OsteoporosisVIVANCT07288684
Chiropractor Delivered Virtual Intervention After Vertebral frActure
A study testing VIVA in people with Osteoporosis and Vertebral Fracture, run by University of Waterloo at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis, Vertebral Fracture
- What is being tested?
- VIVA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 20 Oct 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lora Giangregorio, PhD contact
Canada1 site, 1 recruiting
- Recruiting
University of Waterloo
Waterloo, Ontario, N2L3G1
Allison A Legg, 2893800859, a2legg@uwaterloo.ca
Lora Giangregorio, PhD, lora.giangregorio@uwaterloo.ca
About this study
Official title: Chiropractor Delivered Virtual Intervention After Vertebral frActure (VIVA)
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.
Read more
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%.
Read the detailed description
Spine fractures are the most common fracture due to osteoporosis. They can happen because of falls or activities of daily life like bending and lifting. Fractures of the spine can result in pain, which can last for a long time. Spine fractures can affect breathing, appetite, digestion, and mobility, and can restrict or modify an individuals' work or daily activities.
There are no standard rehabilitation programs after spine fracture, and patients often must pay out of pocket for rehabilitation. Rehabilitation can be hard to access (especially in rural or remote locations) and it can be difficult to find providers with training and expertise to treat spine fractures.
Our team includes Osteoporosis Canada, patients, health care professionals, and researchers from multiple provinces. We reviewed research, consulted patients and healthcare providers to understand their experiences with spine fracture rehabilitation to develop a Toolkit for a virtual rehabilitation program for people with spine fracture, called 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. We used the Behavior Change Wheel method to select four implementation strategies: education on pain management, safe movement, exercise, and nutrition; modeling of and training on exercises, safe movement, and pain management strategies; and enablement, such as goal setting, action planning, and self-monitoring.
Participants receive a technology consultation 1-2 weeks prior to baseline assessment, and receive intervention in week one (immediately post-randomization) or in week ten (waitlist control). A provider completes a virtual assessment, and then leads 1:1 once-weekly 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.
The provider prescribes resources (e.g., summaries, pictures, videos) using the Wibbi app (https://wibbi.com/) 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. The first session will serve as an intake session.
Depending on the patient needs the provider either will provide training on exercises, movement tips, or pain management tips. Finally, the provider will show how to monitor performance and adherence throughout the intervention, discuss and decide on the area of focus for the next session (i.e., pain management, safe movement, exercise, nutrition), and schedule the next session.
The remaining 11 sessions from Week 2 to Week 8 will start with education on the chosen topic. The provider will review progress on exercises, movement strategies, or pain management tips from the previous sessions and demonstrate new exercises or strategies. The provider will deliver the exercises prescribed and any educational resources through the Wibbi app and decide on an area of focus for the next session based on discussion with the participant.
VIVA was designed and user tested in the context of physiotherapist delivery, but chiropractors may be well-situated to deliver VIVA. Chiropractors and physiotherapists manage similar patient bases with overlapping scopes of practice. We propose a pilot study of the feasibility of the implementation of the VIVA Toolkit with a chiropractor as the provider (i.e., Can we recruit people? Do they like the program? Do they attend?). Through this study we will also collect information about pain, quality of life and physical functioning before and after the intervention. We will then use the findings of this study to determine if it is feasible to include chiropractor providers in a larger clinical trial.
- Conditions
- Osteoporosis, Vertebral Fracture
- Being tested
- VIVA
- Keywords
- Rehabilitation
- Medical subject headings
- Osteoporosis, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIVABehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Receipt of VIVA | Experimental | 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. Receives: Behavioral: VIVA |
| Control | No intervention | Participants receive a technology consultation 1-2 weeks prior to baseline assessment, and receive intervention in week ten (waitlist control). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Chiropractic Delivery
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%.
Measured: We will consider ≥80% retention at 20 weeks acceptable. Adherence will be defined as ≥2 sessions per week of exercise at 20 weeks
Secondary outcomes (7)
Participant experience
We will lead exit interviews using an interview guide with open-ended questions guided by user-centred design principles.
Measured: At completion of 10 weeks.
Pain and Quality of Life
Using the QUALEFFO-41 to measure health-related quality of life, the QUALEFFO-41 also includes questions on pain.
Measured: Will be measured at weeks 10/20 (effectiveness) and 20 weeks (sustainability, immediate group only
Health-Related Quality of life
We will use the EuroQOL instrument (EQ5D5L) to measure health-related quality of life
Measured: Will be measured at weeks 10/20 (effectiveness) and 20 weeks (sustainability, immediate group only
Physical Performance - Balance
We will assess static balance via three point balance scale from the Short Physical Performance Battery.
Scoring:
- Side-by-side-stand Held for 10 sec ❒ 1 point Not held for 10 sec ❒ 0 points Not attempted ❒ 0 points
Number of seconds held if less than 10 sec: _______ sec *If 0 points, end Balance Tests
- Semi-Tandem Stand Held for 10 sec ❒ 1 point Not held for 10 sec ❒ 0 points Not attempted ❒ 0 points
Number of seconds held if less than 10 sec: _______ sec *If 0 points, end Balance Tests
- Tandem Stand Held for 10 sec ❒ 2 points Held for 3 to 9.99 sec ❒ 1 point Held for < than 3 sec ❒ 0 points Not attempted ❒ 0 points (circle reason above)
Measured: Physical performance will be measured at weeks 10/20 (effectiveness) and 20 (sustainability, immediate group only).
Physical Performance - Sit to Stand Performance
We will assess sit-to-stand performance (30 Second Chair Stand Test).
Test Instructions With your shoes on, complete as many repetitions as you can safely and at your own pace.
Single Chair Stand (Practice)
- Sit in the middle of the chair.
- Keep your feet flat on the floor, hip width apart.
- Keep your back straight and hold your arms across the chest.
- Rise to a full standing position, then sit back down again.
- If you are able to complete one repetition safely, proceed with the full test on the next page. If not, this is the end of the test.
Scoring: 30s Chair Stand Test AGE Men Women 60-64 < 14 < 12 65-69 < 12 < 11 70-74 < 12 < 10 75-79 < 11 < 10 80-84 < 10 < 9 85-89 < 8 < 8 90-94 < 7. < 4
Measured: Physical performance will be measured at weeks 10/20 (effectiveness) and 20 (sustainability, immediate group only)
Adherence to diet recommendations
Protein, calcium, vitamin D and energy intake will be measured with ASA24 and compared to Health Canada recommended dietary allowances.
Measured: Measured at 20 weeks, immediate group only
Adverse events
We will ask participants to report adverse events, defined using Health Canada definitions and established protocols. We will report all serious and non-serious adverse events (including falls, fractures) and identify them as: a) Expected/Unexpected and b) Related/unrelated to the intervention program.
Participants instructed to inform chiropractor if they have an adverse event. "If you have an illness, injury, or need to get medical help, whether it is due to study participation or not, please contact us." During the week 10 and week 20 assessments, assessors to inquire about whether the participant had any illnesses or injuries.
Measured: On-going, disclosed during intervention sessions, or at assessment milestones (week 10 and 20).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start20 Oct 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- We will conduct a pragmatic, pilot trial with two parallel groups with a 1:1 ratio. Participants will be randomized to: 1) immediate receipt of VIVA intervention; or 2) waitlist usual care control and delayed receipt of VIVA 10 weeks post-randomization.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Chiropractic Research Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288684
- Sponsor's protocol ID
- CTO 4816
- Acronym
- VIVA
- Status last verified
- Oct 2025
- First submitted
- 16 Jul 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chiropractor Delivered Virtual Intervention After Vertebral frActure (VIVA)
- ClinicalTrials.gov ID
- NCT07288684
- Acronym / sponsor ID
- VIVA / CTO 4816
- Conditions
- Osteoporosis, Vertebral Fracture
- Keywords
- Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Canadian Chiropractic Research Foundation
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Detailed description
Spine fractures are the most common fracture due to osteoporosis. They can happen because of falls or activities of daily life like bending and lifting. Fractures of the spine can result in pain, which can last for a long time. Spine fractures can affect breathing, appetite, digestion, and mobility, and can restrict or modify an individuals' work or daily activities.
There are no standard rehabilitation programs after spine fracture, and patients often must pay out of pocket for rehabilitation. Rehabilitation can be hard to access (especially in rural or remote locations) and it can be difficult to find providers with training and expertise to treat spine fractures.
Our team includes Osteoporosis Canada, patients, health care professionals, and researchers from multiple provinces. We reviewed research, consulted patients and healthcare providers to understand their experiences with spine fracture rehabilitation to develop a Toolkit for a virtual rehabilitation program for people with spine fracture, called 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. We used the Behavior Change Wheel method to select four implementation strategies: education on pain management, safe movement, exercise, and nutrition; modeling of and training on exercises, safe movement, and pain management strategies; and enablement, such as goal setting, action planning, and self-monitoring.
Participants receive a technology consultation 1-2 weeks prior to baseline assessment, and receive intervention in week one (immediately post-randomization) or in week ten (waitlist control). A provider completes a virtual assessment, and then leads 1:1 once-weekly 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.
The provider prescribes resources (e.g., summaries, pictures, videos) using the Wibbi app (https://wibbi.com/) 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. The first session will serve as an intake session.
Depending on the patient needs the provider either will provide training on exercises, movement tips, or pain management tips. Finally, the provider will show how to monitor performance and adherence throughout the intervention, discuss and decide on the area of focus for the next session (i.e., pain management, safe movement, exercise, nutrition), and schedule the next session.
The remaining 11 sessions from Week 2 to Week 8 will start with education on the chosen topic. The provider will review progress on exercises, movement strategies, or pain management tips from the previous sessions and demonstrate new exercises or strategies. The provider will deliver the exercises prescribed and any educational resources through the Wibbi app and decide on an area of focus for the next session based on discussion with the participant.
VIVA was designed and user tested in the context of physiotherapist delivery, but chiropractors may be well-situated to deliver VIVA. Chiropractors and physiotherapists manage similar patient bases with overlapping scopes of practice. We propose a pilot study of the feasibility of the implementation of the VIVA Toolkit with a chiropractor as the provider (i.e., Can we recruit people? Do they like the program? Do they attend?). Through this study we will also collect information about pain, quality of life and physical functioning before and after the intervention. We will then use the findings of this study to determine if it is feasible to include chiropractor providers in a larger clinical trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- We will conduct a pragmatic, pilot trial with two parallel groups with a 1:1 ratio. Participants will be randomized to: 1) immediate receipt of VIVA intervention; or 2) waitlist usual care control and delayed receipt of VIVA 10 weeks post-randomization.
| Arm | Type | Receives |
|---|---|---|
| Immediate Receipt of VIVA | Experimental | Behavioral: VIVAParticipants 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. |
| Control | No intervention | –Participants receive a technology consultation 1-2 weeks prior to baseline assessment, and receive intervention in week ten (waitlist control). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIVAVIVA 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. | Behavioural | Immediate Receipt of VIVA |
Primary outcome
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
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%.
7 secondary outcomes
Participant experience
Time frame: At completion of 10 weeks.
Pain and Quality of Life
Time frame: Will be measured at weeks 10/20 (effectiveness) and 20 weeks (sustainability, immediate group only
Health-Related Quality of life
Time frame: Will be measured at weeks 10/20 (effectiveness) and 20 weeks (sustainability, immediate group only
Physical Performance - Balance
Time frame: Physical performance will be measured at weeks 10/20 (effectiveness) and 20 (sustainability, immediate group only).
Physical Performance - Sit to Stand Performance
Time frame: Physical performance will be measured at weeks 10/20 (effectiveness) and 20 (sustainability, immediate group only)
Adherence to diet recommendations
Time frame: Measured at 20 weeks, immediate group only
Adverse events
Time frame: On-going, disclosed during intervention sessions, or at assessment milestones (week 10 and 20).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lora Giangregorio, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIVA in people with Osteoporosis and Vertebral Fracture, run by University of Waterloo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allison A Legg (289-380-0859, a2legg@uwaterloo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025; AzTrials last refreshed its copy on 1 Nov 2026.