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Old Age; DebilityNCT04851405

Implementing an Evidence-based Exercise Program to Reduce Falls in Community-dwelling Older Adults (Otago)

A study testing Otago Exercise Programme+ (OEP+) and Otago Exercise Programme (OEP) in people with Old Age; Debility and Fall, run by University of British Columbia at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Falls are a major health care problem for seniors. The Otago Exercise Program, which consists of strength and balance training delivered by a physiotherapist, can reduce falls in this population. We will test two methods to deliver the Otago program. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Old Age; Debility, Fall
What is being tested?
Otago Exercise Programme+ (OEP+) and Otago Exercise Programme (OEP)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
35 participants
Where
1 siteCanada
Study dates
1 Sep 2021to 1 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • over 70 years of age
  • self-report a non-syncopal fall corroborated by an informant, in the previous six months
  • are able to walk three meters with or without an assistive device
  • have a Mini-Mental State Examination score > 24/30
  • have a Physiological Profile Assessment composite score of at least 1.0 standard deviation above age-normative value or have a Timed Up and Go test > 15 seconds, or had one additional non-syncopal fall in the previous 12 months
  • live in an area served by Vancouver Coastal Health
Show all 14Show fewer
  • understand, speak, and read English proficiently
  • have access to a mobile device
  • are willing to have their OEP sessions audio-recorded
  • able to provide written informed consent
  • willing to participate in training on the OEP
  • complete the BAP training
  • be audio-recorded during the OEP sessions
  • be randomized to the OEP group with coaching or without coaching

Who cannot join

  • people not meeting the criteria above
  • not willing to participate in the above criteria

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Arthritis Research Canada

    Vancouver, British Columbia, V5Y 3P2

Other trials in Canada

About this study

Official title: Implementing an Evidence-based Exercise Program to Reduce Falls in Community-dwelling Older Adults

Falls are a major health care problem for seniors. The Otago Exercise Program, which consists of strength and balance training delivered by a physiotherapist, can reduce falls in this population. We will test two methods to deliver the Otago program. These will include a new coaching approach by a physiotherapist with the use of a Fitbit to provide feedback versus the traditional delivery. The degree to which the program is delivered as intended by physiotherapists as well as the number of falls, risk of falling, and participation in walking activities in older adults will be assessed over 24 months. Lastly, we will assess if the coaching approach is a cost-effective option.

Read the detailed description

Falls are a major health care problem for older adults (i.e., those aged ≥ 65 years) and health care systems. Falls account for 50% of injury-related admissions to hospital, 40% of admissions to nursing homes, and a 10% increase in home care services. They are also the leading cause of fatal injury among Canadians over 65 years old. This represents a significant health burden. Fortunately, falls are preventable. There is strong evidence that the Otago Exercise Program (OEP), physiotherapist (PT)-led home-based exercise program of strength and balance training, is effective at preventing falls in older adults with complex medical conditions. Originally developed in New Zealand the OEP has been implemented worldwide, but adherence to the program is a challenge. We propose that the suboptimal adherence is partly due to a lack of focus on behaviour change techniques such as self-monitoring and action planning in the delivery of OEP.

The investigators will use a mixed-methods approach, involving a RCT and in-depth interviews. The delivery of OEP+ vs OEP, from PTs, and its recipients, the older adults, will be determined at random. The training for the PT's will be provided by the Centre for Collaboration Motivation \& Innovation (CCMI), a non-profit organization with a mandate to support the use of behaviour change techniques to improve health care. Prior to data collection, the PTs will attend a 2-hour workshop on the coaching protocol using the OEP app.

The goal of this project is to assess OEP+ as an implementation strategy to improve OEP delivery (by PTs) and adherence (by older adults).

Being tested
Otago Exercise Programme+ (OEP+), Otago Exercise Programme (OEP)
Keywords
Exercise, Strength Training, Fitbit
Medical subject headings
Frailty, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Otago Exercise Programme+ (OEP+)Behavioural

    Physiotherapists (PTs) will receive OEP and BAP training. They will provide at home visits and follow-up phone calls to the older adult participants (5 at home visits and 3 phone calls).

    Older adults will have access to the OEP app.

  • Otago Exercise Programme (OEP)Behavioural

    PTs will receive OEP training. They will provide at home visits and follow-up phone calls to the older adult participants (5 at home visits and 3 follow-up phone calls).

Study groups in NCT04851405
Study groupRoleWhat they receive
Otago Exercise Programme+ Intervention Group (OEP+)Active comparatorPhysiotherapists receive OEP training, a 2 hour workshop on the coaching protocol using the OEP app, and online training on the Brief Action Plan Approach with 2 telephone practice sessions with an experienced Brief Action Plan counsellor. Each PT will deliver exercise program to 8 older adults. PTs will help older adults to set-up OEP app and Fitbit. PT will return bi-weekly over the course of two months (four visits total) for follow-up. During months 3-5, PTs will call participants three times times to review the exercise plan. The last visit will be an at-home visit which will occur 6 months after the initial visit. Between Months 7-12, PTs will continue to a phone call follow-up once a month to review the exercise routine. Older Adults will receive an OEP manual and cuff weights to be used with the strength training. They will also have access to the OEP app which allows the PT to prescribe exercises and record the participant's exercise goal.
Receives: Behavioral: Otago Exercise Programme+ (OEP+)
Otago Exercise Programme Group (OEP)Placebo comparatorPhysiotherapists receive OEP Training and a 2 hour workshop on just the counselling protocol. Each PT will deliver exercise program to 8 older adults. PTs will help older adults to set-up the Fitbit. For the first two months, PTs will provide bi-weekly home visits. During months 3-5, PTs will call participants three times times to review the exercise plan. The last visit will be an at-home visit which will occur 6 months after the initial visit. Older Adults will receive an OEP manual and cuff weights to be used with the strength training. They will also receive a Fitbit. Between Months 7-12, older adults will receive follow-up phone calls from the research staff.
Receives: Behavioral: Otago Exercise Programme (OEP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physiotherapist-level outcome - Brief Action Planning (BAP) Scores

    This measure includes 33 items from three domains: 1) BAP content, 2) warmth and tone, and 3) overall interaction quality (total score: 0-35, higher score = better). The scores will be derived from the physiotherapists' sessions with the first, middle (Participant 3 or 4 out of 8) and last older adult participant. The recording from these treatment sessions will be coded and analysed by one of four researchers. The average of BAP scores of the middle and last participants for each PT will be used in the analysis .

    Measured: During the 12-month intervention

  2. Older Adult-Level Outcome - rate of adherence to the Otago Exercise Program (OEP)

    The number of exercise completed out of the total number of exercise prescribed during the intervention period

    Measured: During the 12-month intervention

Secondary outcomes (22)
  1. Older Adult-Level Outcome - Number of Falls

    Number of falls reported by the older adult participants. We define falls as "an event which results in a person coming to rest inadvertently on the ground or floor or other lower level".

    Measured: During the 12-month intervention

  2. Older Adult-Level Outcome - Number of Falls

    Number of falls during the reported. We define falls as "an event which results in a person coming to rest inadvertently on the ground or floor or other lower level".

    Measured: During the 12 months after the intervention (i.e., 13-24 months)

  3. Older Adult-Level Outcome - Physiological Profile Assessment© (PPA)

    PPA assesses risk of falls. Based on the performance of five domains (postural sway, hand reaction time, quadriceps strength, proprioception, and edge contrast sensitivity), a fall risk score will be computed for each participant. The PPA has a 75% predictive accuracy for falls in older people. A PPA z-score of 0-1 indicates mild risk, >1-2 indicates moderate risk, >2-3 indicates high risk, and >3 and above indicates marked risk.

    Measured: Baseline

  4. Older Adult-Level Outcome - Physiological Profile Assessment© (PPA)

    PPA assesses risk of falls. Based on the performance of five domains (postural sway, hand reaction time, quadriceps strength, proprioception, and edge contrast sensitivity), a fall risk score will be computed for each participant. The PPA has a 75% predictive accuracy for falls in older people. A PPA z-score of 0-1 indicates mild risk, >1-2 indicates moderate risk, >2-3 indicates high risk, and >3 and above indicates marked risk.

    Measured: 6 months

  5. Older Adult-Level Outcome - Physiological Profile Assessment© (PPA)

    PPA assesses risk of falls. Based on the performance of five domains (postural sway, hand reaction time, quadriceps strength, proprioception, and edge contrast sensitivity), a fall risk score will be computed for each participant. The PPA has a 75% predictive accuracy for falls in older people. A PPA z-score of 0-1 indicates mild risk, >1-2 indicates moderate risk, >2-3 indicates high risk, and >3 and above indicates marked risk.

    Measured: 12 months

  6. Older Adult-Level Outcome - Physiological Profile Assessment© (PPA)

    PPA assesses risk of falls. Based on the performance of five domains (postural sway, hand reaction time, quadriceps strength, proprioception, and edge contrast sensitivity), a fall risk score will be computed for each participant. The PPA has a 75% predictive accuracy for falls in older people. A PPA z-score of 0-1 indicates mild risk, >1-2 indicates moderate risk, >2-3 indicates high risk, and >3 and above indicates marked risk.

    Measured: 18 months

  7. Older Adult-Level Outcome - Physiological Profile Assessment© (PPA)

    PPA assesses risk of falls. Based on the performance of five domains (postural sway, hand reaction time, quadriceps strength, proprioception, and edge contrast sensitivity), a fall risk score will be computed for each participant. The PPA has a 75% predictive accuracy for falls in older people. A PPA z-score of 0-1 indicates mild risk, >1-2 indicates moderate risk, >2-3 indicates high risk, and >3 and above indicates marked risk.

    Measured: 24 months

  8. Older Adult-Level Outcome - Average Daily Step Count

    Measured by averaging the daily step counts, recorded by a Fitbit worn at the ankle (the non-dominant side), over seven days.

    Measured: Baseline

  9. Older Adult-Level Outcome - Average Daily Step Count

    Measured by averaging the daily step counts, recorded by a Fitbit worn at the ankle (the non-dominant side), over seven days.

    Measured: 6 months

  10. Older Adult-Level Outcome - Average Daily Step Count

    Measured by averaging the daily step counts, recorded by a Fitbit worn at the ankle (the non-dominant side), over seven days.

    Measured: 12 months

  11. Older Adult-Level Outcome - Average Daily Step Count

    Measured by averaging the daily step counts, recorded by a Fitbit worn at the ankle (the non-dominant side), over seven days.

    Measured: 18 months

  12. Older Adult-Level Outcome - Average Daily Step Count

    Measured by averaging the daily step counts, recorded by a Fitbit worn at the ankle (the non-dominant side), over seven days.

    Measured: 24 months

  13. Older Adult-Level Outcome - EuroQol-5D-5 Level version (EQ-5D-5L)

    EQ-5D-5L is a generic preference-based utility measure composed of 5 domains of health (mobility, self-care, usual activities, pain, and anxiety/depression). Each domain contains 5 levels, with a '1' indicating no problem and a '5' indicating major problem. The 5 dimensions (i.e., the health state profile) will be converted into a weighted health state utility values between '0' and '1', where '1' represents "perfect health" and '0' represents a health state equivalent to death. Values less than '0' indicate a health state worse than death. These health state utility values will provide weightings for QALYs. We will employ Canadian conversion tariffs for transforming health state profiles into utility scores.

    Measured: Baseline

  14. Older Adult-Level Outcome - EuroQol-5D-5 Level version (EQ-5D-5L)

    EQ-5D-5L is a generic preference-based utility measure composed of 5 domains of health (mobility, self-care, usual activities, pain, and anxiety/depression). Each domain contains 5 levels, with a '1' indicating no problem and a '5' indicating major problem. The 5 dimensions (i.e., the health state profile) will be converted into a weighted health state utility values between '0' and '1', where '1' represents "perfect health" and '0' represents a health state equivalent to death. Values less than '0' indicate a health state worse than death. These health state utility values will provide weightings for QALYs. We will employ Canadian conversion tariffs for transforming health state profiles into utility scores.

    Measured: 6 months

  15. Older Adult-Level Outcome - EuroQol-5D-5 Level version (EQ-5D-5L)

    EQ-5D-5L is a generic preference-based utility measure composed of 5 domains of health (mobility, self-care, usual activities, pain, and anxiety/depression). Each domain contains 5 levels, with a '1' indicating no problem and a '5' indicating major problem. The 5 dimensions (i.e., the health state profile) will be converted into a weighted health state utility values between '0' and '1', where '1' represents "perfect health" and '0' represents a health state equivalent to death. Values less than '0' indicate a health state worse than death. These health state utility values will provide weightings for QALYs. We will employ Canadian conversion tariffs for transforming health state profiles into utility scores.

    Measured: 12 months

  16. Older Adult-Level Outcome - EuroQol-5D-5 Level version (EQ-5D-5L)

    EQ-5D-5L is a generic preference-based utility measure composed of 5 domains of health (mobility, self-care, usual activities, pain, and anxiety/depression). Each domain contains 5 levels, with a '1' indicating no problem and a '5' indicating major problem. The 5 dimensions (i.e., the health state profile) will be converted into a weighted health state utility values between '0' and '1', where '1' represents "perfect health" and '0' represents a health state equivalent to death. Values less than '0' indicate a health state worse than death. These health state utility values will provide weightings for QALYs. We will employ Canadian conversion tariffs for transforming health state profiles into utility scores.

    Measured: 18 months

  17. Older Adult-Level Outcome - EuroQol-5D-5 Level version (EQ-5D-5L)

    EQ-5D-5L is a generic preference-based utility measure composed of 5 domains of health (mobility, self-care, usual activities, pain, and anxiety/depression). Each domain contains 5 levels, with a '1' indicating no problem and a '5' indicating major problem. The 5 dimensions (i.e., the health state profile) will be converted into a weighted health state utility values between '0' and '1', where '1' represents "perfect health" and '0' represents a health state equivalent to death. Values less than '0' indicate a health state worse than death. These health state utility values will provide weightings for QALYs. We will employ Canadian conversion tariffs for transforming health state profiles into utility scores.

    Measured: 24 months

  18. Older Adult-Level Outcome - Health Resource Utilization Questionnaire (HRU)

    The HRU asks for specific details regarding health professional visits, admissions to hospital, laboratory tests, use of medications, purchase of adaptive aids, and the productivity loss incurred by the older adults and their caregivers due to the person's poor health

    Measured: Baseline

  19. Older Adult-Level Outcome - Health Resource Utilization Questionnaire (HRU)

    The HRU asks for specific details regarding health professional visits, admissions to hospital, laboratory tests, use of medications, purchase of adaptive aids, and the productivity loss incurred by the older adults and their caregivers due to the person's poor health

    Measured: 3 months

  20. Older Adult-Level Outcome - Health Resource Utilization Questionnaire (HRU)

    The HRU asks for specific details regarding health professional visits, admissions to hospital, laboratory tests, use of medications, purchase of adaptive aids, and the productivity loss incurred by the older adults and their caregivers due to the person's poor health

    Measured: 6 months

  21. Older Adult-Level Outcome - Health Resource Utilization Questionnaire (HRU)

    The HRU asks for specific details regarding health professional visits, admissions to hospital, laboratory tests, use of medications, purchase of adaptive aids, and the productivity loss incurred by the older adults and their caregivers due to the person's poor health

    Measured: 9 months

  22. Older Adult-Level Outcome - Health Resource Utilization Questionnaire (HRU)

    The HRU asks for specific details regarding health professional visits, admissions to hospital, laboratory tests, use of medications, purchase of adaptive aids, and the productivity loss incurred by the older adults and their caregivers due to the person's poor health

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2021
  2. Study start1 Sep 2021
  3. Primary completion1 May 2025
  4. Study completion1 Jun 2026 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04851405
Sponsor's protocol ID
H19-01760
Status last verified
Jan 2026
First submitted
9 Apr 2021
Last updated
29 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Otago Exercise Programme+ (OEP+) and Otago Exercise Programme (OEP) in people with Old Age; Debility and Fall, run by University of British Columbia at 1 site in Canada.

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 14 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. 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 Canada. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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?

Physiotherapist-level outcome - Brief Action Planning (BAP) Scores (time frame: During the 12-month intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 Jan 2026.

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