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Completed

NCT Number: NCT06650410

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

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.

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Key information

Conditions

Osteoporosis Back Injuries Behavior Bone Diseases Bone Diseases, Metabolic Fractures, Bone Fractures, Spinal Metabolic Diseases Motor Activity Musculoskeletal Diseases Nutritional and Metabolic Diseases Spinal Fractures Spinal Injuries Wounds and Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arthritis Research Canada, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Adherence

    Time frame: Through the 8-week intervention period

    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%.

  2. Recruitment

    Time frame: Through the 5-month recruitment period

    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.

  3. Retention

    Time frame: Through study completion (18 weeks)

    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.

Secondary outcomes

  1. Resource use

    Time frame: Baseline, Week 9, and Week 18

    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.

  2. Implementation

    Time frame: At Week 18

    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.

  3. Pain level

    Time frame: Baseline, Week 9, and Week 18

    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.

  4. Falls self-efficacy

    Time frame: Baseline, Week 9, and Week 18

    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.

  5. Mood

    Time frame: Baseline, Week 9, and Week 18

    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.

  6. Physical activity

    Time frame: Baseline, Week 9, and Week 18

    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.

  7. Nutrition risk

    Time frame: Baseline, Week 9, and Week 18

    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.

  8. Balance

    Time frame: Baseline, Week 9, and Week 18

    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.

  9. Maintenance (exercise adherence at Week 18)

    Time frame: Baseline, Week 9, and 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.

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

    Time frame: Baseline, Week 9, and Week 18

    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.

  11. Falls

    Time frame: Baseline, Week 4, Week 8, and Week 16

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

  12. Fear of movement

    Time frame: Baseline, Week 9, and Week 18

    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.

  13. Reach

    Time frame: At Baseline

    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.

  14. Adoption

    Time frame: Over the 5-month recruitment period

    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).

  15. Physical function

    Time frame: Baseline, Week 9, and Week 18

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

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

  • Arthritis Research Centre of Canada
  • Hamilton Health Sciences Corporation
  • McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Unity Health

Registry information

Acronym: VIVA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 21, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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