Virtual Intervention for Vertebral frActures (VIVA): protocol for a feasibility study of a multicentre randomized controlled trial
Bibliographic record
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 .
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.009 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".