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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if doing specific exercises at home can help older adults with mild cognitive issues who have broken their hip from a fall. The goal is to see if these exercises can make them stronger and better at balancing to prevent future falls.

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 data supports the effectiveness of the Otago Exercise Program treatment for reducing fall risk after hip fracture?

Research shows that the Otago Exercise Program, which focuses on strength and balance exercises, effectively reduces falls in older adults living in the community and improves limb function and walking ability in elderly patients recovering from hip surgery. ^{1 2 3 4 5}

Is the Otago Exercise Program safe for humans?

The Otago Exercise Program is generally safe for older adults, as it is a home-based exercise program designed to improve strength and balance, reducing the risk of falls. ^{1 2 5 6 7}

How is the Otago Exercise Program treatment different from other treatments for reducing fall risk after hip fracture?

The Otago Exercise Program is unique because it is a home-based exercise program focused on improving strength, balance, and walking to prevent falls, specifically tailored for older adults. Unlike other treatments, it can be delivered through a DVD for minimal supervision, making it accessible for those in rural or assisted living settings. ^{1 2 5 8 9}

Research Team

Jennifer C Davis, PhD

Principal Investigator

University of British Columbia

Deborha Jehu, PhD

Principal Investigator

University of British Columbia

Larry Dian, MD

Principal Investigator

University of British Columbia

Teresa Liu-Ambrose, PhD

Principal Investigator

University of British Columbia

Pierre Guy, MD

Principal Investigator

University of British Columbia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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) 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) 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]

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 (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]

References

1. 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]

2. 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]

3. China pubmed.ncbi.nlm.nih.gov

Effect of Otago exercise programme on limb function recovery in elderly patients with hip arthroplasty for femoral neck fracture. [2023]

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

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

5. 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]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

7. Australia pubmed.ncbi.nlm.nih.gov

Home care worker-supported exercise program to address falls: a feasibility study. [2023]

8. 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]

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

Effects of Otago Exercise Program on postural control ability in elders living in the nursing home: A systematic review and meta-analysis. [2023]