Frail ElderlyNCT07433153
Comparison of Smartphone and Community-Based Delivery of the Otago Exercise Program for Fall Risk in Older Adults
A study testing Smartphone-Based Intervention and Group-Based Intervention in people with Frail Elderly and Fall, run by Binghamton University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Frail Elderly, Fall
- What is being tested?
- Smartphone-Based Intervention and Group-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Patima Silsupadol, PT, PhD contact
United States1 site, 1 recruiting
- Recruiting
Binghamton University
Binghamton, New York, 13902
Vipul Lugade, PhD, 6077774700, vlugade@binghamton.edu
About this study
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
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.
Read the 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.
- Conditions
- Frail Elderly, Fall
- Being tested
- Smartphone-Based Intervention, Group-Based Intervention
- Keywords
- Otago, Falls, Smartphone, Group Exercise, Balance, Stepping
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-Based InterventionBehavioural
Also called Otago
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.
Group-Based InterventionBehavioural
Also called Otago
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.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone In-home Delivery | Experimental | In-home 8-week OTAGO program Receives: Behavioral: Smartphone-Based Intervention |
| Group In-Person Delivery | Active comparator | In-Person 8-week Group OTAGO Program Receives: Behavioral: Group-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Velocity
Self-selected walking speed (m/s) over level surface
Measured: Baseline (Day 0) and 1 week post-training (9 weeks later)
Secondary outcomes (10)
Injurious Falls
Self-reported falls that lead to injury requiring clinical evaluation
Measured: Up to 1-year post intervention
PPA-Short Form: Postural Sway
Sway Area (units: mm^2) while standing quietly for 30 seconds
Measured: Baseline (Day 0) and 1 week post-training (9 weeks later)
PPA-Short Form: Finger Reaction Time
Simple reaction time (units: msec)
Measured: Baseline (Day 0) and 1 week post-training (9 weeks later)
PPA-Short Form: Knee Extensor Strength
Maximum isometric knee extensor force (kg)
Measured: Baseline (Day 0) and 1 week post-training (9 weeks later)
PPA-Short Form: Visual Contrast Sensitivity
Melbourne Contrast Sensitivity (db), on a scale of 0-24
Measured: Baseline (Day 0) and 1 week post-training (9 weeks later)
PPA-Short Form: Proprioception
Degrees offset in foot positioning
Measured: Baseline (Day 0) and 1 week post-training (9 weeks later)
30-second Chair Stand
Number of chair rises in 30-seconds
Measured: Baseline (Day 0) and 1 week post-training (9 weeks later)
TUG
Timed up and go test. Rise from a chair, walk 3-meters, turn, and return walk, and sit back down at self-selected speed
Measured: Baseline (Day 0) and 1 week post-training (9 weeks later)
Four-Stage Balance
Total time to stand in side-to-side, semi-tandem, tandem, one-leg stance.
Measured: Baseline (Day 0) and 1 week post-training (9 weeks later)
Smartphone-based assessments
Self-evaluated walking speed as performed by participants at home
Measured: Weekly during 8-week training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start16 Feb 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Binghamton University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vipul Lugade, Binghamton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433153
- Sponsor's protocol ID
- STUDY00006790
- Status last verified
- Aug 2026
- First submitted
- 15 Feb 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No identifying information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07433153
- Acronym / sponsor ID
- STUDY00006790
- Conditions
- Frail Elderly, Fall
- Keywords
- Otago, Falls, Smartphone, Group Exercise, Balance, Stepping
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Binghamton UniversityUniversity, hospital or other
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone In-home Delivery | Experimental | Behavioral: Smartphone-Based InterventionIn-home 8-week OTAGO program |
| Group In-Person Delivery | Active comparator | Behavioral: Group-Based InterventionIn-Person 8-week Group OTAGO Program |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone-Based InterventionAlso: OtagoParticipants 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. | Behavioural | Smartphone In-home Delivery |
| Group-Based InterventionAlso: OtagoParticipants 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. | Behavioural | Group In-Person Delivery |
Primary outcome
Gait Velocity
Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)
Self-selected walking speed (m/s) over level surface
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Undecided. No identifying information will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patima Silsupadol, PT, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-Based Intervention and Group-Based Intervention in people with Frail Elderly and Fall, run by Binghamton University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vipul Lugade, PhD (16077774700, vlugade@binghamton.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Velocity (time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.