Study Summary
This trial will test how using tech like smartphone apps to educate people with axial spondyloarthritis on physical activity can improve their quality of life.
- Ankylosing Spondylitis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
5 Primary · 7 Secondary · Reporting Duration: Assessed electronically by an e-survey platform at baseline, 3, 6, 9 and 12 weeks in the intervention and control groups.
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Control Group
1 of 2
Intervention Group
1 of 2
Active Control
Experimental Treatment
106 Total Participants · 2 Treatment Groups
Primary Treatment: Intervention Group · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
Oregon | 100.0% |
What portion of applicants met pre-screening criteria?
Did not meet criteria | 100.0% |
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- 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.
- Rausch 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.
- 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.
- 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. doi: 10.1136/ard.62.1.20.
- 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. doi: 10.1002/nur.4770100603.
- 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. doi: 10.1249/01.mss.0000185657.86065.98.
- van 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.
- Rudwaleit M, van der Heijde D, Landewe 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, Sorensen IJ, Ozgocmen S, Roussou E, Valle-Onate 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.
- 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.
- Hillsdon M, Foster C, Thorogood M. Interventions for promoting physical activity. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD003180. doi: 10.1002/14651858.CD003180.pub2.
- 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. doi: 10.1016/s0895-4356(03)00220-8.
- 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. doi: 10.1152/japplphysiol.00789.2006. Epub 2006 Oct 19.
- Dagfinrud 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.
- Klingberg 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.
- 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. doi: 10.1007/s00296-004-0556-8. Epub 2005 Mar 11.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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(9):CD010395. doi: 10.1002/14651858.CD010395.pub2.
- 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. doi: 10.1007/s00296-016-3565-5. Epub 2016 Sep 24.
- 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. No abstract available.
- 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.
- Laura Passalent 2022. "Health Technology to Improve Exercise in axSpA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05504616.
Frequently Asked Questions
What aims are being pursued with this experimental research?
"This clinical trial will measure its progress over a twelve-week period, with the primary goal being to evaluate changes in physical activity among participants through the International Physical Activity Questionnaire-Short Form questionnaire (IPAQ-SF). Additionally, secondary outcomes include alterations in disease severity using the Bath Ankylosing Spondylitis Disease Activity Index (BASDI) questionnaire and assessing patient acceptance of technology based interventions by way of Mobile Application Rating Scale." - Anonymous Online Contributor
How many participants is the clinical trial recruiting?
"Affirmative. Data hosted on clinicaltrials.gov certify that this medical experiment, which was originally posted on July 21st 2022, is presently enrolling participants. Approximately 106 individuals must be recruiter from a single facility." - Anonymous Online Contributor
Is participation in this clinical trial still an option for potential volunteers?
"Affirmative. The data hosted on clinicaltrials.gov demonstrates that enrollment is still ongoing for this medicinal research, which was initially posted on July 21st 2022 and recently changed on November 2nd 2022. 106 individuals need to be brought into the study from 1 centre." - Anonymous Online Contributor