Ankylosing SpondylitisNCT03457285
Investigating the Use of Salaso to Improve Physiotherapy Management of Ankylosing Spondylitis (AS).
A study testing Physiotherapy in people with Ankylosing Spondylitis, run by St. James's Hospital, Ireland at 1 site in Ireland.
Trial summary
This is a pilot study to investigate the use of Salaso, a web based exercise app, to increase access to physiotherapy and improve physical activity in patients attending St James's Hospital Rheumatology for Ankylosing Spondylitis (AS). Participants will be set up on the app and given an individual exercise programme. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIreland
- Study dates
- 17 Oct 2018to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Ankylosing Spondylitis
Who cannot join
- Previous spinal surgery
- Spondylolisthesis
- Unwillingness to participate
- Unable to complete self-report questionnaires
- Progressive neurological deficit
- Neurological disease
- Cauda equina syndrome
- Unable to exercise on medical grounds
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Physiotherapy Department, Saint James's Hospital
Dublin
Ciarán Brennan, MSc, BSc
About this study
Official title: A Feasibility Study to Investigate the Use of Salaso to Increase Access to Physiotherapy and Increase Compliance to Exercise Prescription and Physical Activity in the Management of Ankylosing Spondylitis (AS).
This is a pilot study to investigate the use of Salaso, a web based exercise app, to increase access to physiotherapy and improve physical activity in patients attending St James's Hospital Rheumatology for Ankylosing Spondylitis (AS). Participants will be set up on the app and given an individual exercise programme. All individual exercises and exercise class videos will be available on the app. Completion of exercises can be logged on the app and exercise compliance will then be monitored remotely by the physiotherapist through the Salaso app. The physiotherapist will have a monthly telehealth session with each participant to assess progress and to address any difficulties. Outcome measures will be completed at initial assessment and again at the end of the pilot study. This data will then be analysed to assess the effectiveness of the Salaso app as a treatment option for AS.
Read the detailed description
AS is a chronic inflammatory condition affecting the spine and other joints, causing pain and stiffness. Currently approximately 150 people attend Saint James's Hospital rheumatology department for management of their condition. Physiotherapy plays a key role in this management. As this is often a younger patient population, it can be challenging for them to attend appointments due to work and family commitments. It is envisaged that this pilot will enhance treatment options for all participants.
The aims of this study are: to improve use of exercise and physical activity using an online exercise application; to improve self-management skills in monitoring progress and ability to exercise independently using an online exercise application; to provide an online appointment review option to patients who are unable to attend physiotherapy appointments in St James's Hospital.
Descriptive statistics will be used to record and analyse the study data, using SPSS software.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Physiotherapy
- Keywords
- Ankylosing spondylitis; physiotherapy; Salaso
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
Also called Salaso
Participants, with a confirmed diagnosis of AS, will be invited to participate. Once participants have provided informed consent, they will be required to complete the outcome measures provided. Participants will be set up to use the online exercise application and educated on its use.
Participants will then have access to videos of suitable exercises or exercise classes to follow and education material on their condition to read. Participants will be able to complete AS specific outcome measures and record their progress. Participants will also have a monthly video call with the senior rheumatology physiotherapist to discuss their exercise programme, symptoms and management. The participants will also record their compliance with their exercise programmes.
After the 6 month pilot period, participants will be required to complete the same outcome measures completed at the start of the study.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy via the Salaso Apllication Intervention | Experimental | All participants' physiotherapy- prescribed exercise programmes will be monitored via the Salaso application. Telehealth appointments will occur monthly and modifications to exercises will be made as required.
This will continue for the 6-month duration of the intervention. Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bath Ankylosing Spondylitis Metrology Index
Measure of spinal mobility
Measured: 6 months
Secondary outcomes (4)
Bath Ankylosing Spondylitis Disease Activity Index
Measuring disease activity in AS
Measured: 6 months
Bath Ankylosing Spondylitis Functional Index
Measuring functional activity in AS
Measured: 6 months
Arthritis Self-Efficacy Scale (ASES)
The scale is an assessment of a person's ability to self-manage his/her pain, function and other symptoms. The self-efficacy function scale has 9 questions, each scored on a scale of 1-10, with a total minimum score of 10 and a maximum score of 90. The self-efficacy pain scale has 5 questions, with a total minimum score of 5 and a maximum score of 50. The self-efficacy other symptoms scale has 6 questions, with a minimum total score of 6 and a maximum score of 60. The other symptoms scale and the pain scale may be combined, with a sum score given.
Measured: 6 months
Exercise Benefits/Barriers Scale (EBBS)
Measuring the perceived benefits of and barriers to performing the prescribed exercises. There are 43 questions in total. It may be scored in it's entirety or as two separate scales. Scores can range from 43 to 172. The higher the score, the more positively the individual perceives exercise. The benefits scale is scored between 29 and 116. The barriers scale is scored between 14 and 56. The higher the score on the barriers scale, the greater the perception of barriers to exercise. If combined, the barriers scale is reverse-scored.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start17 Oct 2018
- Primary completion17 Apr 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the same intervention
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. James's Hospital, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Salaso Health Solutions Limited, Novartis
- Responsible party
- Principal investigator, Ciaran Brennan, St. James's Hospital, Ireland
- Investigators
- Finbar O'Shea, Principal investigator, Consultant Rheumatologist, Saint James's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457285
- Sponsor's protocol ID
- SJH AS Salaso Study
- Status last verified
- Nov 2018
- First submitted
- 1 Feb 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Investigate the Use of Salaso to Increase Access to Physiotherapy and Increase Compliance to Exercise Prescription and Physical Activity in the Management of Ankylosing Spondylitis (AS).
- ClinicalTrials.gov ID
- NCT03457285
- Acronym / sponsor ID
- SJH AS Salaso Study
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing spondylitis; physiotherapy; Salaso
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- St. James's Hospital, IrelandUniversity, hospital or other
- Collaborators
- Salaso Health Solutions Limited, Novartis
- Study start
- 17 Oct 2018 (actual)
- Primary completion
- 17 Apr 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to investigate the use of Salaso, a web based exercise app, to increase access to physiotherapy and improve physical activity in patients attending St James's Hospital Rheumatology for Ankylosing Spondylitis (AS). Participants will be set up on the app and given an individual exercise programme. All individual exercises and exercise class videos will be available on the app. Completion of exercises can be logged on the app and exercise compliance will then be monitored remotely by the physiotherapist through the Salaso app. The physiotherapist will have a monthly telehealth session with each participant to assess progress and to address any difficulties. Outcome measures will be completed at initial assessment and again at the end of the pilot study. This data will then be analysed to assess the effectiveness of the Salaso app as a treatment option for AS.
Detailed description
AS is a chronic inflammatory condition affecting the spine and other joints, causing pain and stiffness. Currently approximately 150 people attend Saint James's Hospital rheumatology department for management of their condition. Physiotherapy plays a key role in this management. As this is often a younger patient population, it can be challenging for them to attend appointments due to work and family commitments. It is envisaged that this pilot will enhance treatment options for all participants.
The aims of this study are: to improve use of exercise and physical activity using an online exercise application; to improve self-management skills in monitoring progress and ability to exercise independently using an online exercise application; to provide an online appointment review option to patients who are unable to attend physiotherapy appointments in St James's Hospital.
Descriptive statistics will be used to record and analyse the study data, using SPSS software.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the same intervention
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy via the Salaso Apllication Intervention | Experimental | Other: PhysiotherapyAll participants' physiotherapy- prescribed exercise programmes will be monitored via the Salaso application. Telehealth appointments will occur monthly and modifications to exercises will be made as required. This will continue for the 6-month duration of the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed diagnosis of Ankylosing Spondylitis
Key exclusion criteria (8 listed)
- Previous spinal surgery
- Spondylolisthesis
- Unwillingness to participate
- Unable to complete self-report questionnaires
- Progressive neurological deficit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysiotherapyAlso: SalasoParticipants, with a confirmed diagnosis of AS, will be invited to participate. Once participants have provided informed consent, they will be required to complete the outcome measures provided. Participants will be set up to use the online exercise application and educated on its use. Participants will then have access to videos of suitable exercises or exercise classes to follow and education material on their condition to read. Participants will be able to complete AS specific outcome measures and record their progress. Participants will also have a monthly video call with the senior rheumatology physiotherapist to discuss their exercise programme, symptoms and management. The participants will also record their compliance with their exercise programmes. After the 6 month pilot period, participants will be required to complete the same outcome measures completed at the start of the study. | Other | Physiotherapy via the Salaso Apllication Intervention |
Primary outcome
Bath Ankylosing Spondylitis Metrology Index
Time frame: 6 months
Measure of spinal mobility
4 secondary outcomes
Bath Ankylosing Spondylitis Disease Activity Index
Time frame: 6 months
Bath Ankylosing Spondylitis Functional Index
Time frame: 6 months
Arthritis Self-Efficacy Scale (ASES)
Time frame: 6 months
Exercise Benefits/Barriers Scale (EBBS)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Finbar O'Shea principal investigator
Consultant Rheumatologist, Saint James's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Ankylosing Spondylitis, run by St. James's Hospital, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ciaran Brennan (0035314162503, cbrennan2@stjames.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bath Ankylosing Spondylitis Metrology Index (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.