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OsteoporosisVIVANCT06650410

Virtual Intervention for Vertebral frActure: a Pilot, Feasibility Study for a Multicentre Randomized Controlled Trial

A study testing Virtual Intervention for Vertebral Fractures (VIVA) in people with Osteoporosis and Fractures, Spinal, run by University of Waterloo at 4 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Spine fractures are the most common fracture due to osteoporosis. They happen during falls or activities of daily life, like bending to tie shoes. Fractures of the spine can result in pain, which can sometimes last for a long time. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Osteoporosis, Fractures, Spinal
What is being tested?
Virtual Intervention for Vertebral Fractures (VIVA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
4 sitesCanada
Study dates
28 Jan 2025to 30 Mar 2026
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • have had at least one vertebral fracture in the past two years confirmed by a radiology report
  • willing to participate in once weekly virtual rehabilitation sessions for 8 weeks
  • have access to internet and a smart device with a camera and microphone.

Who cannot join

  • have cauda equina syndrome or spinal cord injury or spinal cord injury
  • had a traumatic fracture (i.e., car accident); an active infection; active inflammatory arthritis with a flare up within the past two years
  • an inability to follow two-step commands or understand instructions and are without a caregiver to support participation
  • been participating in a similar rehabilitation program for vertebral fractures delivered by a physical therapist, exercise physiologist or kinesiologist and includes exercise
  • any surgeries planned or health problems that might cause their health to change significantly in the next 3 months

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • Geras Centre for Aging Research

    Hamilton, Ontario, L8M 1W9

  • Research Institute of the McGill University Health Centre

    Montreal, Quebec, H3H 2R9

  • Unity Health Toronto

    Toronto, Ontario, M5B 1W8

  • Arthritis Research Canada

    Vancouver, British Columbia, V5Y 3P2

Other trials in Canada

About this study

Spine fractures are the most common fracture due to osteoporosis. They happen during falls or activities of daily life, like bending to tie shoes. Fractures of the spine can result in pain, which can sometimes last for a long time. Spine fractures can affect breathing, appetite, digestion, and mobility, and can restrict or modify people's work or daily activities. There are no standard rehabilitation programs after spine fracture, and patients often have to pay for rehabilitation. Rehabilitation can be hard to access, especially in rural or remote locations. It can be hard to find health care or rehabilitation providers who specialize in treating spine fractures. After reviewing research and consulting patients and health care providers to understand their experiences with spine fracture rehabilitation, the research team developed a toolkit for a virtual rehabilitation program for people with spine fractures, called VIVA.

The research team wants to submit a grant for a clinical trial to implement VIVA in five provinces and determine if VIVA reduces pain and improves physical functioning and quality of life, and if the benefits outweigh the costs. Before this, the team proposes to do a pilot study to test how feasible it is to do a study of VIVA in three provinces.

Read the detailed description

A multicenter trial will be conducted to investigate the feasibility of a future trial of VIVA in adults with spine fractures in Ontario, British Columbia, and Quebec. As secondary outcomes, the research team will explore the effect of the intervention on physical function and balance, pain, fear of movement, falls, falls self-efficacy, quality of life, mood, nutrition risk, and physical activity. Adults over the age of 50 who have had at least one spine fracture in the past two years due to osteoporosis will be recruited. Participants will be randomized either to the immediate receipt of VIVA intervention; or delayed receipt of VIVA 10 weeks post-randomization. The VIVA intervention involves once weekly 1:1 rehabilitation sessions delivered by an exercise professional for eight weeks. The study will take place at the GERAS Centre (Ontario), Unity Health (Ontario), University of British Columbia (British Columbia), and McGill University Health Centre (Quebec). University of Waterloo will be the coordinating centre. The findings of this study will be used to decide if a larger clinical trial is feasible.

Being tested
Virtual Intervention for Vertebral Fractures (VIVA)
Keywords
Rehabilitation, Spine fracture, Exercise, Physical functioning
Medical subject headings
Osteoporosis, Spinal Fractures, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Intervention for Vertebral Fractures (VIVA)Other

    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. An exercise professional leads 1:1 once-weekly sessions (in person or virtual) over eight weeks. Sessions start with brief education on a topic, followed by training and modeling of exercise and safe movement strategies, then goal setting, and action planning. The exercise professional prescribes resources using an app 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.

Study groups in NCT06650410
Study groupRoleWhat they receive
Immediate receipt groupExperimentalParticipants in this group will receive the VIVA intervention in the first 8 weeks of the study. After the 8-week period, participants will be asked to practice behaviour change techniques for the next 10 weeks.
Receives: Other: Virtual Intervention for Vertebral Fractures (VIVA)
Wait-list control and delayed receipt groupOtherParticipants in this group will continue with their usual care for the first 10 weeks of the study. At week 10, they will receive the same VIVA intervention.
Receives: Other: Virtual Intervention for Vertebral Fractures (VIVA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence

    The adherence will be reported as the proportion of scheduled sessions participants attend.

    A future trial will be feasible if the adherence to the intervention sessions is 75%.

    Measured: Through the 8-week intervention period

  2. Recruitment

    The recruitment will be reported as the number of participants recruited by each site.

    Feasibility criteria for recruitment will be satisfied if we recruit 8 people per site in five months.

    Measured: Through the 5-month recruitment period

  3. Retention

    The retention will be reported as the proportion of participants who complete the final assessment out of the total number of participants.

    The feasibility criteria for retention will be satisfied if 80% of participants complete the trial.

    Measured: Through study completion (18 weeks)

Secondary outcomes (15)

  1. Resource use

    The economic evaluation will be conducted from health system and societal perspectives using questionnaires. Participants will complete EQ5D-3L as a measure of morbidity and multiply it by mortality to achieve a quality-adjusted life year (QALY) estimate per intervention. Multiplying resources collected by jurisdictional unit costs in Canadian dollars will determine the total cost. The ratio of incremental costs between arms will be calculated, determined by trial resources, and outcome (QALY) to achieve a cost per life year gained outcome.

    Measured: Baseline, Week 9, and Week 18

  2. Implementation

    The participant and provider experiences will be captured via semi-structured interviews. Participants will report adherence to the prescribed exercise using Wibbi app or a log (participant preference). With consent, two sessions per site, selected at random, will be recorded. Research assistant will complete a checklist to assess intervention fidelity.

    Measured: At Week 18

  3. Pain level

    Participants will be administered the Brief Pain Inventory Short Form to assess pain. The wording of the questions will be modified to adapt them to the context specific to our population. The mean score of the four items will be calculated to determine pain severity, ranging from 0 to 10. The pain interference will be calculated as the mean score of 10 items that measure the impact of pain on various activities, ranging from 0 to 10.

    Measured: Baseline, Week 9, and Week 18

  4. Falls self-efficacy

    Participants will complete Short Falls Self-Efficacy questionnaire to assess fear of falling. The cut-points for degrees of concern about falling are established wherein scores 7 and 8 represent a low concern, 9 to 13 indicate a moderate concern, and 28 to 64 represent a high concern for falls.

    Measured: Baseline, Week 9, and Week 18

  5. Mood

    Participants will complete Patient Health Questionnaire-8 to measure depression. The total score is calculated by adding up the scores of each item, and ranges from 0 to 24. The cut points for mild, moderate, moderately severe, and severe depression are 5, 10, 15, and 20, respectively.

    Measured: Baseline, Week 9, and Week 18

  6. Physical activity

    Participants will complete Physical Activity for Elderly questionnaire to measure physical activity levels. The total score is calculated using an algorithm that multiplies activity weights by activity frequencies. Higher scores correspond to greater physical activity levels.

    Measured: Baseline, Week 9, and Week 18

  7. Nutrition risk

    Participants will complete SCREEN-14 tool to measure nutrition risk. The score ranges from 0 to 64. Individuals who receive a score less than 50 are considered nutritionally at risk. A score of 2 or less from an individual response may help understand the items that put individuals at nutrition risk.

    Measured: Baseline, Week 9, and Week 18

  8. Balance

    Participants will perform a series of balance tests (side-by-side stand, semi-tandem stand, tandem stand) to assess balance. The total balance score ranges from 0 to 4 wherein the higher scores represent greater balance.

    Measured: Baseline, Week 9, and Week 18

  9. Maintenance (exercise adherence at Week 18)

    Maintenance will be reported as the adherence to the exercise sessions at the end of 18-week follow-up for immediate group only.

    Measured: Baseline, Week 9, and Week 18

  10. Quality of Life Questionnaire of the European Foundation for Osteoporosis

    Participants will complete the 41-item Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) to measure quality of life. The total score is calculated by summing each item in the questionnaire and then transforming the score to a scale from 0 to 100. Higher scores indicate a greater quality of life.

    Measured: Baseline, Week 9, and Week 18

  11. Falls

    The number of people who fall and rate of falls will be recorded using monthly fall logs. Participants will self-report their falls.

    Measured: Baseline, Week 4, Week 8, and Week 16

  12. Fear of movement

    Participants will complete Tampa Scale of Kinesiophobia to assess the participants' fear of movement related to the pain. The total score ranges from 17 to 68. The lowest score of 17 represents no or little fear of movement whereas the higher scores indicate a greater fear of movement.

    Measured: Baseline, Week 9, and Week 18

  13. Reach

    Reach will be reported using PROGRESS-Plus (Place; Race/ethnicity/culture/language; Occupation; Out of Work, Gender and sex; Religion, Education, Socioeconomic status, Social capital) factors to describe participants. The number of individuals recruited who are ≤12 weeks versus \>12 weeks post-vertebral fracture, and those who attend outcome assessments in-person or virtually will be presented.

    Measured: At Baseline

  14. Adoption

    Adoption will be reported as the number of screened and enrolled patients by referral source. The fracture verification process will also be assessed (i.e., the length of time to obtain radiology reports and number of people with ambiguous radiology reports).

    Measured: Over the 5-month recruitment period

  15. Physical function

    Participants will perform the 30 Second Chair Stand Test to assess lower extremity muscle power. Scores vary depending on age and sex.

    Measured: Baseline, Week 9, and Week 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2024
  2. Study start28 Jan 2025
  3. Primary completion26 Mar 2026
  4. Study completion30 Mar 2026

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized in a 1:1 ratio to one of two arms. The study includes a wait-list control, indicating all participants will receive the intervention but at different time points. One group will receive the intervention immediately, whereas the other group will receive the intervention 10 weeks after being randomized (wait-list control).
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06650410
Sponsor's protocol ID
4816
Acronym
VIVA
Status last verified
Apr 2026
First submitted
25 Sep 2024
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ponzano M, Tibert N, Brien S, Funnell L, Gibbs JC, Keller H, Laprade J, Morin SN, Papaioannou A, Weston ZJ, Wideman TH, Giangregorio LM. Development, Acceptability, and Usability of a Virtual Intervention for Vertebral Fractures. Phys Ther. 2023 Dec 6;103(12):pzad098. doi: 10.1093/ptj/pzad098.

    PubMed 37555708

  • Sevinc A, Papaioannou A, Morin SN, Watt JA, Kherani RB, Brien S, Funnell L, Thabane L, Beaupre LA, Gibbs JC, Keller H, McArthur C, Ponzano M, Singh S, Straus S, Thain J, Weston ZJ, Wideman TH, Witiw CD, Giangregorio L. Virtual Intervention for Vertebral frActures (VIVA): protocol for a feasibility study of a multicentre randomized controlled trial. Pilot Feasibility Stud. 2025 Jul 5;11(1):94. doi: 10.1186/s40814-025-01665-x.

    PubMed 40618179

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Intervention for Vertebral Fractures (VIVA) in people with Osteoporosis and Fractures, Spinal, run by University of Waterloo at 4 sites 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence (time frame: Through the 8-week intervention period). The study lists 3 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 NCT06650410, which also lists 2 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 24 Apr 2026.

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