Health Technology to Improve Exercise in axSpA

Axial Spondyloarthritis Clinical Trial

Official title:

Physical Activity in Axial Spondyloarthritis: Development and Implementation of an Evidence-Based Health Technology Approach to Improve Adherence to Recommended Guidelines

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05504616
• Other study ID #: 19-5919
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2022
• Source: University Health Network, Toronto
• Contact: Jennifer Dutra
• Phone: (416) 603-5800
• Email: jennifer.dutra[@]uhnresearch.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.)

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis

Intervention

Other:
• Health technology-based intervention strategy
Patient-centered, technology-based intervention strategy aimed at increasing physical activity in patients with axSpA

Locations

Country	Name	City	State
Canada	University Health Network - Toronto Western Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Initiative for Outcomes in Rheumatology Care

Country where clinical trial is conducted

Canada, 

References & Publications (52)

1. World Health Organization. Fact Sheet Updated February 2018. Available at: http://www.who.int/mediacentre/factsheets/fs385/en/ Accessed on March 26, 2018

American College of Sports Medicine Exercise pre-participation health screening recommendations. 2015 Available at: http://www.acsm.org/docs/default-source/publications/acsm-101-prescreeninginfographiccolorlegal-2015-12-15-v02.pdf?sfvrsn=2 . Accessed on March 28, 2018

Arends S, Hofman M, Kamsma YP, van der Veer E, Houtman PM, Kallenberg CG, Spoorenberg A, Brouwer E. Daily physical activity in ankylosing spondylitis: validity and reliability of the IPAQ and SQUASH and the relation with clinical assessments. Arthritis Res Ther. 2013 Aug 23;15(4):R99. doi: 10.1186/ar4279. — View Citation

Arturi 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. — View Citation

Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research In Psychology 2008;3(2):77-101

Calin A, Garrett S, Whitelock H, Kennedy LG, O'Hea J, Mallorie P, Jenkinson T. A new approach to defining functional ability in ankylosing spondylitis: the development of the Bath Ankylosing Spondylitis Functional Index. J Rheumatol. 1994 Dec;21(12):2281-5. — View Citation

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

Dagfinrud H, Kvien TK, Hagen KB. Physiotherapy interventions for ankylosing spondylitis. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD002822. doi: 10.1002/14651858.CD002822.pub3. Review. — View Citation

Doward LC, Spoorenberg A, Cook SA, Whalley D, Helliwell PS, Kay LJ, McKenna SP, Tennant A, van der Heijde D, Chamberlain MA. Development of the ASQoL: a quality of life instrument specific to ankylosing spondylitis. Ann Rheum Dis. 2003 Jan;62(1):20-6. — View Citation

Dursun 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. — View Citation

Fabre S, Molto A, Dadoun S, Rein C, Hudry C, Kreis S, Fautrel B, Pertuiset E, Gossec L. Physical activity in patients with axial spondyloarthritis: a cross-sectional study of 203 patients. Rheumatol Int. 2016 Dec;36(12):1711-1718. Epub 2016 Sep 24. — View Citation

Fanning J, Mullen SP, McAuley E. Increasing physical activity with mobile devices: a meta-analysis. J Med Internet Res. 2012 Nov 21;14(6):e161. doi: 10.2196/jmir.2171. — View Citation

Feldtkeller 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. Epub 2005 Mar 11. — View Citation

Foster C, Richards J, Thorogood M, Hillsdon M. Remote and web 2.0 interventions for promoting physical activity. Cochrane Database Syst Rev. 2013 Sep 30;9:CD010395. [Epub ahead of print] — View Citation

Garrett S, Jenkinson T, Kennedy LG, Whitelock H, Gaisford P, Calin A. A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index. J Rheumatol. 1994 Dec;21(12):2286-91. — View Citation

Griffiths AJ, White CM, Thain PK, Bearne LM. The effect of interactive digital interventions on physical activity in people with inflammatory arthritis: a systematic review. Rheumatol Int. 2018 Sep;38(9):1623-1634. doi: 10.1007/s00296-018-4010-8. Epub 2018 Mar 19. — View Citation

Haglund E, Bremander A, Bergman S, Larsson I. Educational needs in patients with spondyloarthritis in Sweden - a mixed-methods study. BMC Musculoskelet Disord. 2017 Aug 2;18(1):335. doi: 10.1186/s12891-017-1689-8. — View Citation

Haroon 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. — View Citation

Hillsdon M, Foster C, Thorogood M. Interventions for promoting physical activity. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD003180. Review. — View Citation

Jahangiry L, Farhangi MA, Shab-Bidar S, Rezaei F, Pashaei T. Web-based physical activity interventions: a systematic review and meta-analysis of randomized controlled trials. Public Health. 2017 Nov;152:36-46. doi: 10.1016/j.puhe.2017.06.005. Epub 2017 Jul 20. Review. — View Citation

Kang R, Passalent L, Morton R, Hawke C, Blair J, Lake A, et al. The European league against rheumatism (EULAR) 2013. Utilization of an informational needs assessment to develop an education program for patients with ankylosing spondylitis and related axial spondyloarthritis

Kim J, Shin W. How to do random allocation (randomization). Clin Orthop Surg. 2014 Mar;6(1):103-9. doi: 10.4055/cios.2014.6.1.103. Epub 2014 Feb 14. — View Citation

Klingberg E, Lorentzon M, Mellström D, Geijer M, Göthlin 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. — View Citation

Lawson D, Passalent L, Kang R, Hawke C, Omar A, Thavaneswaran A, Haroon N, Inman RD. Impact of e-learning on perceived social role participation of patients with axial spondyloarthritis: results from a longitudinal randomized control train [abstract]. Arthritis Rheumatol. 2016;68 (suppl 10)

Lorig K, Stewart A, Ritter P, Gonzalez V, Laurent D, Lynch J. Outcome measures for health education and other health care interventions. Thousand Oaks, CA; Sage Publications, 1996, pp.25,37-38

Marcolino MS, Oliveira JAQ, D'Agostino M, Ribeiro AL, Alkmim MBM, Novillo-Ortiz D. The Impact of mHealth Interventions: Systematic Review of Systematic Reviews. JMIR Mhealth Uhealth. 2018 Jan 17;6(1):e23. doi: 10.2196/mhealth.8873. Review. — View Citation

Mayer JE, Fontelo P. Meta-analysis on the effect of text message reminders for HIV-related compliance. AIDS Care. 2017 Apr;29(4):409-417. doi: 10.1080/09540121.2016.1214674. Epub 2016 Aug 1. Review. — View Citation

Miller MG, Herniman JJ, Ricard MD, Cheatham CC, Michael TJ. The effects of a 6-week plyometric training program on agility. J Sports Sci Med. 2006 Sep 1;5(3):459-65. eCollection 2006. — View Citation

Neuberger GB, Kasal S, Smith KV, Hassanein R, DeViney S. Determinants of exercise and aerobic fitness in outpatients with arthritis. Nurs Res. 1994 Jan-Feb;43(1):11-7. — View Citation

O'Dwyer T, McGowan E, O'Shea F, Wilson F. Physical Activity and Exercise: Perspectives of Adults With Ankylosing Spondylitis. J Phys Act Health. 2016 May;13(5):504-13. doi: 10.1123/jpah.2015-0435. Epub 2015 Oct 28. — View Citation

O'Dwyer T, O'Shea F, Wilson F. Decreased physical activity and cardiorespiratory fitness in adults with ankylosing spondylitis: a cross-sectional controlled study. Rheumatol Int. 2015 Nov;35(11):1863-72. doi: 10.1007/s00296-015-3339-5. Epub 2015 Aug 9. — View Citation

O'Dwyer T, O'Shea F, Wilson F. Physical activity in spondyloarthritis: a systematic review. Rheumatol Int. 2015 Mar;35(3):393-404. doi: 10.1007/s00296-014-3141-9. Epub 2014 Oct 10. Review. — View Citation

O'Dwyer T, Rafferty T, O'Shea F, Gissane C, Wilson F. Physical activity guidelines: is the message getting through to adults with rheumatic conditions? Rheumatology (Oxford). 2014 Oct;53(10):1812-7. doi: 10.1093/rheumatology/keu177. Epub 2014 May 14. — View Citation

Oosterom N, Gant CM, Ruiterkamp N, van Beijnum BF, Hermens H, Bakker SJL, Navis G, Vollenbroek-Hutten MMR, Laverman GD. Physical Activity in Patients With Type 2 Diabetes: The Case for Objective Measurement in Routine Clinical Care. Diabetes Care. 2018 Apr;41(4):e50-e51. doi: 10.2337/dc17-2041. Epub 2018 Feb 6. — View Citation

Orr JA, King RJ. Mobile phone SMS messages can enhance healthy behaviour: a meta-analysis of randomised controlled trials. Health Psychol Rev. 2015;9(4):397-416. doi: 10.1080/17437199.2015.1022847. Epub 2015 May 28. Review. — View Citation

Passalent L, Kang R, Lawson D, Hawke C, Omar A, Thavaneswaran A, Haroon N, Inman RD. Impact of e-learning on knowledge, self-efficacy and exercise behaviours in patients with axial spondyloarthritis: results from a longitudinal randomized control trial [abstract]. Arthritis Rheumatol. 2016;68 (suppl 10)

Passalent 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. — View Citation

Rausch Osthoff AK, Niedermann K, Braun J, Adams J, Brodin N, Dagfinrud H, Duruoz T, Esbensen BA, Günther 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. — View Citation

Rudwaleit M, van der Heijde D, Landewé R, Listing J, Akkoc N, Brandt J, Braun J, Chou CT, Collantes-Estevez E, Dougados M, Huang F, Gu J, Khan MA, Kirazli Y, Maksymowych WP, Mielants H, Sørensen IJ, Ozgocmen S, Roussou E, Valle-Oñate R, Weber U, Wei J, Sieper J. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009 Jun;68(6):777-83. doi: 10.1136/ard.2009.108233. Epub 2009 Mar 17. Erratum in: Ann Rheum Dis. 2019 Jun;78(6):e59. — View Citation

Sechrist KR, Walker SN, Pender NJ. Development and psychometric evaluation of the exercise benefits/barriers scale. Res Nurs Health. 1987 Dec;10(6):357-65. — View Citation

Seynnes OR, de Boer M, Narici MV. Early skeletal muscle hypertrophy and architectural changes in response to high-intensity resistance training. J Appl Physiol (1985). 2007 Jan;102(1):368-73. Epub 2006 Oct 19. — View Citation

Sieper J, Rudwaleit M, Baraliakos X, Brandt J, Braun J, Burgos-Vargas R, Dougados M, Hermann KG, Landewé 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. — View Citation

Stock MS, Mota JA, DeFranco RN, Grue KA, Jacobo AU, Chung E, Moon JR, DeFreitas JM, Beck TW. The time course of short-term hypertrophy in the absence of eccentric muscle damage. Eur J Appl Physiol. 2017 May;117(5):989-1004. doi: 10.1007/s00421-017-3587-z. Epub 2017 Mar 20. — View Citation

Stoyanov SR, Hides L, Kavanagh DJ, Zelenko O, Tjondronegoro D, Mani M. Mobile app rating scale: a new tool for assessing the quality of health mobile apps. JMIR Mhealth Uhealth. 2015 Mar 11;3(1):e27. doi: 10.2196/mhealth.3422. — View Citation

Swinnen 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. — View Citation

Trost SG, McIver KL, Pate RR. Conducting accelerometer-based activity assessments in field-based research. Med Sci Sports Exerc. 2005 Nov;37(11 Suppl):S531-43. Review. — View Citation

Tyrrell JS, Redshaw CH. Physical Activity in Ankylosing Spondylitis: evaluation and analysis of an eHealth tool. J Innov Health Inform. 2016 Jul 4;23(2):169. doi: 10.14236/jhi.v23i2.169. — View Citation

van der Heijde D, Calin A, Dougados M, Khan MA, van der Linden S, Bellamy N. Selection of instruments in the core set for DC-ART, SMARD, physical therapy, and clinical record keeping in ankylosing spondylitis. Progress report of the ASAS Working Group. Assessments in Ankylosing Spondylitis. J Rheumatol. 1999 Apr;26(4):951-4. Review. — View Citation

van der Heijde D, Ramiro S, Landewé R, Baraliakos X, Van den Bosch F, Sepriano A, Regel A, Ciurea A, Dagfinrud H, Dougados M, van Gaalen F, Géher P, van der Horst-Bruinsma I, Inman RD, Jongkees M, Kiltz U, Kvien TK, Machado PM, Marzo-Ortega H, Molto A, Navarro-Compàn 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. Review. — View Citation

Ward 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. — View Citation

Wendel-Vos GC, Schuit AJ, Saris WH, Kromhout D. Reproducibility and relative validity of the short questionnaire to assess health-enhancing physical activity. J Clin Epidemiol. 2003 Dec;56(12):1163-9. — View Citation

World Health Organization. Physical activity. Available at: http://www.who.int/topics/physical_activity/en/ Accessed on March 29, 2018

* Note: There are 52 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessed electronically by an e-survey platform at baseline, 3, 6, 9 and 12 weeks in the intervention and control groups.
Primary	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.	Assessed electronically by an e-survey platform at baseline, 3, 6, 9 and 12 weeks in the intervention and control groups.
Primary	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.	Assessed at baseline and at 12 weeks.
Primary	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.	Assessed at baseline and at 12 weeks.
Primary	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'	Assessed at baseline and at 12 weeks.
Secondary	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.	From baseline, assessed up to 12 weeks.
Secondary	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.	From baseline, assessed up to 12 weeks.
Secondary	Number of accepted invites over the course of 12 weeks	Acceptance of planned exercise, as measured by uptake of health technology-based intervention strategy	From baseline, assessed up to 12 weeks.
Secondary	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	From baseline, assessed up to 12 weeks.
Secondary	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	From baseline, assessed up to 12 weeks.
Secondary	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.	Assessed at 12 weeks.
Secondary	Number of enrolled participants who complete the study	Adherence, as measured by the rate of study completion.	Assessed at 12 weeks.