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

NCT04851405 | Active Not Recruiting

• 1 other identifier: H19-01760
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Old Age; Debility; Fall

Keywords

Exercise; Strength Training; Fitbit

Outcome Measures

Primary Outcomes (2)

• 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 .

  During the 12-month intervention

• 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

  During the 12-month intervention

Secondary Outcomes (22)

• Older Adult-Level Outcome - Number of Falls

  During the 12-month intervention

• Older Adult-Level Outcome - Number of Falls

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

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

  Baseline

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

  6 months

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

  12 months

Study Arms (2)

Otago Exercise Programme+ Intervention Group (OEP+)

ACTIVE COMPARATOR

Physiotherapists 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.

Behavioral: Otago Exercise Programme+ (OEP+)

Otago Exercise Programme Group (OEP)

PLACEBO COMPARATOR

Physiotherapists 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.

Behavioral: Otago Exercise Programme (OEP)

Interventions

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).

Otago Exercise Programme Group (OEP)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead
• Arthritis Research Centre of Canada: collaborator
• Vancouver General Hospital: collaborator
• Simon Fraser University: collaborator
• Vancouver Coastal Health Research Institute: collaborator

Study Sites (1)

Arthritis Research Canada

Vancouver, British Columbia, V5Y 3P2, Canada

Location

MeSH Terms

Conditions

Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Linda Li, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 20, 2021
• Study Start: September 1, 2021
• Primary Completion: May 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)