Virtual Intervention for Vertebral frActures (VIVA): protocol for a feasibility study of a multicentre randomized controlled trial
Abstract Background Vertebral fractures due to osteoporosis cause significant pain and disability. There is guidance available on the management of osteoporotic vertebral fractures, informed by systematic reviews and a consensus process. However, few studies examine whether implementing pragmatic an...
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2025-07-01
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| Series: | Pilot and Feasibility Studies |
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| Online Access: | https://doi.org/10.1186/s40814-025-01665-x |
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| author | Ada Sevinc Alexandra Papaioannou Suzanne N. Morin Jennifer A. Watt Raheem B. Kherani Sheila Brien Larry Funnell Lehana Thabane Lauren A. Beaupre Jenna C. Gibbs Heather Keller Caitlin McArthur Matteo Ponzano Sonia Singh Sharon Straus Jenny Thain Zachary J. Weston Timothy H. Wideman Christopher D. Witiw Lora Giangregorio |
| author_facet | Ada Sevinc Alexandra Papaioannou Suzanne N. Morin Jennifer A. Watt Raheem B. Kherani Sheila Brien Larry Funnell Lehana Thabane Lauren A. Beaupre Jenna C. Gibbs Heather Keller Caitlin McArthur Matteo Ponzano Sonia Singh Sharon Straus Jenny Thain Zachary J. Weston Timothy H. Wideman Christopher D. Witiw Lora Giangregorio |
| author_sort | Ada Sevinc |
| collection | DOAJ |
| description | Abstract Background Vertebral fractures due to osteoporosis cause significant pain and disability. There is guidance available on the management of osteoporotic vertebral fractures, informed by systematic reviews and a consensus process. However, few studies examine whether implementing pragmatic and patient-oriented rehabilitation interventions can improve outcomes for individuals with a vertebral fracture. Methods The purpose of the study is to investigate the feasibility of a multicentre randomized controlled trial of an 8-week virtual rehabilitation intervention for people with an osteoporotic vertebral fracture in Ontario, British Columbia, and Quebec. The design is a multicentre randomized controlled trial with two parallel groups randomized in a 1:1 ratio, stratified by centre to immediate or delayed (10 weeks after randomization) receipt of the Virtual Intervention for Vertebral frActures (VIVA). Four centres will each recruit eight individuals (total n = 32) over the age of 50 who have had at least one vertebral fracture in the past 2 years confirmed by a radiology report. VIVA involves once weekly virtual rehabilitation sessions delivered over 8 weeks by an exercise professional, covering four areas: pain management, safe movement, exercise, and nutrition. Exercise professional provides resources and prescribes exercise therapy for participants to implement outside of the scheduled sessions. The primary feasibility outcomes are recruitment, retention, and adherence, and criteria for success are as follows: (a) recruiting eight people per site in 5 months, (b) 80% of participants completing the trial, and (c) 75% adherence to the virtual rehabilitation sessions. The secondary outcomes include costs relative to benefit, effects on health-related outcomes (e.g. 30-s chair stand, Brief Pain Inventory, Quality of Life Questionnaire of the European Foundation for Osteoporosis-41, SCREEN-14), and outcomes related to implementation (e.g. participant and provider experience using semi-structured interviews, fidelity, number of screened and enrolled participants by referral source, fracture verification process). Descriptive analyses (e.g. mean, count, percentage) will be performed for primary feasibility outcomes and secondary outcomes. Discussion The results will establish the feasibility of a future trial investigating the effectiveness of the VIVA intervention in people with an osteoporotic vertebral fracture. Trial registration The trial was registered in ClinicalTrials.gov on October 21, 2024 (NCT06650410), https://clinicaltrials.gov/study/NCT06650410 . |
| format | Article |
| id | doaj-art-4bd97ed200be4bcc8f26992a98aeb7a7 |
| institution | Kabale University |
| issn | 2055-5784 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj-art-4bd97ed200be4bcc8f26992a98aeb7a72025-08-20T03:37:19ZengBMCPilot and Feasibility Studies2055-57842025-07-0111111310.1186/s40814-025-01665-xVirtual Intervention for Vertebral frActures (VIVA): protocol for a feasibility study of a multicentre randomized controlled trialAda Sevinc0Alexandra Papaioannou1Suzanne N. Morin2Jennifer A. Watt3Raheem B. Kherani4Sheila Brien5Larry Funnell6Lehana Thabane7Lauren A. Beaupre8Jenna C. Gibbs9Heather Keller10Caitlin McArthur11Matteo Ponzano12Sonia Singh13Sharon Straus14Jenny Thain15Zachary J. Weston16Timothy H. Wideman17Christopher D. Witiw18Lora Giangregorio19Department of Kinesiology and Health Sciences, University of WaterlooDivision of Geriatric Medicine & Rheumatology and Department of Health Research Methods, Evidence, and Impact, McMaster UniversityDepartment of Medicine, McGill UniversityDepartment of Medicine, University of TorontoDivision of Rheumatology, Department of Medicine, Arthritis Research Canada, University of British ColumbiaOsteoporosis CanadaOsteoporosis CanadaDepartment of Health Research Methods, Evidence, and Impact, St. Joseph’s Healthcare Hamilton, McMaster UniversityDepartment of Physical Therapy, Faculty of Rehabilitation Medicine, University of AlbertaDepartment of Kinesiology and Physical Education, McGill UniversitySchlegel Research Institute for Aging and Department of Kinesiology and Health Sciences, University of WaterlooSchool of Physiotherapy, Dalhousie UniversitySchool of Health and Exercise Sciences and International Collaboration On Repair Discoveries (ICORD), Blusson Spinal Cord Centre (BSCC), The University of British ColumbiaDepartment of Family Practice, Faculty of Medicine, University of British ColumbiaGeriatric Medicine, Department of Medicine, Knowledge Translation Program, St. Michael’s Hospital, Li Ka Shing Knowledge Institute, University of TorontoDivision of Geriatric Medicine, Western UniversityCanadian Society for Exercise PhysiologySchool of Physical and Occupational Therapy, McGill UniversityDivision of Neurosurgery, Department of Surgery, University of TorontoSchlegel Research Institute for Aging and Department of Kinesiology and Health Sciences, University of WaterlooAbstract Background Vertebral fractures due to osteoporosis cause significant pain and disability. There is guidance available on the management of osteoporotic vertebral fractures, informed by systematic reviews and a consensus process. However, few studies examine whether implementing pragmatic and patient-oriented rehabilitation interventions can improve outcomes for individuals with a vertebral fracture. Methods The purpose of the study is to investigate the feasibility of a multicentre randomized controlled trial of an 8-week virtual rehabilitation intervention for people with an osteoporotic vertebral fracture in Ontario, British Columbia, and Quebec. The design is a multicentre randomized controlled trial with two parallel groups randomized in a 1:1 ratio, stratified by centre to immediate or delayed (10 weeks after randomization) receipt of the Virtual Intervention for Vertebral frActures (VIVA). Four centres will each recruit eight individuals (total n = 32) over the age of 50 who have had at least one vertebral fracture in the past 2 years confirmed by a radiology report. VIVA involves once weekly virtual rehabilitation sessions delivered over 8 weeks by an exercise professional, covering four areas: pain management, safe movement, exercise, and nutrition. Exercise professional provides resources and prescribes exercise therapy for participants to implement outside of the scheduled sessions. The primary feasibility outcomes are recruitment, retention, and adherence, and criteria for success are as follows: (a) recruiting eight people per site in 5 months, (b) 80% of participants completing the trial, and (c) 75% adherence to the virtual rehabilitation sessions. The secondary outcomes include costs relative to benefit, effects on health-related outcomes (e.g. 30-s chair stand, Brief Pain Inventory, Quality of Life Questionnaire of the European Foundation for Osteoporosis-41, SCREEN-14), and outcomes related to implementation (e.g. participant and provider experience using semi-structured interviews, fidelity, number of screened and enrolled participants by referral source, fracture verification process). Descriptive analyses (e.g. mean, count, percentage) will be performed for primary feasibility outcomes and secondary outcomes. Discussion The results will establish the feasibility of a future trial investigating the effectiveness of the VIVA intervention in people with an osteoporotic vertebral fracture. Trial registration The trial was registered in ClinicalTrials.gov on October 21, 2024 (NCT06650410), https://clinicaltrials.gov/study/NCT06650410 .https://doi.org/10.1186/s40814-025-01665-xOsteoporosisVertebral fractureRehabilitationExerciseFeasibility |
| spellingShingle | Ada Sevinc Alexandra Papaioannou Suzanne N. Morin Jennifer A. Watt Raheem B. Kherani Sheila Brien Larry Funnell Lehana Thabane Lauren A. Beaupre Jenna C. Gibbs Heather Keller Caitlin McArthur Matteo Ponzano Sonia Singh Sharon Straus Jenny Thain Zachary J. Weston Timothy H. Wideman Christopher D. Witiw Lora Giangregorio Virtual Intervention for Vertebral frActures (VIVA): protocol for a feasibility study of a multicentre randomized controlled trial Pilot and Feasibility Studies Osteoporosis Vertebral fracture Rehabilitation Exercise Feasibility |
| title | Virtual Intervention for Vertebral frActures (VIVA): protocol for a feasibility study of a multicentre randomized controlled trial |
| title_full | Virtual Intervention for Vertebral frActures (VIVA): protocol for a feasibility study of a multicentre randomized controlled trial |
| title_fullStr | Virtual Intervention for Vertebral frActures (VIVA): protocol for a feasibility study of a multicentre randomized controlled trial |
| title_full_unstemmed | Virtual Intervention for Vertebral frActures (VIVA): protocol for a feasibility study of a multicentre randomized controlled trial |
| title_short | Virtual Intervention for Vertebral frActures (VIVA): protocol for a feasibility study of a multicentre randomized controlled trial |
| title_sort | virtual intervention for vertebral fractures viva protocol for a feasibility study of a multicentre randomized controlled trial |
| topic | Osteoporosis Vertebral fracture Rehabilitation Exercise Feasibility |
| url | https://doi.org/10.1186/s40814-025-01665-x |
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