Axial SpondyloarthritisNCT05504616
Health Technology to Improve Exercise in axSpA
A study testing Health technology-based intervention strategy in people with Axial Spondyloarthritis, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Despite the known benefits of physical activity, the majority of Canadians fail to meet recommended guidelines. Patients with axial spondyloarthritis (axSpA) also fail to meet recommended guidelines. Exercise, a critical component of physical activity, is considered the cornerstone of axSpA management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- Health technology-based intervention strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jul 2022to 31 Dec 2024
- 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
- Adults (aged 18 and older) with a diagnosis of axSpA based on ASAS criteria
- Have access to email and a smart phone device (Android or iOS operating systems)
- Enrolled in the SPARCC Research Program
- Passes pre-participation health screen
Who cannot join
- Non-English speaking
- Not enrolled in the SPARCC Research Program
- Comorbidities or physical impairments that may preclude physical activity (e.g., symptomatic cardiovascular disease; wheelchair bound etc.)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University Health Network - Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Tina Ko, tina.ko@uhn.ca
About this study
Official title: Physical Activity in Axial Spondyloarthritis: Development and Implementation of an Evidence-Based Health Technology Approach to Improve Adherence to Recommended Guidelines
Despite the known benefits of physical activity, the majority of Canadians fail to meet recommended guidelines. Patients with axial spondyloarthritis (axSpA) also fail to meet recommended guidelines. Exercise, a critical component of physical activity, is considered the cornerstone of axSpA management. Simple health technologies such as mobile phone messaging and email can be useful tools to increase engagement in regular physical activity among the general public and patients with chronic disease. As such, the aim of this research project is to develop and test a patient-centered strategy that provides education on the importance of physical activity and utilizes existing health technologies (such as smart phone applications) to encourage regular participation in physical activity. The results of this study are expected to demonstrate that patients with axSpA will increase their daily engagement in physical activity, and therefore improve symptoms, function and overall quality of life.
- Conditions
- Axial Spondyloarthritis
- Being tested
- Health technology-based intervention strategy
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health technology-based intervention strategyOther
Patient-centered, technology-based intervention strategy aimed at increasing physical activity in patients with axSpA
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants randomized to the intervention group will receive an initial electronic communication (i.e. email) that includes:
* Link to physical activity education. This will be an educational module based on Phase 1 results and evidence-based literature regarding the benefits of physical activity in the general population and specific to axSpA.
* One week after receiving the physical activity educational module, participants will receive access to the ADAS application and an .ics file for each 3-week cycle of electronic calendar reminders to engage in physical activity. Receives: Other: Health technology-based intervention strategy |
| Control Group | No intervention | Participants randomized to the control group will receive usual care, which includes standard rheumatology care and access to educational materials on the importance of exercise and physical activity available through the TWH Spondylitis Program and through the public domain. They will receive a link to the physical activity educational module at baseline. They also have access to the program physiotherapist for a single one-hour individualized exercise consultation as requested by either the patient or the treating rheumatologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in levels of physical activity as measured by the International Physical Activity Questionnaire-Short Form questionnaire (IPAQ-SF)
The IPAQ-SF is a self-report questionnaire designed to estimate total physical activity in MET-min/week by assessing the types of intensity of physical activity and sitting time that people do as part of their daily lives.
Measured: Assessed electronically by an e-survey platform at baseline, 3, 6, 9 and 12 weeks in the intervention and control groups.
Changes in exercise behaviour as measured by an adapted Stanford Exercise Behaviours Questionnaire
2-item questionnaire measuring total time (minutes) spent on stretching and strengthening exercises each week.
Measured: Assessed electronically by an e-survey platform at baseline, 3, 6, 9 and 12 weeks in the intervention and control groups.
Change in levels of physical activity as measured by Accelerometry
Participants wear an accelerometer for 7 consecutive days at baseline and again at 12 weeks. The participant will mail back the activity monitor using a pre-paid envelope following each seven-day period.
Measured: Assessed at baseline and at 12 weeks.
Change in perceived benefits and barriers to exercise as a result of the technology-based intervention strategy as measured by the Exercise Benefits/Barriers Scale (EBBS)
The EBBS measures perceptions regarding the benefits of, and barriers to, exercise.
Measured: Assessed at baseline and at 12 weeks.
Change in functioning and health as a result of the technology-based intervention strategy as measured by the ASAS Health Index
The self-report questionnaire measures functioning and health across 17 aspects of health and 9 environmental factors in patients with spondyloarthritis. The items measure the concept of 'functioning, disability and health'
Measured: Assessed at baseline and at 12 weeks.
Secondary outcomes (7)
Change in disease activity over the course of 12 weeks as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDI) questionnaire
Disease activity, including pain, fatigue and stiffness as measured by the BASDAI questionnaire (a 0 - 10 visual analog scale) weekly.
Measured: From baseline, assessed up to 12 weeks.
Change in function over the course of 12 weeks as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) questionnaire
Function as measured by the BASFI questionnaire (0 - 10 visual analog scale) weekly.
Measured: From baseline, assessed up to 12 weeks.
Number of accepted invites over the course of 12 weeks
Acceptance of planned exercise, as measured by uptake of health technology-based intervention strategy
Measured: From baseline, assessed up to 12 weeks.
Frequency of physical activity sessions as a result of the technology-based intervention strategy over the course of 12 weeks
Acceptance of planned exercise, as measured by uptake of health technology-based intervention strategy
Measured: From baseline, assessed up to 12 weeks.
Duration of physical activity sessions as a result of the technology-based intervention strategy over the course of 12 weeks
Acceptance of planned exercise, as measured by uptake of health technology-based intervention strategy
Measured: From baseline, assessed up to 12 weeks.
Acceptance of health technology-based intervention strategy, as measured by the Mobile Application Rating Scale
Acceptance of intervention, as measured by the Mobile Application Rating Scale. MARS is a 5-point scale from 1-inadequate or strongly disagree to 5-excellent or strongly agree that accesses app quality, app subjective quality, and perceived impact of the app on user's knowledge, intentions to change as well as the likelihood of actual change in the target health behaviour. Higher scores indicate greater quality and acceptance of the intervention.
Measured: Assessed at 12 weeks.
Number of enrolled participants who complete the study
Adherence, as measured by the rate of study completion.
Measured: Assessed at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start21 Jul 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Repeated measures randomized control pre-test/post-test design comparing an intervention group with a control group (usual care).
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Initiative for Outcomes in Rheumatology Care
- Responsible party
- Principal investigator, Laura Passalent, University Health Network, Toronto
- Investigators
- Laura Passalent, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504616
- Sponsor's protocol ID
- 19-5919
- Status last verified
- Nov 2022
- First submitted
- 29 Jul 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. World Health Organization. Fact Sheet Updated February 2018. Available at: http://www.who.int/mediacentre/factsheets/fs385/en/ Accessed on March 26, 2018
Canadian Society for Exercise Physiology. Canadian physical activity guidelines. 2011. Available at http://www.csep.ca/CMFiles/Guidelines/CanadianPhysicalActivityGuidelinesStatements_E%203.pdf. Accessed on March 29, 2018
World Health Organization. Physical activity. Available at: http://www.who.int/topics/physical_activity/en/ Accessed on March 29, 2018
Sieper J, Rudwaleit M, Baraliakos X, Brandt J, Braun J, Burgos-Vargas R, Dougados M, Hermann KG, Landewe R, Maksymowych W, van der Heijde D. The Assessment of SpondyloArthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis. Ann Rheum Dis. 2009 Jun;68 Suppl 2:ii1-44. doi: 10.1136/ard.2008.104018.
PubMed 19433414Dagfinrud H, Kvien TK, Hagen KB. Physiotherapy interventions for ankylosing spondylitis. Cochrane Database Syst Rev. 2008 Jan 23;2008(1):CD002822. doi: 10.1002/14651858.CD002822.pub3.
PubMed 18254008van der Heijde D, Ramiro S, Landewe R, Baraliakos X, Van den Bosch F, Sepriano A, Regel A, Ciurea A, Dagfinrud H, Dougados M, van Gaalen F, Geher P, van der Horst-Bruinsma I, Inman RD, Jongkees M, Kiltz U, Kvien TK, Machado PM, Marzo-Ortega H, Molto A, Navarro-Compan V, Ozgocmen S, Pimentel-Santos FM, Reveille J, Rudwaleit M, Sieper J, Sampaio-Barros P, Wiek D, Braun J. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017 Jun;76(6):978-991. doi: 10.1136/annrheumdis-2016-210770. Epub 2017 Jan 13.
PubMed 28087505Ward MM, Deodhar A, Akl EA, Lui A, Ermann J, Gensler LS, Smith JA, Borenstein D, Hiratzka J, Weiss PF, Inman RD, Majithia V, Haroon N, Maksymowych WP, Joyce J, Clark BM, Colbert RA, Figgie MP, Hallegua DS, Prete PE, Rosenbaum JT, Stebulis JA, van den Bosch F, Yu DT, Miller AS, Reveille JD, Caplan L. American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2016 Feb;68(2):282-98. doi: 10.1002/art.39298. Epub 2015 Sep 24.
PubMed 26401991Rausch Osthoff AK, Niedermann K, Braun J, Adams J, Brodin N, Dagfinrud H, Duruoz T, Esbensen BA, Gunther KP, Hurkmans E, Juhl CB, Kennedy N, Kiltz U, Knittle K, Nurmohamed M, Pais S, Severijns G, Swinnen TW, Pitsillidou IA, Warburton L, Yankov Z, Vliet Vlieland TPM. 2018 EULAR recommendations for physical activity in people with inflammatory arthritis and osteoarthritis. Ann Rheum Dis. 2018 Sep;77(9):1251-1260. doi: 10.1136/annrheumdis-2018-213585. Epub 2018 Jul 11.
PubMed 29997112Haroon NN, Paterson JM, Li P, Inman RD, Haroon N. Patients With Ankylosing Spondylitis Have Increased Cardiovascular and Cerebrovascular Mortality: A Population-Based Study. Ann Intern Med. 2015 Sep 15;163(6):409-16. doi: 10.7326/M14-2470.
PubMed 26258401Klingberg E, Lorentzon M, Mellstrom D, Geijer M, Gothlin J, Hilme E, Hedberg M, Carlsten H, Forsblad-d'Elia H. Osteoporosis in ankylosing spondylitis - prevalence, risk factors and methods of assessment. Arthritis Res Ther. 2012 May 8;14(3):R108. doi: 10.1186/ar3833.
PubMed 22569245Feldtkeller E, Vosse D, Geusens P, van der Linden S. Prevalence and annual incidence of vertebral fractures in patients with ankylosing spondylitis. Rheumatol Int. 2006 Jan;26(3):234-9. doi: 10.1007/s00296-004-0556-8. Epub 2005 Mar 11.
PubMed 15761730Dursun N, Sarkaya S, Ozdolap S, Dursun E, Zateri C, Altan L, Birtane M, Akgun K, Revzani A, Aktas I, Tastekin N, Celiker R. Risk of falls in patients with ankylosing spondylitis. J Clin Rheumatol. 2015 Mar;21(2):76-80. doi: 10.1097/RHU.0000000000000216.
PubMed 25710858Passalent LA, Soever LJ, O'Shea FD, Inman RD. Exercise in ankylosing spondylitis: discrepancies between recommendations and reality. J Rheumatol. 2010 Apr;37(4):835-41. doi: 10.3899/jrheum.090655. Epub 2010 Mar 1.
PubMed 20194443Arturi P, Schneeberger EE, Sommerfleck F, Buschiazzo E, Ledesma C, Maldonado Cocco JA, Citera G. Adherence to treatment in patients with ankylosing spondylitis. Clin Rheumatol. 2013 Jul;32(7):1007-15. doi: 10.1007/s10067-013-2221-7. Epub 2013 Mar 21.
PubMed 23515597Swinnen TW, Scheers T, Lefevre J, Dankaerts W, Westhovens R, de Vlam K. Physical activity assessment in patients with axial spondyloarthritis compared to healthy controls: a technology-based approach. PLoS One. 2014 Feb 28;9(2):e85309. doi: 10.1371/journal.pone.0085309. eCollection 2014.
PubMed 24586239
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity in Axial Spondyloarthritis: Development and Implementation of an Evidence-Based Health Technology Approach to Improve Adherence to Recommended Guidelines
- ClinicalTrials.gov ID
- NCT05504616
- Acronym / sponsor ID
- 19-5919
- Conditions
- Axial Spondyloarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Initiative for Outcomes in Rheumatology Care
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Aug 2022 (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.
Despite the known benefits of physical activity, the majority of Canadians fail to meet recommended guidelines. Patients with axial spondyloarthritis (axSpA) also fail to meet recommended guidelines. Exercise, a critical component of physical activity, is considered the cornerstone of axSpA management. Simple health technologies such as mobile phone messaging and email can be useful tools to increase engagement in regular physical activity among the general public and patients with chronic disease. As such, the aim of this research project is to develop and test a patient-centered strategy that provides education on the importance of physical activity and utilizes existing health technologies (such as smart phone applications) to encourage regular participation in physical activity. The results of this study are expected to demonstrate that patients with axSpA will increase their daily engagement in physical activity, and therefore improve symptoms, function and overall quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Repeated measures randomized control pre-test/post-test design comparing an intervention group with a control group (usual care).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Health technology-based intervention strategyParticipants randomized to the intervention group will receive an initial electronic communication (i.e. email) that includes: * Link to physical activity education. This will be an educational module based on Phase 1 results and evidence-based literature regarding the benefits of physical activity in the general population and specific to axSpA. * One week after receiving the physical activity educational module, participants will receive access to the ADAS application and an .ics file for each 3-week cycle of electronic calendar reminders to engage in physical activity. |
| Control Group | No intervention | –Participants randomized to the control group will receive usual care, which includes standard rheumatology care and access to educational materials on the importance of exercise and physical activity available through the TWH Spondylitis Program and through the public domain. They will receive a link to the physical activity educational module at baseline. They also have access to the program physiotherapist for a single one-hour individualized exercise consultation as requested by either the patient or the treating rheumatologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (aged 18 and older) with a diagnosis of axSpA based on ASAS criteria
- Have access to email and a smart phone device (Android or iOS operating systems)
- Enrolled in the SPARCC Research Program
- Passes pre-participation health screen
Key exclusion criteria (3 listed)
- Non-English speaking
- Not enrolled in the SPARCC Research Program
- Comorbidities or physical impairments that may preclude physical activity (e.g., symptomatic cardiovascular disease; wheelchair bound etc.)
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 |
|---|---|---|
| Health technology-based intervention strategyPatient-centered, technology-based intervention strategy aimed at increasing physical activity in patients with axSpA | Other | Intervention Group |
Primary outcome
Changes in levels of physical activity as measured by the International Physical Activity Questionnaire-Short Form questionnaire (IPAQ-SF)
Time frame: Assessed electronically by an e-survey platform at baseline, 3, 6, 9 and 12 weeks in the intervention and control groups.
The IPAQ-SF is a self-report questionnaire designed to estimate total physical activity in MET-min/week by assessing the types of intensity of physical activity and sitting time that people do as part of their daily lives.
Changes in exercise behaviour as measured by an adapted Stanford Exercise Behaviours Questionnaire
Time frame: Assessed electronically by an e-survey platform at baseline, 3, 6, 9 and 12 weeks in the intervention and control groups.
2-item questionnaire measuring total time (minutes) spent on stretching and strengthening exercises each week.
Change in levels of physical activity as measured by Accelerometry
Time frame: Assessed at baseline and at 12 weeks.
Participants wear an accelerometer for 7 consecutive days at baseline and again at 12 weeks. The participant will mail back the activity monitor using a pre-paid envelope following each seven-day period.
Change in perceived benefits and barriers to exercise as a result of the technology-based intervention strategy as measured by the Exercise Benefits/Barriers Scale (EBBS)
Time frame: Assessed at baseline and at 12 weeks.
The EBBS measures perceptions regarding the benefits of, and barriers to, exercise.
Change in functioning and health as a result of the technology-based intervention strategy as measured by the ASAS Health Index
Time frame: Assessed at baseline and at 12 weeks.
The self-report questionnaire measures functioning and health across 17 aspects of health and 9 environmental factors in patients with spondyloarthritis. The items measure the concept of 'functioning, disability and health'
7 secondary outcomes
Change in disease activity over the course of 12 weeks as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDI) questionnaire
Time frame: From baseline, assessed up to 12 weeks.
Change in function over the course of 12 weeks as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) questionnaire
Time frame: From baseline, assessed up to 12 weeks.
Number of accepted invites over the course of 12 weeks
Time frame: From baseline, assessed up to 12 weeks.
Frequency of physical activity sessions as a result of the technology-based intervention strategy over the course of 12 weeks
Time frame: From baseline, assessed up to 12 weeks.
Duration of physical activity sessions as a result of the technology-based intervention strategy over the course of 12 weeks
Time frame: From baseline, assessed up to 12 weeks.
Acceptance of health technology-based intervention strategy, as measured by the Mobile Application Rating Scale
Time frame: Assessed at 12 weeks.
Number of enrolled participants who complete the study
Time frame: Assessed at 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Background1. World Health Organization. Fact Sheet Updated February 2018. Available at: http://www.who.int/mediacentre/factsheets/fs385/en/ Accessed on March 26, 2018
- BackgroundCanadian Society for Exercise Physiology. Canadian physical activity guidelines. 2011. Available at http://www.csep.ca/CMFiles/Guidelines/CanadianPhysicalActivityGuidelinesStatements_E%203.pdf. Accessed on March 29, 2018
- BackgroundWorld Health Organization. Physical activity. Available at: http://www.who.int/topics/physical_activity/en/ Accessed on March 29, 2018
- Background: PubMed 19433414Sieper J, Rudwaleit M, Baraliakos X, Brandt J, Braun J, Burgos-Vargas R, Dougados M, Hermann KG, Landewe R, Maksymowych W, van der Heijde D. The Assessment of SpondyloArthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis. Ann Rheum Dis. 2009 Jun;68 Suppl 2:ii1-44. doi: 10.1136/ard.2008.104018.
- Background: PubMed 18254008Dagfinrud H, Kvien TK, Hagen KB. Physiotherapy interventions for ankylosing spondylitis. Cochrane Database Syst Rev. 2008 Jan 23;2008(1):CD002822. doi: 10.1002/14651858.CD002822.pub3.
- Background: PubMed 28087505van der Heijde D, Ramiro S, Landewe R, Baraliakos X, Van den Bosch F, Sepriano A, Regel A, Ciurea A, Dagfinrud H, Dougados M, van Gaalen F, Geher P, van der Horst-Bruinsma I, Inman RD, Jongkees M, Kiltz U, Kvien TK, Machado PM, Marzo-Ortega H, Molto A, Navarro-Compan V, Ozgocmen S, Pimentel-Santos FM, Reveille J, Rudwaleit M, Sieper J, Sampaio-Barros P, Wiek D, Braun J. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017 Jun;76(6):978-991. doi: 10.1136/annrheumdis-2016-210770. Epub 2017 Jan 13.
- Background: PubMed 26401991Ward MM, Deodhar A, Akl EA, Lui A, Ermann J, Gensler LS, Smith JA, Borenstein D, Hiratzka J, Weiss PF, Inman RD, Majithia V, Haroon N, Maksymowych WP, Joyce J, Clark BM, Colbert RA, Figgie MP, Hallegua DS, Prete PE, Rosenbaum JT, Stebulis JA, van den Bosch F, Yu DT, Miller AS, Reveille JD, Caplan L. American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2016 Feb;68(2):282-98. doi: 10.1002/art.39298. Epub 2015 Sep 24.
- Background: PubMed 29997112Rausch Osthoff AK, Niedermann K, Braun J, Adams J, Brodin N, Dagfinrud H, Duruoz T, Esbensen BA, Gunther KP, Hurkmans E, Juhl CB, Kennedy N, Kiltz U, Knittle K, Nurmohamed M, Pais S, Severijns G, Swinnen TW, Pitsillidou IA, Warburton L, Yankov Z, Vliet Vlieland TPM. 2018 EULAR recommendations for physical activity in people with inflammatory arthritis and osteoarthritis. Ann Rheum Dis. 2018 Sep;77(9):1251-1260. doi: 10.1136/annrheumdis-2018-213585. Epub 2018 Jul 11.
- Background: PubMed 26258401Haroon NN, Paterson JM, Li P, Inman RD, Haroon N. Patients With Ankylosing Spondylitis Have Increased Cardiovascular and Cerebrovascular Mortality: A Population-Based Study. Ann Intern Med. 2015 Sep 15;163(6):409-16. doi: 10.7326/M14-2470.
- Background: PubMed 22569245Klingberg E, Lorentzon M, Mellstrom D, Geijer M, Gothlin J, Hilme E, Hedberg M, Carlsten H, Forsblad-d'Elia H. Osteoporosis in ankylosing spondylitis - prevalence, risk factors and methods of assessment. Arthritis Res Ther. 2012 May 8;14(3):R108. doi: 10.1186/ar3833.
- Background: PubMed 15761730Feldtkeller E, Vosse D, Geusens P, van der Linden S. Prevalence and annual incidence of vertebral fractures in patients with ankylosing spondylitis. Rheumatol Int. 2006 Jan;26(3):234-9. doi: 10.1007/s00296-004-0556-8. Epub 2005 Mar 11.
- Background: PubMed 25710858Dursun N, Sarkaya S, Ozdolap S, Dursun E, Zateri C, Altan L, Birtane M, Akgun K, Revzani A, Aktas I, Tastekin N, Celiker R. Risk of falls in patients with ankylosing spondylitis. J Clin Rheumatol. 2015 Mar;21(2):76-80. doi: 10.1097/RHU.0000000000000216.
- Individual participant dataSharing planned: No
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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.
Laura Passalent principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health technology-based intervention strategy in people with Axial Spondyloarthritis, run by University Health Network, Toronto at 1 site in Canada.
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 4 inclusion and 3 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 3 Nov 2022. 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 Canada. 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 Jennifer Dutra ((416) 603-5800 ext. 5226, jennifer.dutra@uhnresearch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in levels of physical activity as measured by the International Physical Activity Questionnaire-Short Form questionnaire (IPAQ-SF) (time frame: Assessed electronically by an e-survey platform at baseline, 3, 6, 9 and 12 weeks in the intervention and control groups.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05504616, which also lists 52 linked publications.
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 3 Nov 2022.