Ankylosing Spondylitis Clinical Trial
Official title:
WEB-Based Physiotherapy for People With Axial Spondyloarthritis: A Cohort Study
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | October 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | NHS Greater Glasgow and Clyde | Glasgow |
Lead Sponsor | Collaborator |
---|---|
Dr Lorna Paul | NHS Greater Glasgow and Clyde |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Functional Ability | 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). | One year | No |
Secondary | Level of Physical Activity | 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. | One year | No |
Secondary | Disease Activity | 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). | One Year | No |
Secondary | Spinal Mobility | 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). | One year | No |
Secondary | Employment and Productivity | 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 | One year | No |
Secondary | Health Status | 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 | One year | No |
Secondary | Attitude to exercise | 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. | one year | No |
Secondary | Personal motivation to exercise. | 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. | One year | No |
Secondary | Number of Interactions with Health professionals | the number of interactions with health care professionals such as GP visits will be documented throughout the study and any changes to medication noted. | over one year | No |
Secondary | Participant views on the website | 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. | One year | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02685904 -
A Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing Spondylitis
|
Phase 3 | |
Completed |
NCT02186873 -
A Study of Golimumab in Participants With Active Ankylosing Spondylitis
|
Phase 3 | |
Completed |
NCT01668004 -
The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012)
|
Phase 4 | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Completed |
NCT01934933 -
Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis
|
Phase 4 | |
Not yet recruiting |
NCT04875299 -
Optimal Adalimumab Plasma Concentrations in Ankylosing Spondylitis Patients
|
||
Completed |
NCT02758782 -
NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing Spondylitis
|
Phase 4 | |
Completed |
NCT02763111 -
Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of Various Doses of BCD-085 in Patients With Active Ankylosing Spondylitis
|
Phase 2 | |
Active, not recruiting |
NCT02687620 -
Does Immunogenicity Have an Influence on the Efficacy of Anti-TNF Therapy in Patients With AS: An Inception Cohort Study
|
||
Completed |
NCT02154425 -
A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
|
Phase 1 | |
Completed |
NCT01750528 -
Prevalence and Progression of Periodontitis in Ankylosing Spondylitis
|
N/A | |
Completed |
NCT01463189 -
Web-based Support to Manage Arthritis Pain
|
Phase 2 | |
Completed |
NCT01091675 -
Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis and Inadequate Response to ≥2 NSAIDs
|
Phase 3 | |
Completed |
NCT00844805 -
Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)
|
Phase 3 | |
Recruiting |
NCT00747578 -
Health-Related Quality of Life and Disease-Related Costs: Comparison Between Ankylosing Spondylitis, Rheumatoid Arthritis and Systemic Lupus Erythematosus in Taiwan
|
N/A | |
Completed |
NCT01083693 -
Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs
|
N/A | |
Completed |
NCT00715091 -
Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on RAdiographic Damage in Ankylosing Spondylitis
|
Phase 4 | |
Not yet recruiting |
NCT00517101 -
Presence of IBD Specific Antibodies (ASCA, ALCA, ACCA, AMCA) in the Sera of Patients With Spondyloarthropathy
|
N/A | |
Completed |
NCT00367211 -
Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.
|
Phase 3 | |
Completed |
NCT00133315 -
TNFalfa Blocking Treatment of Spondylarthropathies
|
Phase 4 |