Clinical trial NCT06650410: Virtual Intervention for Vertebral frActure: a Pilot, Feasibility Study for a Multicentre Randomized Controlled Trial
Official title: Virtual Intervention for Vertebral frActure: a Pilot, Feasibility Study for a Multicentre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoporosis
Fractures, Spinal
Keywords: Rehabilitation
Spine fracture
Exercise
Physical functioning
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Unity Health
name: Arthritis Research Centre of Canada
name: Hamilton Health Sciences Corporation
name: McGill University Health Centre/Research Institute of the McGill University Health Centre
First posted: 2024-10-21
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: OTHER

Brief 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. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence
timeFrame: Through the 8-week intervention period
measure: Recruitment
timeFrame: Through the 5-month recruitment period
measure: Retention
timeFrame: Through study completion (18 weeks)
Secondary outcomes:
measure: Resource use
timeFrame: Baseline, Week 9, and Week 18
measure: Implementation
timeFrame: At Week 18
measure: Pain level
timeFrame: Baseline, Week 9, and Week 18
measure: Falls self-efficacy
timeFrame: Baseline, Week 9, and Week 18
measure: Mood
timeFrame: Baseline, Week 9, and Week 18
measure: Physical activity
timeFrame: Baseline, Week 9, and Week 18
measure: Nutrition risk
timeFrame: Baseline, Week 9, and Week 18
measure: Balance
timeFrame: Baseline, Week 9, and Week 18
measure: Maintenance (exercise adherence at Week 18)
timeFrame: Baseline, Week 9, and Week 18
measure: Quality of Life Questionnaire of the European Foundation for Osteoporosis
timeFrame: Baseline, Week 9, and Week 18
measure: Falls
timeFrame: Baseline, Week 4, Week 8, and Week 16
measure: Fear of movement
timeFrame: Baseline, Week 9, and Week 18
measure: Reach
timeFrame: At Baseline
measure: Adoption
timeFrame: Over the 5-month recruitment period
measure: Physical function
timeFrame: Baseline, Week 9, and Week 18
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Arthritis Research Canada
state: British Columbia
city: Hamilton
country: Canada
facility: Geras Centre for Aging Research
state: Ontario
city: Toronto
country: Canada
facility: Unity Health Toronto
state: Ontario
city: Montréal
country: Canada
facility: Research Institute of the McGill University Health Centre
state: Quebec
Study officials:
affiliation: University of Waterloo
name: Lora Giangregorio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.