NCT07433153

Brief Summary

The long-term goal of this project is to effectively bridge the research-clinic-community gap and to foster partnerships that support the implementation, utilization, and advocacy of evidence-based fall prevention programs in the older adult community. The Otago Exercise Program (OEP) is an evidence-based fall prevention program that has been shown to reduce falls and fall-related injuries among older adults. Traditionally, OEP is delivered in the home by a physical therapist and focuses on muscle strengthening and balance training. Despite its proven effectiveness, adherence and compliance rates have been low. The personnel and resource demands of program delivery, along with challenges in monitoring participant adherence, represent significant barriers to broader implementation. Alternative delivery systems using remote and community-based platforms may help address these limitations. Specific Aim 1: To compare the effectiveness of two delivery modes of the Otago Exercise Program: a remotely delivered, home-based smartphone program and an in-person, community-based program. Specific Aim 2: To examine the feasibility, acceptability, and usability of the Otago Exercise Program delivered through both smartphone-based and in-person formats.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

February 15, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

February 16, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

February 15, 2026

Last Update Submit

February 24, 2026

Conditions

Keywords

OtagoFallsSmartphoneGroup ExerciseBalanceStepping

Outcome Measures

Primary Outcomes (1)

  • Gait Velocity

    Self-selected walking speed (m/s) over level surface

    Baseline (Day 0) and 1 week post-training (9 weeks later)

Secondary Outcomes (10)

  • Injurious Falls

    Up to 1-year post intervention

  • PPA-Short Form: Postural Sway

    Baseline (Day 0) and 1 week post-training (9 weeks later)

  • PPA-Short Form: Finger Reaction Time

    Baseline (Day 0) and 1 week post-training (9 weeks later)

  • PPA-Short Form: Knee Extensor Strength

    Baseline (Day 0) and 1 week post-training (9 weeks later)

  • PPA-Short Form: Visual Contrast Sensitivity

    Baseline (Day 0) and 1 week post-training (9 weeks later)

  • +5 more secondary outcomes

Other Outcomes (5)

  • Four square step test

    Baseline (Day 0) and 1 week post-training (9 weeks later)

  • Frailty

    Baseline (Day 0) and 1 week post-training (9 weeks later)

  • Self-reported Assessment: Enjoyment

    At study completion, or on average 1 week post-training

  • +2 more other outcomes

Study Arms (2)

Smartphone In-home Delivery

EXPERIMENTAL

In-home 8-week OTAGO program

Behavioral: Smartphone-Based Intervention

Group In-Person Delivery

ACTIVE COMPARATOR

In-Person 8-week Group OTAGO Program

Behavioral: Group-Based Intervention

Interventions

Participants in the smartphone-based group will receive Otago Exercise Program instructions delivered through Improve, an investigator-developed application. This application, installed on each participant's iOS or Android smartphone, will allow participants to track their exercises and review workout instructions. Participants in the smartphone-based group will be contacted weekly by phone to ensure safety and adherence and to assist with troubleshooting any technology-related issues. All participants will be instructed to maintain their usual activity patterns and to refrain from initiating any new structured physical activity programs during the 8-week study period. Participants will be directed by Doctor of Physical Therapy students under the supervision of a licensed Physical Therapist, with weekly phone check-ins.

Also known as: Otago
Smartphone In-home Delivery

Participants in the in-person, community-based group will complete the individualized Otago Exercise Program in a group setting at the Johnson City Senior Center, under the guidance of Doctor of Physical Therapy students (4) and supervision of licensed Physical Therapists.

Also known as: Otago
Group In-Person Delivery

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community-dwelling older adults 55 years of age or older
  • Communicate in English
  • Able to ambulate at least 10 meters with or without an assistive device.
  • Cognitively intact based on scoring 18/22 or greater on the Montreal Cognitive Assessment (MoCA)-Blind during a phone screening process
  • Have access to an Android or iOS smartphone
  • Intermediate or high risk of falling, based on World Guidelines for Falls Prevention (Montero-Odasso et al, 2022)

You may not qualify if:

  • Lower limb amputation
  • Visual impairment uncorrectable with lenses
  • Uncontrolled hypertension, diabetes, neurological or musculoskeletal impairment
  • Persistent symptoms of dizziness or lightheadedness
  • Spine or lower-extremity surgery in the past 12 months
  • Self-reported pain of \>7 on a scale of 0-10

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Binghamton University

Binghamton, New York, 13902, United States

RECRUITING

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Vipul Lugade, PhD

CONTACT

Patima Silsupadol, PT, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 15, 2026

First Posted

February 25, 2026

Study Start

February 16, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations