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

NCT ID: NCT04851405

Last Updated: 2022-05-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2024-09-01

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.

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).

Conditions

Old Age; Debility; Fall

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Otago Exercise Programme+ Intervention Group (OEP+)

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.

Group Type: ACTIVE_COMPARATOR

Otago Exercise Programme+ (OEP+)

Intervention Type: 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 Group (OEP)

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.

Group Type: PLACEBO_COMPARATOR

Otago Exercise Programme (OEP)

Intervention Type: 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).

Interventions

Otago Exercise Programme+ (OEP+)

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.

Intervention Type: BEHAVIORAL

Otago Exercise Programme (OEP)

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• people not meeting the criteria above

• not willing to participate in the above criteria

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arthritis Research Centre of Canada

OTHER

Sponsor Role: collaborator

Vancouver General Hospital

OTHER

Sponsor Role: collaborator

Simon Fraser University

OTHER

Sponsor Role: collaborator

Vancouver Coastal Health Research Institute

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Linda Li

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Linda Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

Arthritis Research Canada

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Stephanie Therrien, BA

Role: CONTACT

stherrien@arthritisresearch.ca

604-207-4053

Johnathan Tam, BSc

Role: CONTACT

jtam@arthritisresearch.ca

604-207-4027

Facility Contacts

Stephanie Therrien, BA

Role: primary

stherrien@arthritisresearch.ca

604-207-4053

Johnathan Tam, BSc

Role: backup

jtam@arthritisresearch.ca

604-207-4027

Other Identifiers

H19-01760

Identifier Type: -

Identifier Source: org_study_id