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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Geras Centre for Aging Research
ACTIVE_NOT_RECRUITING
Hamilton
Research Institute of the McGill University Health Centre
RECRUITING
Montreal
Unity Health Toronto
ACTIVE_NOT_RECRUITING
Toronto
Arthritis Research Canada
ACTIVE_NOT_RECRUITING
Vancouver
Contact Information
Primary
Lora Giangregorio, PhD
lora.giangregorio@uwaterloo.ca
519-888-4567
Time Frame
Start Date: 2025-01-28
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 32
Treatments
Experimental: Immediate receipt group
Participants 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.
Other: Wait-list control and delayed receipt group
Participants 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.
Related Therapeutic Areas
Sponsors
Collaborators: Arthritis Research Centre of Canada, McGill University Health Centre/Research Institute of the McGill University Health Centre, Hamilton Health Sciences Corporation, Unity Health
Leads: University of Waterloo

This content was sourced from clinicaltrials.gov