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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Behavioral Smartphone-Based Intervention
  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 parti
• Behavioral Group-Based Intervention
  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.

Primary outcome measures

• Gait Velocity [Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)]

Secondary outcome measures (10)

• Injurious Falls [Time frame: Up to 1-year post intervention]
• PPA-Short Form: Postural Sway [Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)]
• PPA-Short Form: Finger Reaction Time [Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)]
• PPA-Short Form: Knee Extensor Strength [Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)]
• PPA-Short Form: Visual Contrast Sensitivity [Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)]
• PPA-Short Form: Proprioception [Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)]
• 30-second Chair Stand [Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)]
• TUG [Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)]
• Four-Stage Balance [Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)]
• Smartphone-based assessments [Time frame: Weekly during 8-week training program]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Binghamton University — Binghamton

Identifiers

NCT: NCT07433153 · STUDY00006790

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗