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Active, Not Recruiting

NCT Number: NCT04851405

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Old Age; Debility Behavior Fall Frailty Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arthritis Research Canada

Vancouver, British Columbia, V5Y 3P2, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Older Adults):

  • 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
  • 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

Exclusion criteria

(Older Adults):

  • people not meeting the criteria above

Inclusion criteria

(Physiotherapists):

  • 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

Exclusion criteria

(Physiotherapists):

  • not willing to participate in the above criteria

Treatment and study plan

Otago Exercise Programme+ (OEP+)

Behavioral

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)

Behavioral

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).

Primary outcomes

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

    Time frame: During the 12-month intervention

    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 .

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

    Time frame: During the 12-month intervention

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

Secondary outcomes

  1. Older Adult-Level Outcome - Number of Falls

    Time frame: During the 12-month intervention

    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".

  2. Older Adult-Level Outcome - Number of Falls

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

    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".

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

    Time frame: Baseline

    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.

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

    Time frame: 6 months

    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.

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

    Time frame: 12 months

    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.

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

    Time frame: 18 months

    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.

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

    Time frame: 24 months

    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.

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

    Time frame: Baseline

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

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

    Time frame: 6 months

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

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

    Time frame: 12 months

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

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

    Time frame: 18 months

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

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

    Time frame: 24 months

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

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

    Time frame: Baseline

    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.

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

    Time frame: 6 months

    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.

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

    Time frame: 12 months

    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.

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

    Time frame: 18 months

    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.

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

    Time frame: 24 months

    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.

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

    Time frame: Baseline

    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

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

    Time frame: 3 months

    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

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

    Time frame: 6 months

    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

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

    Time frame: 9 months

    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

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

    Time frame: 12 months

    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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Arthritis Research Centre of Canada
  • Simon Fraser University
  • Vancouver Coastal Health Research Institute
  • Vancouver General Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Apr 20, 2021
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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