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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
34
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.
Arthritis Research Canada
Vancouver, British Columbia, Canada
Geras Centre for Aging Research
Hamilton, Ontario, Canada
Unity Health Toronto
Toronto, Ontario, Canada
Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada
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%.
Time frame: Through the 8-week intervention period
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.
Time frame: Through the 5-month recruitment period
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.
Time frame: Through study completion (18 weeks)
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.
Time frame: Baseline, Week 9, and Week 18
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.
Time frame: At Week 18
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.
Time frame: Baseline, Week 9, and Week 18
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.
Time frame: Baseline, Week 9, and Week 18
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.
Time frame: Baseline, Week 9, and Week 18
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.
Time frame: Baseline, Week 9, and Week 18
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.
Time frame: Baseline, Week 9, and Week 18
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.
Time frame: Baseline, Week 9, and Week 18
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.
Time frame: Baseline, Week 9, and Week 18
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.
Time frame: Baseline, Week 9, and Week 18
Falls
The number of people who fall and rate of falls will be recorded using monthly fall logs. Participants will self-report their falls.
Time frame: Baseline, Week 4, Week 8, and Week 16
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.
Time frame: Baseline, Week 9, and Week 18
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.
Time frame: At Baseline
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).
Time frame: Over the 5-month recruitment period
Physical function
Participants will perform the 30 Second Chair Stand Test to assess lower extremity muscle power. Scores vary depending on age and sex.
Time frame: Baseline, Week 9, and Week 18
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