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

NCT06650410 | Completed

• 1 other identifier: 4816
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 4

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.

Conditions

Osteoporosis; Fractures, Spinal

Keywords

Rehabilitation; Spine fracture; Exercise; Physical functioning

Outcome Measures

Primary Outcomes (3)

• Adherence

  The adherence will be reported as the proportion of scheduled sessions participants attend. A future trial will be feasible if the adherence to the intervention sessions is 75%.

  Through the 8-week intervention period

• Recruitment

  The recruitment will be reported as the number of participants recruited by each site. Feasibility criteria for recruitment will be satisfied if we recruit 8 people per site in five months.

  Through the 5-month recruitment period

• Retention

  The retention will be reported as the proportion of participants who complete the final assessment out of the total number of participants. The feasibility criteria for retention will be satisfied if 80% of participants complete the trial.

  Through study completion (18 weeks)

Secondary Outcomes (15)

• Resource use

  Baseline, Week 9, and Week 18

• Implementation

  At Week 18

• Pain level

  Baseline, Week 9, and Week 18

• Falls self-efficacy

  Baseline, Week 9, and Week 18

• Mood

  Baseline, Week 9, and Week 18

Study Arms (2)

Immediate receipt group

EXPERIMENTAL

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: Virtual Intervention for Vertebral Fractures (VIVA)

Wait-list control and delayed receipt group

OTHER

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.

Other: Virtual Intervention for Vertebral Fractures (VIVA)

Interventions

Virtual Intervention for Vertebral Fractures (VIVA) OTHER

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.

Immediate receipt group; Wait-list control and delayed receipt group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Waterloo: lead
• Unity Health: collaborator
• Arthritis Research Centre of Canada: collaborator
• Hamilton Health Sciences Corporation: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (4)

Arthritis Research Canada

Vancouver, British Columbia, V5Y 3P2, Canada

Location

Geras Centre for Aging Research

Hamilton, Ontario, L8M 1W9, Canada

Location

Unity Health Toronto

Toronto, Ontario, M5B 1W8, Canada

Location

Research Institute of the McGill University Health Centre

Montreal, Quebec, H3H 2R9, Canada

Location

Related Publications (2)

• 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.

  PMID: 37555708 BACKGROUND

• Sevinc A, Papaioannou A, Morin SN, Watt JA, Kherani RB, Brien S, Funnell L, Thabane L, Beaupre LA, Gibbs JC, Keller H, McArthur C, Ponzano M, Singh S, Straus S, Thain J, Weston ZJ, Wideman TH, Witiw CD, Giangregorio L. Virtual Intervention for Vertebral frActures (VIVA): protocol for a feasibility study of a multicentre randomized controlled trial. Pilot Feasibility Stud. 2025 Jul 5;11(1):94. doi: 10.1186/s40814-025-01665-x.

  PMID: 40618179 DERIVED

MeSH Terms

Conditions

Osteoporosis; Spinal Fractures; Motor Activity

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone; Behavior

Study Officials

• Lora Giangregorio, PhD

  University of Waterloo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and outcome assessors will be blind to group allocation of participants. Participants will not be blind to group allocation because they will know what group they are assigned to. The randomization sequence will be created and maintained using REDCap and will be conducted by exercise professionals delivering the intervention who are not blind to group allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 21, 2024
• Study Start: January 28, 2025
• Primary Completion: March 26, 2026
• Study Completion: March 30, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

CA (4)