OTAGO Exercise Program and Motivational Interviewing

Health Behavior Change for Fall Prevention

The goal of this study is to see if OTAGO instructors, who have been trained in a special communication method called motivational interviewing, can help older adults start and stick with the OTAGO exercise program. The results will help guide future research on how behavior change techniques can support other fall prevention strategies.

Study Overview

• Status: Recruiting
• Conditions: Physical Activity; Engagement, Patient; Community-dwelling Older Adults; Fall Risk Factors
• Intervention / Treatment: Behavioral: OTAGO Exercise Program with motivational interviewing

Detailed Description

The objective of this study is to evaluate the feasibility and impact of OTAGO instructors who are trained in motivational interviewing communication approach to facilitate older adult's uptake of the OTAGO exercises. This study will create the basis for future trials that will explore the impact of behavior change interventions on other fall prevention strategies.

We propose a single-arm quasi-experimental trial with older adults with high fall risks. The study intervention consists of OTAGO visits by study staff (MI-trained OTAGO instructor) over 6 months to improve older adults' engagement in fall prevention behaviors with a focus on OTAGO exercises. Participants will be followed for additional 6 months for the total study duration of 12 months.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hiroko Kiyoshi-Teo, PhD, RN; Phone Number: 5034943858; Email: kiyoshi@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥60
• At high fall risk: At least one "Yes" to 1) had a fall in the past year; 2) answer "difficult" to the question "do you find it hard to stand without using your hands"; 3) worry about falling
• Able to converse audibly and coherently in English
• Ambulatory with or without assistive device use
• Self-report challenges navigating the environment outside of the home
• At least one "some or much difficulty" or "unable to do" to:Walking one block?; Stepping up onto a curb?; Getting out of a straight back chair? Climbing one flight of stairs? Getting out of the house

Exclusion Criteria:

• o Receiving ongoing physical therapy with a primary focus on improving balance and strength of lower extremities

  • Experiencing acute health issues such as fracture, pain, or infection that prohibits them from participating in exercises
  • Able to stand on one foot for more than 10 seconds without holding onto something
  • 6-item Callahan cognitive assessment over the phone: Patients with scores of 2 or less, positive for dementia criteria, will be excluded.
  • Patients participating in other studies that may impact fall-related behavior change.
  • Participants engaged in routine moderate or vigorous physical activities that require lower extremity balance and strength (e.g., >100 minutes/week for more than 3 months)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; OTAGO exercise home visits will be offered 7 times with 2 phone-based check-ins during the 6-month period. As part of OTAGO home visits, participants will receive OTAGO exercise instruction and MI. Each home visit will be approximately an hour.	Behavioral: OTAGO Exercise Program with motivational interviewing; OTAGO exercise home visits will be offered 7 times with 2 phone-based check-ins during the 6-month period. As part of OTAGO home visits, participants will receive OTAGO exercise instruction and MI. Each home visit will be approximately an hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OTAGO exercise adherence	Number of instructed OTAGO exercises completed in a week	Baseline, 6-months & 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
4-stage balance test	Participants are asked to hold four standing positions that get progressively harder to maintain.; Stand with your feet side-by-side; Place the instep of one foot so it is touching the big toe of the other foot.; Tandem stance Place one foot in front of the other, heel touching toes; Stand on one foot.	Baseline & 6-months
Sit-to-stand test	Participants are asked to stand from a seated position. We count the number of sit-stand-sit repetitions completed during 30 seconds	Baseline & 6-months
Falls Efficacy Scale Short International	Measures levels of concern about falls. 7-item, 4-point Likert-type scale; 28: highest concern	Baseline, 6-months, and 12-months

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Oregon Wellness Network

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: April 9, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Motivational interviewing; behavior change; OTAGO; OEP
• Other Study ID Numbers: 27787

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified study IPD may be shared upon request.
• IPD Sharing Time Frame: After the completion of all study data collection, analysis, and publication. IPD will be available for 5 years.
• IPD Sharing Access Criteria: Individuals interested in IPD must contact the PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No