Otago Exercise Program for Fall Prevention

Overseen By Vallabh Shah, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of New Mexico

Disqualifiers: Terminal cancer, Dialysis, Mini-Cog 0-1, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 12 months

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Otago Exercise Program for fall prevention?

Research shows that the Otago Exercise Program, which focuses on strength and balance exercises, can reduce falls by 35% among high-risk older adults. It is designed to be delivered at home by physical therapists and has been effective in decreasing falls and fall risks in both community and assisted living settings. ^{1 2 3 4 5}

Is the Otago Exercise Program safe for humans?

The Otago Exercise Program is generally considered safe for older adults, as it is a strength and balance training program designed to prevent falls. Studies have shown improvements in physical performance and balance without mentioning any significant safety concerns. ^{1 3 6 7 8}

How is the Otago Exercise Program treatment different from other treatments for fall prevention?

The Otago Exercise Program is unique because it is a home-based exercise program specifically designed to improve strength and balance, which helps prevent falls in older adults. Unlike other treatments, it can be delivered through various models, including in-person visits by physical therapists or via a DVD for those in rural areas, making it accessible and adaptable to different living situations. ^{1 2 3 5 9}

Eligibility Criteria

This trial is for Zuni tribal members aged 65 or older with a high risk of falling, determined by specific tests like the Timed Up and Go or past fall history. It's not for those with terminal cancer, on dialysis, severe cognitive impairment, unwilling to consent, unable to walk even with help, or who are legally blind.

Inclusion Criteria

I am a Zuni tribal member, 65 or older, with a high risk of falling.

Exclusion Criteria

You are excluded from the study if you have recently been diagnosed with terminal cancer, currently undergoing dialysis, have severe cognitive impairment, don't want to participate, can't walk even with assistance, or have severe vision loss.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Otago Exercise Program or education-based fall risk management over 12 months

12 months

10 home visits (OEP group), 6 home visits (Education group)

Follow-up

Participants are monitored for changes in strength, balance, and fall risk

12 months

Monthly monitoring

Treatment Details

Interventions

• Otago Exercise Program

Trial Overview The study tests the Otago Exercise Program delivered by Community Health Representatives in Zuni Pueblo. The goal is to see if this program can reduce falls among elders by improving their physical condition through exercises tailored to prevent falls.

Participant Groups

Group I: Otago Exercise Program Experimental Treatment 1 Intervention

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.

Group II: Education Active Control 1 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

Otago Exercise Program is already approved in United States for the following indications:

Approved in United States as Otago Exercise Program for:

• Fall prevention in older adults
• Used in research studies for fall prevention in tribal communities

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

Findings from Research

The Otago exercise programme (OEP) significantly reduces the risk of death in older adults (aged 65+) living in the community, with a risk ratio of 0.45 over 12 months based on a review of seven trials involving 1503 participants.

The OEP also significantly lowers fall rates, with an incidence rate ratio of 0.68, indicating it is effective in preventing falls, although it does not significantly reduce the risk of serious injuries from falls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the 'Otago exercise programme' reduce mortality and falls in older adults?: a systematic review and meta-analysis. Thomas, S., Mackintosh, S., Halbert, J.[2022]

The Otago exercise program significantly reduced the average number of falls among 30 older adults in assisted living, from 1.4 falls per person per year to 0.5 falls after the intervention.

Participants also showed a notable improvement in mobility, with Tinetti POMA scores increasing from 11.8 to 17.6, indicating enhanced balance and strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the Effects of an Otago-Based Home Exercise Program on Falls and Fall Risks in an Assisted Living Facility. Beato, M., Dawson, N., Svien, L., et al.[2020]

The Otago exercise program (OEP) significantly improved physical performance and functional capacity in elderly participants, as evidenced by better scores in balance and mobility tests after six months of training.

OEP also led to a significant reduction in the incidence of falls among seniors with a history of falls, making it an effective home-based intervention for fall prevention in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Control Trials on Otago Exercise Program (OEP) to Reduce Falls Among Elderly Community Dwellers in Shahroud, Iran. Dadgari, A., Aizan Hamid, T., Hakim, MN., et al.[2022]

The Otago Exercise Program (OEP) significantly improves physical function and reduces fall risk among older adults, with a study involving 239 participants showing positive outcomes after 6 months.

Innovative delivery models using Certified Occupational Therapy Assistants and exercise physiologists, rather than solely physical therapists, can effectively implement the OEP, potentially making it more accessible and resource-efficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Otago Exercise Program: Innovative Delivery Models to Maximize Sustained Outcomes for High Risk, Homebound Older Adults. Shubert, TE., Goto, LS., Smith, ML., et al.[2022]

The Otago Exercise Program (OEP) can be effectively delivered through alternative models, such as the community OEP, which showed similar improvements in physical function compared to the traditional US OEP model, despite being implemented by non-physical therapists.

Participants in the community OEP experienced greater improvements in the Timed 'Up & Go' Test, suggesting that the exercise component is crucial for enhancing mobility and reducing fall risk, regardless of the delivery model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Otago Exercise Program in the United States: Comparison of 2 Implementation Models. Shubert, TE., Smith, ML., Goto, L., et al.[2022]

The Otago Exercise Program (OEP) significantly improved functional mobility and balance in 210 older adults over an 8-week period, as evidenced by dramatic improvements in tests like the Timed Up-and-Go and 30-Second Chair Rise (p < .001).

Participants reported enhanced self-perceived functional performance, indicating that the OEP is effective not only in objective measures but also in how older adults feel about their mobility and balance after the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disseminating the Otago Exercise Program in the United States: Perceived and Actual Physical Performance Improvements From Participants. Shubert, TE., Smith, ML., Jiang, L., et al.[2021]

The Otago Exercise Program (OEP) significantly improves cognitive function, lower limb strength, and balance in older adults, which helps enhance gait stability and posture control, ultimately reducing the risk of falls.

OEP not only aids in preventing falls but also helps older adults overcome the fear of falling, promoting a positive attitude towards exercise and improving overall wellbeing, despite the unclear neural mechanisms behind its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of Otago exercise programme on the prevention of falls in older adult: A systematic review. Yang, Y., Wang, K., Liu, H., et al.[2023]

The Otago Exercise Programme (OEP) significantly improves various aspects of balance, including static, dynamic, and proactive balance, as well as enhancing balance confidence and reducing fear of falling in older adults, based on a meta-analysis of 12 randomized controlled trials.

Group sessions of the OEP lasting more than 30 minutes are particularly effective for improving balance performance and perceived balance ability compared to shorter sessions or individual formats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of the Otago Exercise Programme on actual and perceived balance in older adults: A meta-analysis. Chiu, HL., Yeh, TT., Lo, YT., et al.[2021]

The Otago Exercise Program (OEP) delivered via DVD is a useful tool for older adults to reduce falls, but participants found it too slow and low-energy for long-term engagement, indicating a need for more dynamic content.

While the program offers flexibility, personal health issues and daily life challenges hinder adherence, highlighting the importance of social support and motivation in maintaining an exercise routine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the Experiences of Rural Community-Dwelling Older Adults in Using a New DVD-Delivered Otago Exercise Program: A Qualitative Study. Agha, A., Liu-Ambrose, TY., Backman, CL., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Does the 'Otago exercise programme' reduce mortality and falls in older adults?: a systematic review and meta-analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Examining the Effects of an Otago-Based Home Exercise Program on Falls and Fall Risks in an Assisted Living Facility. [2020]

3. Estonia pubmed.ncbi.nlm.nih.gov

Randomized Control Trials on Otago Exercise Program (OEP) to Reduce Falls Among Elderly Community Dwellers in Shahroud, Iran. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Otago Exercise Program: Innovative Delivery Models to Maximize Sustained Outcomes for High Risk, Homebound Older Adults. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Otago Exercise Program in the United States: Comparison of 2 Implementation Models. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Disseminating the Otago Exercise Program in the United States: Perceived and Actual Physical Performance Improvements From Participants. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The impact of Otago exercise programme on the prevention of falls in older adult: A systematic review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The effects of the Otago Exercise Programme on actual and perceived balance in older adults: A meta-analysis. [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

Understanding the Experiences of Rural Community-Dwelling Older Adults in Using a New DVD-Delivered Otago Exercise Program: A Qualitative Study. [2023]