- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07433153
Comparison of Smartphone and Community-Based Delivery of the Otago Exercise Program for Fall Risk in Older Adults
Effectiveness of Smartphone-Based Versus Community-Based Otago Exercise Programs for Fall Risk Reduction in Community-Dwelling Older Adults: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vipul Lugade, PhD
- Phone Number: 16077774700
- Email: vlugade@binghamton.edu
Study Contact Backup
- Name: Patima Silsupadol, PT, PhD
- Email: patimas@binghamton.edu
Study Locations
-
-
New York
-
Binghamton, New York, United States, 13902
- Recruiting
- Binghamton University
-
Contact:
- Vipul Lugade, PhD
- Phone Number: 6077774700
- Email: vlugade@binghamton.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Smartphone In-home Delivery
In-home 8-week OTAGO program
|
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:
|
|
Active Comparator: Group In-Person Delivery
In-Person 8-week Group OTAGO Program
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait Velocity
Time Frame: Baseline (Day 0) and 1 week post-training (9 weeks later)
|
Self-selected walking speed (m/s) over level surface
|
Baseline (Day 0) and 1 week post-training (9 weeks later)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Injurious Falls
Time Frame: Up to 1-year post intervention
|
Self-reported falls that lead to injury requiring clinical evaluation
|
Up to 1-year post intervention
|
|
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
|
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)
|
Simple reaction time (units: msec)
|
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)
|
Maximum isometric knee extensor force (kg)
|
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)
|
Melbourne Contrast Sensitivity (db), on a scale of 0-24
|
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)
|
Degrees offset in foot positioning
|
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)
|
Number of chair rises in 30-seconds
|
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)
|
Timed up and go test.
Rise from a chair, walk 3-meters, turn, and return walk, and sit back down at self-selected speed
|
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)
|
Total time to stand in side-to-side, semi-tandem, tandem, one-leg stance.
|
Baseline (Day 0) and 1 week post-training (9 weeks later)
|
|
Smartphone-based assessments
Time Frame: Weekly during 8-week training program
|
Self-evaluated walking speed as performed by participants at home
|
Weekly during 8-week training program
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline (Day 0) and 1 week post-training (9 weeks later)
|
|
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.
|
Baseline (Day 0) and 1 week post-training (9 weeks later)
|
|
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.
|
At study completion, or on average 1 week post-training
|
|
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.
|
Baseline (Day 0) and 1 week post-training (9 weeks later)
|
|
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.
|
Baseline (Day 0) and 1 week post-training (9 weeks later)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00006790
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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