FallNCT04876729
Standing Strong in Tribal Communities: Assessing Elder Falls Disparity
A study testing Otago Exercise Program in people with Fall, run by University of New Mexico at 1 site in United States.
Trial summary
Falls and fall-related injuries are major health risks in American Indian elders. The data showed 52 percent of Zuni elders reporting a fall during the past year, which is significantly higher than the US national average of one out of three adults older then 65 years. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall
- What is being tested?
- Otago Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2022to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Zuni tribal members aged 65 years and older who demonstrate elevated fall risk according to 2 or more of the following test outcomes: (1) Timed Up and Go >12 seconds; (2) 30 Second Chair Stand Test below age and gender norms; (3) Inability to complete the Four Stage Balance Test; (4) Four or more positive responses on the CDC Stay Independent: Check Your Risk for Falling; or (5) history of 2 or more falls during past year or one injurious fall during past year
Who cannot join
- (1)Self-reported diagnosis of terminal cancer in the last 6 months; (2) Currently on dialysis; (3) Mini-Cog score of 0 to 1; (4) Unwillingness to consent to participate; (5) Unable to walk with or without an assistive device; or (6) Legally blind.
Trial locations and contacts
1 site in 1 country.
United States1 site
Zuni Health Initiative
Zuni Pueblo, New Mexico, 87327
About this study
Official title: Zuni Health Initiative- Sub Study - Standing Strong in Tribal Communities: Assessing Elder Falls Disparity
Falls and fall-related injuries are major health risks in American Indian elders. The data showed 52 percent of Zuni elders reporting a fall during the past year, which is significantly higher than the US national average of one out of three adults older then 65 years. In partnership with Zuni Pueblo leadership and community stake holders, the feasibility will be reviewed in hopes of implementing Community Health Representative delivered fall risk screening and evidence-based Otago Exercise Program with physical therapist consultation to address lack of access to home delivered physical therapy and health disparity, as well as empower the participants to address fall risk, avert injury, and preserve aging in place within their community.
Read the detailed description
Native elders are essential to preserving the culture and history of tribal communities, but fall related injuries can jeopardize their ability to age in place. The Zuni Pueblo is geographically isolated with limited access to rehabilitative and supportive services. Home health physical therapy services are unavailable at the Pueblo. Therefore, Zuni elders must choose between leaving their community and social network for rehabilitative care or remain in the community with unmet needs, and increased risk of not regaining their prior level of function.
This study proposes to culturally tailor the traditional Physical Therapy delivered Otago Exercise Program, to evaluate its effectiveness in reducing falls risk and to empower elders and their families to engage in preventing falls in their community. Native Zuni CHRs will deliver OEP using novel consultation and telehealth with a Physical Therapist. The CHRs offer important advantage of speaking Zuni tribal language and understanding Zuni traditions, family structures, and elders' preferences for receiving health information. The investigators overall objective is to compare the effectiveness of a CHR delivered, culturally adapted OEP fall prevention program to the standard of care education based fall risk management.
The investigators disparity driven aims are:
Aim: To compare the effectiveness of the adapted OEP to an education-based fall risk management usual care program in improving strength and balance and reducing falls risk. Approach: Screen 400 Zuni elders, aged 65yrs and older, to identify 200 elders with elevated fall risk. Randomize 200 Zuni elders at risk for falls into a 6-month OEP intervention versus education-based control; Aim: To compare the effectiveness of the adapted OEP to an education-based fall risk management program in improving overall health status, self-management of daily activities, and social engagement. Approach: The SF12 Health Survey and Short Form PROMIS measures Self-Efficacy for Managing Daily Activities and Ability to Participate in Social Roles and Activities will be administered to all randomized participants, at baseline and 6 months, and during the final follow up visit at 12 months.
- Conditions
- Fall
- Being tested
- Otago Exercise Program
- Keywords
- American Indians, Zuni Indians, Falls Screening, Otago Exercise program (OEP), STEADI toolkit, Older adult, Falls Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago Exercise ProgramBehavioural
Otago Exercise program implemented including education on fall risk reduction, instruction on strength and balance exercises and walking program. Perform a home safety assessment and provide recommendations to reduce trip hazards. CHRs will engage local housing authority services to complete the modifications (such as grab bar installation). CHRs will complete approximately 10 home visits during 12 months with reassessment at 3, 6, and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Otago Exercise Program | Experimental | An individualized Otago Exercise Program will be delivered by community health representatives (CHR) in participants homes. There will be 10 home visits over a 12 month period. Receives: Behavioral: Otago Exercise Program |
| Education | No intervention | The control group will receive education on fall risk reduction. This will be delivered by the CHR with 6 home visits over 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Strength and Balance at 3 months, 6 months, and 12 months
Changes Timed Up and Go, 30 Second Chair Stand, and Four Stage Balance test
Measured: 3 months, 6 months and 12 months
Secondary outcomes (8)
Stop Elderly Accidents, Deaths and Injuries (STEADI) Stay Independent is a 12-item assessment
History of falls and other issues related to increased chance of a fall; Scale: 0-14; Higher score indicates greater falls risk
Measured: Baseline
The Attitudes to Falls-Related Interventions Scale (AFRIS)
Examines beliefs about falls prevention; Scale: 0-18; Higher score indicates more positive beliefs about falls prevention
Measured: Baseline and 12 months
Medical Outcomes Study Short Form 12 (SF-12v2)
12-item questionnaire that tests how health affects quality of life; Scale: 12-47; Higher score indicates better quality of life
Measured: Baseline, 6 months and 12 months
Falls incidence
Monthly falls calendar over 12 months
Measured: Monthly from baseline to 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Daily Activities
Measures ability to manage daily activities; Scale: 4-20; Higher score indicates greater self-efficacy to manage daily activities
Measured: Baseline, 6 months and 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities
Measures participation in the community; Scale: 4-20; Higher score indicates more difficulty participating in social roles and activities
Measured: Baseline, 6 months and 12 months
Clinical Characteristics
Anthropological Measurement (Ht \& Wt)
Measured: Baseline and 12 months
Clinical Characteristics
Blood Pressure
Measured: Baseline, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start16 Aug 2022
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FallStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vallabh O Shah, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876729
- Sponsor's protocol ID
- 21-261 -Falls study
- Status last verified
- Aug 2025
- First submitted
- 3 May 2021
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Waters DL, Popp J, Herman C, Ghahate D, Bobelu J, Pankratz VS, Shah VO. The Otago Exercise Program compared to falls prevention education in Zuni elders: a randomized controlled trial. BMC Geriatr. 2022 Aug 9;22(1):652. doi: 10.1186/s12877-022-03335-6.
PubMed 35945496
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zuni Health Initiative- Sub Study - Standing Strong in Tribal Communities: Assessing Elder Falls Disparity
- ClinicalTrials.gov ID
- NCT04876729
- Acronym / sponsor ID
- 21-261 -Falls study
- Conditions
- Fall
- Keywords
- American Indians, Zuni Indians, Falls Screening, Otago Exercise program (OEP), STEADI toolkit, Older adult, Falls Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 6 May 2021 (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.
Falls and fall-related injuries are major health risks in American Indian elders. The data showed 52 percent of Zuni elders reporting a fall during the past year, which is significantly higher than the US national average of one out of three adults older then 65 years. In partnership with Zuni Pueblo leadership and community stake holders, the feasibility will be reviewed in hopes of implementing Community Health Representative delivered fall risk screening and evidence-based Otago Exercise Program with physical therapist consultation to address lack of access to home delivered physical therapy and health disparity, as well as empower the participants to address fall risk, avert injury, and preserve aging in place within their community.
Detailed description
Native elders are essential to preserving the culture and history of tribal communities, but fall related injuries can jeopardize their ability to age in place. The Zuni Pueblo is geographically isolated with limited access to rehabilitative and supportive services. Home health physical therapy services are unavailable at the Pueblo. Therefore, Zuni elders must choose between leaving their community and social network for rehabilitative care or remain in the community with unmet needs, and increased risk of not regaining their prior level of function.
This study proposes to culturally tailor the traditional Physical Therapy delivered Otago Exercise Program, to evaluate its effectiveness in reducing falls risk and to empower elders and their families to engage in preventing falls in their community. Native Zuni CHRs will deliver OEP using novel consultation and telehealth with a Physical Therapist. The CHRs offer important advantage of speaking Zuni tribal language and understanding Zuni traditions, family structures, and elders' preferences for receiving health information. The investigators overall objective is to compare the effectiveness of a CHR delivered, culturally adapted OEP fall prevention program to the standard of care education based fall risk management.
The investigators disparity driven aims are:
Aim: To compare the effectiveness of the adapted OEP to an education-based fall risk management usual care program in improving strength and balance and reducing falls risk. Approach: Screen 400 Zuni elders, aged 65yrs and older, to identify 200 elders with elevated fall risk. Randomize 200 Zuni elders at risk for falls into a 6-month OEP intervention versus education-based control; Aim: To compare the effectiveness of the adapted OEP to an education-based fall risk management program in improving overall health status, self-management of daily activities, and social engagement. Approach: The SF12 Health Survey and Short Form PROMIS measures Self-Efficacy for Managing Daily Activities and Ability to Participate in Social Roles and Activities will be administered to all randomized participants, at baseline and 6 months, and during the final follow up visit at 12 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Otago Exercise Program | Experimental | Behavioral: Otago Exercise ProgramAn individualized Otago Exercise Program will be delivered by community health representatives (CHR) in participants homes. There will be 10 home visits over a 12 month period. |
| Education | No intervention | –The control group will receive education on fall risk reduction. This will be delivered by the CHR with 6 home visits over 12 months |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Zuni tribal members aged 65 years and older who demonstrate elevated fall risk according to 2 or more of the following test outcomes: (1) Timed Up and Go >12 seconds; (2) 30 Second Chair Stand Test below age and gender norms; (3) Inability to complete the Four Stage Balance Test; (4) Four or more positive responses on the CDC Stay Independent: Check Your Risk for Falling; or (5) history of 2 or more falls during past year or one injurious fall during past year
Key exclusion criteria (1 listed)
- (1)Self-reported diagnosis of terminal cancer in the last 6 months; (2) Currently on dialysis; (3) Mini-Cog score of 0 to 1; (4) Unwillingness to consent to participate; (5) Unable to walk with or without an assistive device; or (6) Legally blind.
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 ProgramOtago Exercise program implemented including education on fall risk reduction, instruction on strength and balance exercises and walking program. Perform a home safety assessment and provide recommendations to reduce trip hazards. CHRs will engage local housing authority services to complete the modifications (such as grab bar installation). CHRs will complete approximately 10 home visits during 12 months with reassessment at 3, 6, and 12 months. | Behavioural | Otago Exercise Program |
Primary outcome
Changes in Strength and Balance at 3 months, 6 months, and 12 months
Time frame: 3 months, 6 months and 12 months
Changes Timed Up and Go, 30 Second Chair Stand, and Four Stage Balance test
8 secondary outcomes
Stop Elderly Accidents, Deaths and Injuries (STEADI) Stay Independent is a 12-item assessment
Time frame: Baseline
The Attitudes to Falls-Related Interventions Scale (AFRIS)
Time frame: Baseline and 12 months
Medical Outcomes Study Short Form 12 (SF-12v2)
Time frame: Baseline, 6 months and 12 months
Falls incidence
Time frame: Monthly from baseline to 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Daily Activities
Time frame: Baseline, 6 months and 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities
Time frame: Baseline, 6 months and 12 months
Clinical Characteristics
Time frame: Baseline and 12 months
Clinical Characteristics
Time frame: Baseline, 3 months, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Derived from this study: PubMed 35945496Waters DL, Popp J, Herman C, Ghahate D, Bobelu J, Pankratz VS, Shah VO. The Otago Exercise Program compared to falls prevention education in Zuni elders: a randomized controlled trial. BMC Geriatr. 2022 Aug 9;22(1):652. doi: 10.1186/s12877-022-03335-6.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Fall, run by University of New Mexico 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 2 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Strength and Balance at 3 months, 6 months, and 12 months (time frame: 3 months, 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04876729, which also lists 1 linked publication.
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 2 Sep 2025.