Otago Exercise Program for Fall Risk Reduction After Hip Fracture

Overseen By Teresa Liu-Ambrose, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must be taking: Anti-dementia

Disqualifiers: Neurodegenerative disease, Stroke, 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: 2

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a home-based exercise program, the Otago Exercise Program, in reducing falls among older adults. It targets individuals who have experienced a hip fracture from a fall and have mild memory problems. The trial compares regular medical care with and without the addition of these exercises, which focus on improving strength and balance. Individuals aged 65 or older, who have had a hip fracture due to a fall and experience memory issues, may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance fall prevention strategies for older adults.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on anti-dementia medications, you should be stable on a fixed dose for more than 3 months before joining the trial.

What prior data suggests that the Otago Exercise Program is safe for reducing fall risk in older adults with mild cognitive impairment?

Research shows that the Otago Exercise Program (OEP) is safe and manageable for participants. Studies have found that OEP not only strengthens muscles in individuals who have experienced falls or strokes but also significantly lowers the risk of falling. For those who performed the exercises, falls decreased by 30% to 66% compared to those who did not. This indicates that the program is effective without causing major side effects.

The program is particularly beneficial for older adults, including those over 80. Both men and women benefit equally, and evidence suggests it even reduces the risk of death for older adults living in the community.

Overall, the evidence supports that the Otago Exercise Program is safe and effective in reducing fall risks among older adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Otago Exercise Program because it offers a unique approach to reducing fall risk after hip fractures. Unlike standard care, which typically involves periodic visits to a geriatrician, this program adds an individualized, home-based exercise regimen focused on strength and balance training. Delivered by a physical therapist, the program is designed to be progressive, meaning it adapts and intensifies as participants build their capabilities. This tailored and proactive method could empower patients to regain mobility and confidence more effectively than traditional treatments alone.

What evidence suggests that the Otago Exercise Program is effective for reducing fall risk in older adults with mild cognitive impairment and a fall-related hip fracture?

Research has shown that the Otago Exercise Program (OEP), which participants in this trial may receive, helps lower the risk of falls in older adults. Studies found that injuries from falls dropped by 28% after one year of these exercises. The program includes exercises to build strength and improve balance, both crucial for preventing falls. Strong evidence supports its effectiveness, especially for individuals with conditions like osteoarthritis, which share risk factors with hip fractures. Overall, the OEP offers a promising way to boost physical fitness and reduce the risk of falls in older people. ^{1 3 6 7 8}

Who Is on the Research Team?

Teresa Liu-Ambrose, PhD

Principal Investigator

University of British Columbia

Larry Dian, MD

Principal Investigator

University of British Columbia

Jennifer C Davis, PhD

Principal Investigator

University of British Columbia

Deborha Jehu, PhD

Principal Investigator

University of British Columbia

Pierre Guy, MD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for adults aged 65 or older who have had a fall-related hip fracture within the last year, can walk a short distance with or without help, and have mild cognitive issues but no dementia. They must be able to communicate in English and not be on certain dementia medications.

Inclusion Criteria

Have preserved general cognition as indicated by a Mini-Mental State Examination (MMSE) score > 24/30

Have subjective memory complaints, determined by interview

You broke your hip from a fall in the past year and have since returned home.

Exclusion Criteria

You have a history of fainting due to sensitivity in your carotid sinus.

You have had a stroke.

You have been diagnosed with or suspected to have a disease that affects your brain and memory, such as Parkinson's or dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Otago Exercise Program or usual care for 6 months

6 months

2 visits (in-person) at baseline and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Otago Exercise Program
• Usual Care

Trial Overview The study tests if the Otago Exercise Program (a home-based exercise routine) is better than usual care at reducing the risk of falls among older adults with mild cognitive impairment after they've suffered a hip fracture.

How Is the Trial Designed?

Group I: Usual Care with Exercise Experimental Treatment 2 Interventions

Clinical care provided by geriatricians. Each participant will see the geriatrician at baseline and 6 months. In addition, they will receive the Otago Exercise Program, an individualized and home-based program of progressive strength and balance training exercises delivered by a physical therapist.

Group II: Usual Care Active Control 1 Intervention

Clinical care provided by geriatricians. Each participant will see the geriatrician at baseline and 6 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 British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Amgen

Industry Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Published Research Related to This Trial

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 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 (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 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 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) 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9631473/

The impact of Otago exercise programme on ... Although OEP has significant positive effects on improving the health and physical fitness of older adult, preventing falls, and restoring clinical function, ...

2. bmcnurs.biomedcentral.com bmcnurs.biomedcentral.com/articles/10.1186/s12912-024-02310-3

Efficacy of the Otago-Exercise-Programme to reduce falls in ... The Otago Exercise Programme is an effective intervention for falls prevention. However, there is limited evidence in relation to studies ...

3. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1522952/full

The Otago Exercise Program's effect on fall prevention High-quality evidence supports the effectiveness of the Otago Exercise Program in reducing fall risk among individuals with osteoarthritis (OA) (46). ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10233327/

The effect of an exercise-based rehabilitation programme ... A large number of RCTs have investigated the effects of simple home-based exercise programmes, such as the Otago Exercise Programme, to prevent falls, to reduce ...

5. physio-pedia.com physio-pedia.com/Otago_Exercise_Programme

Otago Exercise Programme After one year, injuries due to falls were reduced by 28% in participants performing Otago exercises. The Otago exercise program was most effective at reducing ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12172654/

The Otago Exercise Program's effect on fall prevention High-quality evidence supports the effectiveness of the Otago Exercise Program in reducing fall risk among individuals with osteoarthritis (OA) (46). ...

7. med.unc.edu med.unc.edu/aging/cgwep/wp-content/uploads/sites/865/2024/04/Otago-Guide-for-PT_April-2024-update.pdf

Tools to Implement the Otago Exercise Program The program was most effective for adults 80 years and older. Men and women benefited equally.

8. withpower.com withpower.com/trial/phase-fractures-bone-4-2021-7491c

Otago Exercise Program for Fall Risk Reduction After Hip ... 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 ...