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NCT Number: NCT07433153

Comparison of Smartphone and Community-Based Delivery of the Otago Exercise Program for Fall Risk in Older Adults

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.

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Key information

Conditions

Frail Elderly Fall Gait Disorders, Neurologic Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Binghamton University

Binghamton, New York, 13902, United States

Location status: Recruiting

Location contact

Vipul Lugade, PhD

CONTACT

[email protected]

6077774700

About this study

Thirty eligible participants will provide written informed consent prior to enrollment. In accordance with the World Guidelines for Falls Prevention, participants will be stratified into low-, intermediate-, and high-risk groups. Following the first visit assessment, older adults classified as intermediate or high risk will be randomly assigned to one of two intervention groups: (1) a remotely delivered, smartphone- based Otago Exercise Program, or (2) an in-person, community-based Otago Exercise Program.

Participants in both groups will receive individualized 60-minute training sessions, two times per week for eight weeks. Across the sixteen training sessions, participants will receive a progressive balance, mobility, and strengthening program following the structure of the Otago Exercise Program.

Prior to and immediately following the exercise program, participants are asked to complete several surveys and evaluations, including: demographics, STEADI-12, SF-36, Geriatric Depression Scale (GDS), Falls Efficacy Scale-International (FES-I), Four-Square Stepping Test, Timed Up and Go Test (TUG), Ten-meter Walk Test, Four-Stage Balance Test, 30-second chair stand, and the Physiological Profile Assessment (PPA). All outcome measures will be collected at baseline and at the end of the intervention, with testers blinded to participant group allocation, and trainers blinded to baseline outcomes. In addition, gait speed will be assessed weekly using smartphone-based measurements.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Smartphone-Based Intervention

Behavioral

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.

Other names: Otago

Group-Based Intervention

Behavioral

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.

Other names: Otago

Primary outcomes

  1. Gait Velocity

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

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

Secondary outcomes

  1. Injurious Falls

    Time frame: Up to 1-year post intervention

    Self-reported falls that lead to injury requiring clinical evaluation

  2. PPA-Short Form: Postural Sway

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

    Sway Area (units: mm^2) while standing quietly for 30 seconds

  3. PPA-Short Form: Finger Reaction Time

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

    Simple reaction time (units: msec)

  4. PPA-Short Form: Knee Extensor Strength

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

    Maximum isometric knee extensor force (kg)

  5. PPA-Short Form: Visual Contrast Sensitivity

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

    Melbourne Contrast Sensitivity (db), on a scale of 0-24

  6. PPA-Short Form: Proprioception

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

    Degrees offset in foot positioning

  7. 30-second Chair Stand

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

    Number of chair rises in 30-seconds

  8. TUG

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

    Timed up and go test. Rise from a chair, walk 3-meters, turn, and return walk, and sit back down at self-selected speed

  9. Four-Stage Balance

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

    Total time to stand in side-to-side, semi-tandem, tandem, one-leg stance.

  10. Smartphone-based assessments

    Time frame: Weekly during 8-week training program

    Self-evaluated walking speed as performed by participants at home

Other outcomes

  1. Four square step test

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

    Time to complete a clockwise and counterclockwise stepping into four quadrants

  2. Frailty

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

    Physical Frailty Phenotype, reported on a scale of 0-5. A higher score indicates increased frailty.

  3. Self-reported Assessment: Enjoyment

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

    Participant report of enjoyment, usability, and feasibility of the exercise program (1-5 scale), where higher scores indicate increased self-report.

  4. SF-36

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

    Short-form health survey to evaluate participant self-reported health quality of life.

  5. STEADI

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

    Self-report (0 to 14-point scale), where increased scores indicate increased fall risk.

Study contacts

Contact information is provided by the study sponsor or research team.

Patima Silsupadol, PT, PhD

CONTACT

[email protected]

Vipul Lugade, PhD

CONTACT

[email protected]

16077774700

Sponsors and collaborators

Lead sponsor

Binghamton University

Other

Registry information

Official study title

Effectiveness of Smartphone-Based Versus Community-Based Otago Exercise Programs for Fall Risk Reduction in Community-Dwelling Older Adults: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2026
Registry last updated
Feb 25, 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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