Fall Risk FactorsNCT06931067
OTAGO Exercise Program and Motivational Interviewing
A study testing OTAGO Exercise Program with motivational interviewing in people with Fall Risk Factors and Physical Activity, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The goal of this study is to see if OTAGO instructors, who have been trained in a special communication method called motivational interviewing, can help older adults start and stick with the OTAGO exercise program. Read more about this study
- Who is it for?
- Ages 60 to 120 years
- Conditions the study is for
- Fall Risk Factors, Physical Activity, Engagement, Patient
- What is being tested?
- OTAGO Exercise Program with motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2025to Feb 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 60 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥60
- At high fall risk: At least one "Yes" to 1) had a fall in the past year; 2) answer "difficult" to the question "do you find it hard to stand without using your hands"; 3) worry about falling
- Able to converse audibly and coherently in English
- Ambulatory with or without assistive device use
- Self-report challenges navigating the environment outside of the home
- At least one "some or much difficulty" or "unable to do" to:Walking one block?; Stepping up onto a curb?; Getting out of a straight back chair? Climbing one flight of stairs? Getting out of the house
Who cannot join
- o Receiving ongoing physical therapy with a primary focus on improving balance and strength of lower extremities
- Experiencing acute health issues such as fracture, pain, or infection that prohibits them from participating in exercises
- Able to stand on one foot for more than 10 seconds without holding onto something
- 6-item Callahan cognitive assessment over the phone: Patients with scores of 2 or less, positive for dementia criteria, will be excluded.
- Patients participating in other studies that may impact fall-related behavior change.
- Participants engaged in routine moderate or vigorous physical activities that require lower extremity balance and strength (e.g., >100 minutes/week for more than 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.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Health Behavior Change for Fall Prevention
The goal of this study is to see if OTAGO instructors, who have been trained in a special communication method called motivational interviewing, can help older adults start and stick with the OTAGO exercise program. The results will help guide future research on how behavior change techniques can support other fall prevention strategies.
Read the detailed description
The objective of this study is to evaluate the feasibility and impact of OTAGO instructors who are trained in motivational interviewing communication approach to facilitate older adult's uptake of the OTAGO exercises. This study will create the basis for future trials that will explore the impact of behavior change interventions on other fall prevention strategies.
We propose a single-arm quasi-experimental trial with older adults with high fall risks. The study intervention consists of OTAGO visits by study staff (MI-trained OTAGO instructor) over 6 months to improve older adults' engagement in fall prevention behaviors with a focus on OTAGO exercises. Participants will be followed for additional 6 months for the total study duration of 12 months.
- Conditions
- Fall Risk Factors, Physical Activity, Engagement, Patient, Community-dwelling Older Adults
- Being tested
- OTAGO Exercise Program with motivational interviewing
- Keywords
- OTAGO, OEP, Motivational interviewing, behavior change
- Medical subject headings
- Motor Activity, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTAGO Exercise Program with motivational interviewingBehavioural
OTAGO exercise home visits will be offered 7 times with 2 phone-based check-ins during the 6-month period. As part of OTAGO home visits, participants will receive OTAGO exercise instruction and MI. Each home visit will be approximately an hour.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | OTAGO exercise home visits will be offered 7 times with 2 phone-based check-ins during the 6-month period. As part of OTAGO home visits, participants will receive OTAGO exercise instruction and MI. Each home visit will be approximately an hour. Receives: Behavioral: OTAGO Exercise Program with motivational interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
OTAGO exercise adherence
Number of instructed OTAGO exercises completed in a week
Measured: Baseline, 6-months & 12 months
Secondary outcomes (3)
4-stage balance test
Participants are asked to hold four standing positions that get progressively harder to maintain.
- Stand with your feet side-by-side
- Place the instep of one foot so it is touching the big toe of the other foot.
- Tandem stance Place one foot in front of the other, heel touching toes
- Stand on one foot.
Measured: Baseline & 6-months
Sit-to-stand test
Participants are asked to stand from a seated position. We count the number of sit-stand-sit repetitions completed during 30 seconds
Measured: Baseline & 6-months
Falls Efficacy Scale Short International
Measures levels of concern about falls. 7-item, 4-point Likert-type scale; 28: highest concern
Measured: Baseline, 6-months, and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start20 Feb 2025
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall Risk FactorsStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Wellness Network
- Responsible party
- Principal investigator, Hiroko Kiyoshi-Teo, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931067
- Sponsor's protocol ID
- 27787
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study IPD may be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Behavior Change for Fall Prevention
- ClinicalTrials.gov ID
- NCT06931067
- Acronym / sponsor ID
- 27787
- Conditions
- Fall Risk Factors, Physical Activity, Engagement, Patient, Community-dwelling Older Adults
- Keywords
- OTAGO, OEP, Motivational interviewing, behavior change
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Oregon Wellness Network
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 16 Apr 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.
The goal of this study is to see if OTAGO instructors, who have been trained in a special communication method called motivational interviewing, can help older adults start and stick with the OTAGO exercise program. The results will help guide future research on how behavior change techniques can support other fall prevention strategies.
Detailed description
The objective of this study is to evaluate the feasibility and impact of OTAGO instructors who are trained in motivational interviewing communication approach to facilitate older adult's uptake of the OTAGO exercises. This study will create the basis for future trials that will explore the impact of behavior change interventions on other fall prevention strategies.
We propose a single-arm quasi-experimental trial with older adults with high fall risks. The study intervention consists of OTAGO visits by study staff (MI-trained OTAGO instructor) over 6 months to improve older adults' engagement in fall prevention behaviors with a focus on OTAGO exercises. Participants will be followed for additional 6 months for the total study duration of 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: OTAGO Exercise Program with motivational interviewingOTAGO exercise home visits will be offered 7 times with 2 phone-based check-ins during the 6-month period. As part of OTAGO home visits, participants will receive OTAGO exercise instruction and MI. Each home visit will be approximately an hour. |
Who may qualify
- Ages
- 60 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥60
- At high fall risk: At least one "Yes" to 1) had a fall in the past year; 2) answer "difficult" to the question "do you find it hard to stand without using your hands"; 3) worry about falling
- Able to converse audibly and coherently in English
- Ambulatory with or without assistive device use
- Self-report challenges navigating the environment outside of the home
Key exclusion criteria (6 listed)
- o Receiving ongoing physical therapy with a primary focus on improving balance and strength of lower extremities
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 |
|---|---|---|
| OTAGO Exercise Program with motivational interviewingOTAGO exercise home visits will be offered 7 times with 2 phone-based check-ins during the 6-month period. As part of OTAGO home visits, participants will receive OTAGO exercise instruction and MI. Each home visit will be approximately an hour. | Behavioural | Intervention arm |
Primary outcome
OTAGO exercise adherence
Time frame: Baseline, 6-months & 12 months
Number of instructed OTAGO exercises completed in a week
3 secondary outcomes
4-stage balance test
Time frame: Baseline & 6-months
Sit-to-stand test
Time frame: Baseline & 6-months
Falls Efficacy Scale Short International
Time frame: Baseline, 6-months, and 12-months
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 16 Apr 2025.
- Individual participant dataSharing planned: Yes. De-identified study IPD may be shared upon request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OTAGO Exercise Program with motivational interviewing in people with Fall Risk Factors and Physical Activity, run by Oregon Health and Science University at 1 site in United States.
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 6 inclusion and 6 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 16 Apr 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 United States. 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 Hiroko Kiyoshi-Teo, PhD, RN (5034943858, kiyoshi@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OTAGO exercise adherence (time frame: Baseline, 6-months & 12 months). 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 16 Apr 2025.