Recruiting

VIVA

Sponsor:

University of Waterloo

Code:

NCT07288684

Conditions

Osteoporosis

Vertebral Fracture

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

VIVA

Study Details

Brief summary:

This study will determine feasibility of a chiropractor delivered virtual intervention for individuals following osteoporotic vertebral fracture.

This pilot trial will have two parallel groups with a 1:1 ratio. Participants will be randomized to: 1) immediate receipt; or 2) waitlist usual care control and delayed receipt of VIVA 10 weeks post-randomization.

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.

A chiropractor (DC) completes a virtual assessment and then leads twelve 1:1 virtual sessions (via Zoom) over eight weeks. Sessions start with brief education on a topic (e.g., safe movement, pain management, exercise, nutrition), followed by training and modeling of exercise and safe movement strategies, then goal setting, and action planning.

This trial will be considered feasible if a) we recruit 14 people in eight months; b) 80% of participants complete the trial; and c) exercise adherence is 75%.

Conditions

Osteoporosis

Vertebral Fracture

Study ID

NCT07288684

Start date

Oct 20, 2025

Status verified date

Oct, 2025

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Over the age of 50 (men or post-menopausal women)
  • Have had a vertebral fracture in the past two years
  • Willing to participate in twelve (12) virtual rehabilitation sessions for 10 weeks
  • Have access to internet and a smart device with a camera and microphone

Exclusion Criteria:

  • Cauda equina syndrome 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

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Immediate Receipt of VIVA

Participants receive a technology consultation 1-2 weeks prior to baseline assessment, and receive intervention in week one (immediately post-randomization).

Following a virtual assessment, participants will receive twelve 1:1 virtual sessions (via Zoom) over eight weeks.

no intervention: Control

Participants receive a technology consultation 1-2 weeks prior to baseline assessment, and receive intervention in week ten (waitlist control).

Interventions

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.

Primary outcome measure

  • Feasibility of Chiropractic Delivery [ Time Frame: We will consider ≥80% retention at 20 weeks acceptable. Adherence will be defined as ≥2 sessions per week of exercise at 20 weeks ]

Central Contacts and Locations

Central contacts

Allison A Legg

289-380-0859a2legg@uwaterloo.ca

Lora Giangregorio, PhD

lora.giangregorio@uwaterloo.ca

Locations

University of Waterloo

Recruiting

Waterloo, Ontario, Canada, N2L3G1

Contacts

Allison A Legg

2893800859a2legg@uwaterloo.ca

Lora Giangregorio, PhD

lora.giangregorio@uwaterloo.ca

More Information

Sponsor

University of Waterloo

Last update posted

Dec 17, 2025

Last verified

Oct, 2025

Keywords

  • Rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-03. This information was provided to ClinicalTrials.gov by University of Waterloo on 2025-12-17.