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

University of Waterloo

Status: Active, not recruiting

Conditions: Osteoporosis; Fractures, Spinal

Treatments: Other: Virtual Intervention for Vertebral Fractures (VIVA)

Study type: Interventional

Funder types: Other

Identifiers

NCT06650410

4816

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Immediate receipt group

Experimental group

Description:

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.

Treatment:

Other: Virtual Intervention for Vertebral Fractures (VIVA)

Wait-list control and delayed receipt group

Other group

Description:

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.

Treatment:

Other: Virtual Intervention for Vertebral Fractures (VIVA)