant. The EAQ will allow us to study how a participants' attitude affects their compliance. Participants may complete this independently, those who encounter reading/writing problems may be assisted by the assessor, however they will be unable to influence scores through discussion of question interpretation.

  8. Personal motivation to exercise. [ Time Frame: One year ]
    Personal motivation to exercise will be measured using the Exercise Motivations Inventory -2 (EMI-2). It is a 51-item, multidimensional instrument designed to test theoretically derived predictions concerning the influences of personal exercise participation. The principle components are stress management, weight management, recreation, social recognition, enjoyment, appearance, personal development, affliction, ill-health avoidance, competition and fitness and health pressures. Each question is rated on a scale of 0-5. Participants' may complete this independently, those who encounter reading/writing problems may be assisted by the assessor, however they will be unable to influence scores through discussion of question interpretation.

  9. Number of Interactions with Health professionals [ Time Frame: over one year ]
    the number of interactions with health care professionals such as GP visits will be documented throughout the study and any changes to medication noted.

  10. Participant views on the website [ Time Frame: One year ]
    Telephone interviews will be undertaken with 10 participants at 6 and 12 month assessments. A sample of maximum variation will be taken for these interviews, based on the compliance rates. The interviews will gather participants' views of the web-based physiotherapy programme in relation to factors affecting compliance with the intervention. The interviews will explore issues directly related to the programme itself such as ease of use, content, difficulties experienced and the amount/content of contact with the therapist. Interviews will also explore other barriers to compliance and possible solutions identified by participants.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02666313


Contacts
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Contact: Marie Therese McDonald, BsC 01413303734 M.McDonald@nhs.net
Contact: Sara Cameron 01413305925 Sara.Cameron@glasgow.ac.uk

Locations
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United Kingdom
NHS Greater Glasgow and Clyde Recruiting
Glasgow, United Kingdom, G51 4TF
Contact: Elaine Coulter, PhD    01413303249    Elaine.Coulter@glasgow.ac.uk   
Contact: Marie-Therese McDonald, BsC    01413303734    M.McDonald@nhs.net   
Sponsors and Collaborators
Dr Lorna Paul
NHS Greater Glasgow and Clyde
Investigators
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Study Chair: Lorna Paul, PHD University of Glasgow
Principal Investigator: Stefan Siebert, MD University of Glasgow

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Lorna Paul, Reader in Rehabilitation, University of Glasgow
ClinicalTrials.gov Identifier: NCT02666313     History of Changes
Other Study ID Numbers: WEBPASS
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Spondylarthritis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Ankylosis
Joint Diseases
Arthritis