OTAGO Exercises for Preventing Falls

(ReabFalls Trial)

Overseen By Rubens da Silva, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Université du Québec à Chicoutimi

Disqualifiers: Cancer, Severe psychiatric disorders, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

92 Participants Needed

Trial Summary

What is the purpose of this trial?

Accidental falls in older adults are one of the world's major pubic health problem, because of their strong association with injuries and mortality rates. In Quebec, falls are responsible for a high rate of hospitalization (more than 1800 emergency department visits every day) and deaths (more than 10,000 in recent years). Preventing falls is therefore a key mission for health professionals. This research program aims to develop a new clinical approach to the rehabilitation management of the older with a neuro-musculoskeletal disorder and a risk of falling. This program is part of a new partnership project between UQAC and specialized geriatric services at the CIUSSS Saguenay-Lac-St-Jean (La Baie site). These geriatric services admit more than 400 new patients per year, representing a large pool of participants for the new program's development. Specifically, this program has 4 phases: 1) Create a clinical profile of patients in rehabilitation care from specialized geriatric services (ex: reasons for consultation, neuro-musculoskeletal disorders, rates and causes of falls, etc.); 2) to diagnose functional deficits of these patients on different dimensions of functional and physical evaluations, using standardized tests and high-tech instruments (ex: platform of force); 3) determine the effectiveness of a new exercise intervention program (OTAGO) for falls prevention; and 4) Measure client and professional team satisfaction as well as long-term impact of this new approach used to prevent falls. The most significant impact of this new program will be to reduce public health expenditure for care of older adults with balance disorder and risk for falls; and therefore, be implanted in other CIUSSS institutions from Quebec.

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 OTAGO exercises treatment for preventing falls?

Research shows that the Otago Exercise Program (OEP) can reduce falls by 35% among high-risk older adults, and it has been effective in improving physical function, mood, and social participation, helping seniors live longer at home. ^{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 well-established exercise program designed to prevent falls and improve physical function, mood, and social participation. ^{1 2 4 6 7}

How is the Otago Exercise Program treatment different from other treatments for preventing falls?

The Otago Exercise Program is unique because it is a home-based exercise program specifically designed to improve strength and balance, reducing falls by 35% among high-risk older adults. Unlike other treatments, it can be delivered by physical therapists in the home or through innovative models like DVDs for rural communities, making it accessible and adaptable to different settings. ^{1 2 3 5 6}

Research Team

Sharlène Côté, MD

Principal Investigator

CIUSSS-SLSJ (La Baie Hospital)

Julie Bouchard, PhD

Principal Investigator

Université du Québec à Chicoutimi

Patrice Tremblay, PT

Principal Investigator

CIUSSS-SLSJ (La Baie Hospital)

Rubens da Silva

Principal Investigator

Université du Québec à Chicoutimi

Marie-Ève Langelier, MD

Principal Investigator

Université du Québec à Chicoutimi

Eligibility Criteria

This trial is for older adults with neuro-musculoskeletal disorders and a risk of falling, such as those with Parkinson's disease or chronic lower back pain. Participants should be experiencing issues that increase their chances of falls and may already be under geriatric care.

Inclusion Criteria

I can do exercises and tests to prevent falls on my own.

I am 65 years old or older.

I am admitted to La Baie Hospital for rehabilitation.

Exclusion Criteria

I was born with a spine deformity.

I had a stroke less than a week ago and am not yet stable.

I am receiving care to manage cancer symptoms.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Clinical Profile Creation

Create a clinical profile of patients in rehabilitation care from specialized geriatric services

4 weeks

Functional Deficit Diagnosis

Diagnose functional deficits using standardized tests and high-tech instruments

4 weeks

Treatment

Determine the effectiveness of the OTAGO exercise intervention program for falls prevention

12 weeks

2 visits per week (in-person)

Satisfaction and Long-term Impact Measurement

Measure client and professional team satisfaction as well as long-term impact of the new approach

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Conventional therapy
• OTAGO exercises

Trial Overview The study tests a new exercise program called OTAGO against conventional therapy to manage fall risks in the elderly. It involves creating patient profiles, diagnosing functional deficits using high-tech tools, evaluating the effectiveness of OTAGO exercises, and assessing satisfaction.

Participant Groups

Group I: Otago exercises Experimental Treatment 1 Intervention

OTAGO program - based on very specific exercises for balance, force, and muscular endurance as well as on education about the risk of falling. The program is considered as "home care" (exercises to be done at home) but will be done as a group and with supervision, at CIUSSS or from outdoor and nature intervention (recreactional parks). OTAGO session lasts for 30-40 minutes and will be done twice a week at sites with progression. The program is comprised of 5 muscle strengthening exercises and 12 postural balance exercises. Participants will also be invited to walk 2 times per week for 30 minutes (can be divided into shorter periods, for example 3 blocs of 10 minutes) from outdoor sites or recrative parks. According to each person's strength and mobility, exercises will be increased with the use of free weights (for example during squats) and/or by increasing the number of repetitions. Total duration of the program will be 3 months (i.e., a duration adapted to the site).

Group II: Conventional physiotherapy at Hospital Active Control 1 Intervention

This group will be for the conventional type of intervention already in place in geriatric services from La Baie Hospital. This therapy used for physiotherapists at site, including mobility exercices.

Conventional therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Physical Therapy for:

• Fall Prevention
• Rehabilitation for Older Adults

Approved in United States as Exercise Programs for:

• Fall Prevention
• Balance Improvement
• Strength Training

Approved in Canada as Rehabilitation Therapy for:

• Fall Prevention
• Neuro-musculoskeletal Disorders

Who Is Running the Clinical Trial?

Université du Québec à Chicoutimi

Lead Sponsor

Trials

7

Recruited

320+

Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean

Collaborator

Trials

4

Recruited

1,600+

Findings from Research

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 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 Programme (OEP) is considered applicable and beneficial by physical therapists for older adults receiving formal home care, enhancing their physical function and mood.

Physical therapists believe that the OEP not only improves self-efficacy and social participation but also supports older adults in living independently for longer periods at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative study exploring physical therapists' views on the Otago Exercise Programme for fall prevention: a stepping stone to "age in place" and to give faith in the future. Cederbom, S., Bjerk, M., Bergland, A.[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 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) was successfully adapted for American physical therapists (PTs), with modifications made to training materials to align with U.S. documentation and reimbursement practices, following feedback from 56 PTs during a pilot training.

Online training for the OEP was well-received by participants and effectively reached the target audience, although barriers such as lack of agency support and billing challenges were identified, indicating the need for further research on the program's implementation in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translation of the otago exercise program for adoption and implementation in the United States. Shubert, TE., Smith, ML., Ory, MG., et al.[2022]

References

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

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

2. 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]

3. Switzerland pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

A qualitative study exploring physical therapists' views on the Otago Exercise Programme for fall prevention: a stepping stone to "age in place" and to give faith in the future. [2022]

5. 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]

6. 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]

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

Translation of the otago exercise program for adoption and implementation in the United States. [2022]