An interventional study of VIVA in Osteoporosis and Vertebral Fracture, sponsored by University of Waterloo. Recruiting at 1 site in Canada. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by University of Waterloo · Not applicable, Interventional, and Health services research
This study will determine feasibility of a chiropractor delivered virtual intervention for individuals following osteoporotic vertebral fracture.
This pilot trial will have two parallel groups with a 1:1 ratio. Participants will be randomized to: 1) immediate receipt; or 2) waitlist usual care control and delayed receipt of VIVA 10 weeks post-randomization.
VIVA is an intervention for people with vertebral fractures that covers four areas: pain management, safe movement, exercise, and nutrition. It includes print and video resources, and a framework for goal setting, selecting exercises, and teaching body mechanics.
A chiropractor (DC) completes a virtual assessment and then leads twelve 1:1 virtual sessions (via Zoom) over eight weeks. Sessions start with brief education on a topic (e.g., safe movement, pain management, exercise, nutrition), followed by training and modeling of exercise and safe movement strategies, then goal setting, and action planning.
This trial will be considered feasible if a) we recruit 14 people in eight months; b) 80% of participants complete the trial; and c) exercise adherence is 75%.
Spine fractures are the most common fracture due to osteoporosis. They can happen because of falls or activities of daily life like bending and lifting. Fractures of the spine can result in pain, which can last for a long time. Spine fractures can affect breathing, appetite, digestion, and mobility, and can restrict or modify an individuals' work or daily activities.
There are no standard rehabilitation programs after spine fracture, and patients often must pay out of pocket for rehabilitation. Rehabilitation can be hard to access (especially in rural or remote locations) and it can be difficult to find providers with training and expertise to treat spine fractures.
Our team includes Osteoporosis Canada, patients, health care professionals, and researchers from multiple provinces. We reviewed research, consulted patients and healthcare providers to understand their experiences with spine fracture rehabilitation to develop a Toolkit for a virtual rehabilitation program for people with spine fracture, called VIVA.
VIVA is an intervention for people with vertebral fractures that covers four areas: pain management, safe movement, exercise, and nutrition. It includes print and video resources, and a framework for goal setting, selecting exercises, and teaching body mechanics. We used the Behavior Change Wheel method to select four implementation strategies: education on pain management, safe movement, exercise, and nutrition; modeling of and training on exercises, safe movement, and pain management strategies; and enablement, such as goal setting, action planning, and self-monitoring.
Participants receive a technology consultation 1-2 weeks prior to baseline assessment, and receive intervention in week one (immediately post-randomization) or in week ten (waitlist control). A provider completes a virtual assessment, and then leads 1:1 once-weekly virtual sessions (via Zoom) over eight weeks. Sessions start with brief education on a topic (e.g., safe movement, pain management, exercise, nutrition), followed by training and modeling of exercise and safe movement strategies, then goal setting, and action planning.
The provider prescribes resources (e.g., summaries, pictures, videos) using the Wibbi app (https://wibbi.com/) or that can be emailed or mailed. Exercises are tailored to the participant's abilities, and target balance, muscle strength, and endurance of back extensor muscles and scapular stabilizers. The first session will serve as an intake session.
Depending on the patient needs the provider either will provide training on exercises, movement tips, or pain management tips. Finally, the provider will show how to monitor performance and adherence throughout the intervention, discuss and decide on the area of focus for the next session (i.e., pain management, safe movement, exercise, nutrition), and schedule the next session.
The remaining 11 sessions from Week 2 to Week 8 will start with education on the chosen topic. The provider will review progress on exercises, movement strategies, or pain management tips from the previous sessions and demonstrate new exercises or strategies. The provider will deliver the exercises prescribed and any educational resources through the Wibbi app and decide on an area of focus for the next session based on discussion with the participant.
VIVA was designed and user tested in the context of physiotherapist delivery, but chiropractors may be well-situated to deliver VIVA. Chiropractors and physiotherapists manage similar patient bases with overlapping scopes of practice. We propose a pilot study of the feasibility of the implementation of the VIVA Toolkit with a chiropractor as the provider (i.e., Can we recruit people? Do they like the program? Do they attend?). Through this study we will also collect information about pain, quality of life and physical functioning before and after the intervention. We will then use the findings of this study to determine if it is feasible to include chiropractor providers in a larger clinical trial.
1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.
This study's planned enrollment of 15 is below the median of 88 across 1,084 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →University of Waterloo is the lead sponsor of 90 studies on the registry; 7 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 9 (75%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a technology consultation 1-2 weeks prior to baseline assessment, and receive intervention in week one (immediately post-randomization). Following a virtual assessment, participants will receive twelve 1:1 virtual sessions (via Zoom) over eight weeks.
Behavioral: VIVA
Participants receive a technology consultation 1-2 weeks prior to baseline assessment, and receive intervention in week ten (waitlist control).
VIVA is an intervention for people with vertebral fractures that covers four areas: pain management, safe movement, exercise, and nutrition. It includes print and video resources, and a framework for goal setting, selecting exercises, and teaching body mechanics.
Feasibility of Chiropractic Delivery
This trial will be considered feasible if a) we recruit 14 people in eight months; b) 80% of participants complete the trial; and c) exercise adherence is 75%.
Time frame: We will consider ≥80% retention at 20 weeks acceptable. Adherence will be defined as ≥2 sessions per week of exercise at 20 weeks
Participant experience
We will lead exit interviews using an interview guide with open-ended questions guided by user-centred design principles.
Time frame: At completion of 10 weeks.
Pain and Quality of Life
Using the QUALEFFO-41 to measure health-related quality of life, the QUALEFFO-41 also includes questions on pain.
Time frame: Will be measured at weeks 10/20 (effectiveness) and 20 weeks (sustainability, immediate group only
Health-Related Quality of life
We will use the EuroQOL instrument (EQ5D5L) to measure health-related quality of life
Time frame: Will be measured at weeks 10/20 (effectiveness) and 20 weeks (sustainability, immediate group only
Physical Performance - Balance
We will assess static balance via three point balance scale from the Short Physical Performance Battery. Scoring: A. Side-by-side-stand Held for 10 sec ❒ 1 point Not held for 10 sec ❒ 0 points Not attempted ❒ 0 points Number of seconds held if less than 10 sec: \_\_\_\_\_\_\_ sec \*If 0 points, end Balance Tests B. Semi-Tandem Stand Held for 10 sec ❒ 1 point Not held for 10 sec ❒ 0 points Not attempted ❒ 0 points Number of seconds held if less than 10 sec: \_\_\_\_\_\_\_ sec \*If 0 points, end Balance Tests C. Tandem Stand Held for 10 sec ❒ 2 points Held for 3 to 9.99 sec ❒ 1 point Held for \< than 3 sec ❒ 0 points Not attempted ❒ 0 points (circle reason above)
Time frame: Physical performance will be measured at weeks 10/20 (effectiveness) and 20 (sustainability, immediate group only).
Physical Performance - Sit to Stand Performance
We will assess sit-to-stand performance (30 Second Chair Stand Test). Test Instructions With your shoes on, complete as many repetitions as you can safely and at your own pace. Single Chair Stand (Practice) 1. Sit in the middle of the chair. 2. Keep your feet flat on the floor, hip width apart. 3. Keep your back straight and hold your arms across the chest. 4. Rise to a full standing position, then sit back down again. 5. If you are able to complete one repetition safely, proceed with the full test on the next page. If not, this is the end of the test. Scoring: 30s Chair Stand Test AGE Men Women 60-64 \< 14 \< 12 65-69 \< 12 \< 11 70-74 \< 12 \< 10 75-79 \< 11 \< 10 80-84 \< 10 \< 9 85-89 \< 8 \< 8 90-94 \< 7. \< 4
Time frame: Physical performance will be measured at weeks 10/20 (effectiveness) and 20 (sustainability, immediate group only)
Adherence to diet recommendations
Protein, calcium, vitamin D and energy intake will be measured with ASA24 and compared to Health Canada recommended dietary allowances.
Time frame: Measured at 20 weeks, immediate group only
Adverse events
We will ask participants to report adverse events, defined using Health Canada definitions and established protocols. We will report all serious and non-serious adverse events (including falls, fractures) and identify them as: a) Expected/Unexpected and b) Related/unrelated to the intervention program. Participants instructed to inform chiropractor if they have an adverse event. "If you have an illness, injury, or need to get medical help, whether it is due to study participation or not, please contact us." During the week 10 and week 20 assessments, assessors to inquire about whether the participant had any illnesses or injuries.
Time frame: On-going, disclosed during intervention sessions, or at assessment milestones (week 10 and 20).
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