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ACTIVE NOT RECRUITING
NCT06650410
NA

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

Sponsor: University of Waterloo

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-01-28

Completion Date

2026-04

Last Updated

2025-11-25

Healthy Volunteers

No

Interventions

OTHER

Virtual Intervention for Vertebral Fractures (VIVA)

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.

Locations (4)

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