Falls PreventionWalk On! NCOANCT07368907
Walk On! National Council on Aging Innovation Lab
A study testing Walk On! Program in people with Falls Prevention, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This is a multi-site, one-arm type-2 hybrid-effectiveness implementation trial. The goal of this clinical trial is to learn if the Walk On! program helps prevent falls in older adults who have trouble moving around or feel socially isolated. Researchers want to know: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Falls Prevention
- What is being tested?
- Walk On! Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2026to May 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Program Older Adult Participants: Inclusion Criteria:
- Age greater than or equal to 60 years
- Able to provide own transportation to the program each week
- No planned extended travel or time away during the 12 week program period
- English speaking with intact verbal and written communication skills
- Free of current fracture
- Able to ambulate independently, with or without an assistive device (i.e., cane or walker)
Program Participants: Exclusion Criteria:
- Serious or unstable medical or psychiatric condition that would prevent participation in research study
- Lack of decision-making capacity
- Participated in an evidence-based falls prevention program within the past 12 months
Community-Based Organizations (CBOs): Inclusion Criteria:
- Age greater than or equal to 18 years
- English speaking
Community-Based Organizations (CBOs): Exclusion Criteria:
- Not interested in offering a Walk On! program
- Unwilling and/or unable to participate in implementation activities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27101
Jaime M Hughes, MSW, MPH, PhD
About this study
This is a multi-site, one-arm type-2 hybrid-effectiveness implementation trial. The goal of this clinical trial is to learn if the Walk On! program helps prevent falls in older adults who have trouble moving around or feel socially isolated. Researchers want to know:
- What are the best ways for organizations to offer the Walk On! program and keep it running for older adults in their community?
- Does Walk On! help prevent falls in older adults?
Read more
Older Adult Participants will:
- Join group walking sessions led by a trained facilitator
- Meet twice a week for 12 weeks (24 sessions)
- Take part in simple tests before and after the program to see if there are any changes in older adults' function, confidence in not falling, or loneliness.
Read the detailed description
Despite the clear benefits of walking for individuals at risk of mobility disability, no National Council on Aging (NCOA)-approved evidence-based health programs emphasize walking in a supervised setting, particularly over longer distances. While some programs offer chair exercise, balance, and yoga/tai chi, these do not focus on structured, progressive walking for older adults with limited mobility. Additionally, many older adults living in rural areas have described living in a "health desert" with limited access to evidence-informed health promotion programs.
Walk On! is designed to provide community-based walking for older adults who are physically, socially and/or geographically isolated. This includes a focus on older adults with existing functional limitations and/or mobility challenges that may otherwise limit one's participation in community-based programs and/or individuals who live in rural areas without easy access to safe walking spaces. An underlying goal of this project is to expand access to Walk On! by starting programs in new spaces and places across diverse service sectors.
In brief, Walk On! is a facilitator-led, group-based program consisting of 24 sessions (twice weekly for 60 minutes over a 12 week period) focused on improving walking endurance, strength, and balance for older adults, including those with mobility limitations. Walk On! program facilitators will receive comprehensive implementation support and training to guide their organization in successfully starting and sustaining a program of their own.
Objectives: The long-term goal is to support unique community-based organizations in adopting and sustaining Walk On!. To support this goal this project will evaluate the following objectives:
Objective 1: Evaluate the effectiveness of comprehensive implementation support on community-based organizations adoption and sustainment of Walk On!.
Objective 2: Evaluate the impact of Walk On! on older adults' physical function, falls efficacy, and self-reported loneliness.
- Conditions
- Falls Prevention
- Being tested
- Walk On! Program
- Keywords
- Mobility Limitation, Implementation Science, Community-based
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk On! ProgramBehavioural
24 sessions (twice weekly for 60 minutes over 12 weeks) with a focus on improving walking endurance, strength, and balance in older adults, including those with mobility limitations. All intervention activities will take place in person within a community setting. The intervention will be delivered by trained facilitators based at community-based organizations. All facilitators will receive comprehensive training and implementation support as part of this study.
| Study group | Role | What they receive |
|---|---|---|
| Walk On! Program | Experimental | This study uses a single-group model in which all participating Community-Based Organizations (CBOs) receive the same implementation support for Walk On! intervention adoption and delivery. All older adult participants enrolled will receive the intervention. All activities will be unblinded. Intervention participants will be older adults, including those with mobility limitations, recruited from the local community. All intervention activities will take place in person within a community setting. The intervention will focus on improving walking endurance, strength, and balance. The intervention will be delivered by trained facilitators based at CBOs. All facilitators will receive comprehensive training and implementation support as part of this study. Receives: Behavioral: Walk On! Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption of Program
Number of community-based organizations that deliver of one full 12-week round of Walk On! to a minimum of 8 participants who have not previously participated in the program. Data Source: community-based organization's site attendance records.
Measured: Week 12
Fall Incidence
Number of falls in past 12 weeks (3 months), including number of injurious falls.
Data Source(s): Self-report, pre- and post-program assessment surveys. Number of Survey Items: 2. Total Score range: open-ended, 0 to no upper limit (higher score indicates more falls).
Measured: baseline
Fall Incidence
Number of falls in past 12 weeks (3 months), including number of injurious falls.
Data Source(s): Self-report, pre- and post-program assessment surveys. Number of Survey Items: 2. Total Score range: open-ended, 0 to no upper limit (higher score indicates more falls).
Measured: week 12
Fall self-efficacy
Confidence in performing daily activities without falling; fear of falling Data Source(s): Self-report, pre- and post-program assessments (Confidence in performing daily activities without falling; fear of falling) Number of Survey Items: 11 Total Score range: 11 to 44 (higher score indicates more confidence in performing daily activities without falling; less fear of falling)
Measured: baseline
Fall self-efficacy
Confidence in performing daily activities without falling; fear of falling. Data Source(s): Self-report, pre- and post-program assessments (Confidence in performing daily activities without falling; fear of falling).
Number of Survey Items: 11. Total Score range: 11 to 44 (higher score indicates more confidence in performing daily activities without falling; less fear of falling).
Measured: week 12
Secondary outcomes (2)
Loneliness
Frequency of feelings of isolation and loneliness (never to always). Data Source(s): Self-report, pre- and post-program assessment surveys. Number of Survey items: 2. Total Score Range: 0 to 8 (higher score indicates higher rating of feelings of loneliness and isolation.
Measured: baseline, week 12
Mobility
Definition: Distance walked. Data Source(s): 6-Minute Walk Test, pre- and post-program assessments. Total score range: 0 to no upper limit (higher score indicates greater distance walked, greater mobility) .
Measured: baseline, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start6 Apr 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Falls PreventionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study uses a single-group interventional model in which all participating Community-Based Organizations (CBOs) receive the same implementation support to promote program adoption. All older adult participants enrolled will receive the intervention. All activities will be unblinded. All intervention activities will take place in person within a community setting. Intervention participants will be older adults, including those with mobility limitations, recruited from the local community. The intervention will focus on improving walking endurance, strength, and balance. The intervention will be delivered by trained facilitators based at CBOs. All facilitators will receive comprehensive training and implementation support as part of this study.
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Council on Aging (NCOA)
- Responsible party
- Sponsor
- Investigators
- Jaime M Hughes, MSW, MPH, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368907
- Sponsor's protocol ID
- IRB00138002
- Other IDs
- 90ACIL0001
- Acronym
- Walk On! NCOA
- Status last verified
- Dec 2025
- First submitted
- 20 Jan 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walk On! National Council on Aging Innovation Lab
- ClinicalTrials.gov ID
- NCT07368907
- Acronym / sponsor ID
- Walk On! NCOA / IRB00138002
- Conditions
- Falls Prevention
- Keywords
- Mobility Limitation, Implementation Science, Community-based
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Council on Aging (NCOA)
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Jan 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.
This is a multi-site, one-arm type-2 hybrid-effectiveness implementation trial. The goal of this clinical trial is to learn if the Walk On! program helps prevent falls in older adults who have trouble moving around or feel socially isolated. Researchers want to know:
- What are the best ways for organizations to offer the Walk On! program and keep it running for older adults in their community?
- Does Walk On! help prevent falls in older adults?
Older Adult Participants will:
- Join group walking sessions led by a trained facilitator
- Meet twice a week for 12 weeks (24 sessions)
- Take part in simple tests before and after the program to see if there are any changes in older adults' function, confidence in not falling, or loneliness.
Detailed description
Despite the clear benefits of walking for individuals at risk of mobility disability, no National Council on Aging (NCOA)-approved evidence-based health programs emphasize walking in a supervised setting, particularly over longer distances. While some programs offer chair exercise, balance, and yoga/tai chi, these do not focus on structured, progressive walking for older adults with limited mobility. Additionally, many older adults living in rural areas have described living in a "health desert" with limited access to evidence-informed health promotion programs.
Walk On! is designed to provide community-based walking for older adults who are physically, socially and/or geographically isolated. This includes a focus on older adults with existing functional limitations and/or mobility challenges that may otherwise limit one's participation in community-based programs and/or individuals who live in rural areas without easy access to safe walking spaces. An underlying goal of this project is to expand access to Walk On! by starting programs in new spaces and places across diverse service sectors.
In brief, Walk On! is a facilitator-led, group-based program consisting of 24 sessions (twice weekly for 60 minutes over a 12 week period) focused on improving walking endurance, strength, and balance for older adults, including those with mobility limitations. Walk On! program facilitators will receive comprehensive implementation support and training to guide their organization in successfully starting and sustaining a program of their own.
Objectives: The long-term goal is to support unique community-based organizations in adopting and sustaining Walk On!. To support this goal this project will evaluate the following objectives:
Objective 1: Evaluate the effectiveness of comprehensive implementation support on community-based organizations adoption and sustainment of Walk On!.
Objective 2: Evaluate the impact of Walk On! on older adults' physical function, falls efficacy, and self-reported loneliness.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study uses a single-group interventional model in which all participating Community-Based Organizations (CBOs) receive the same implementation support to promote program adoption. All older adult participants enrolled will receive the intervention. All activities will be unblinded. All intervention activities will take place in person within a community setting. Intervention participants will be older adults, including those with mobility limitations, recruited from the local community. The intervention will focus on improving walking endurance, strength, and balance. The intervention will be delivered by trained facilitators based at CBOs. All facilitators will receive comprehensive training and implementation support as part of this study.
| Arm | Type | Receives |
|---|---|---|
| Walk On! Program | Experimental | Behavioral: Walk On! ProgramThis study uses a single-group model in which all participating Community-Based Organizations (CBOs) receive the same implementation support for Walk On! intervention adoption and delivery. All older adult participants enrolled will receive the intervention. All activities will be unblinded. Intervention participants will be older adults, including those with mobility limitations, recruited from the local community. All intervention activities will take place in person within a community setting. The intervention will focus on improving walking endurance, strength, and balance. The intervention will be delivered by trained facilitators based at CBOs. All facilitators will receive comprehensive training and implementation support as part of this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Walk On! Program24 sessions (twice weekly for 60 minutes over 12 weeks) with a focus on improving walking endurance, strength, and balance in older adults, including those with mobility limitations. All intervention activities will take place in person within a community setting. The intervention will be delivered by trained facilitators based at community-based organizations. All facilitators will receive comprehensive training and implementation support as part of this study. | Behavioural | Walk On! Program |
Primary outcome
Adoption of Program
Time frame: Week 12
Number of community-based organizations that deliver of one full 12-week round of Walk On! to a minimum of 8 participants who have not previously participated in the program. Data Source: community-based organization's site attendance records.
Fall Incidence
Time frame: baseline
Number of falls in past 12 weeks (3 months), including number of injurious falls. Data Source(s): Self-report, pre- and post-program assessment surveys. Number of Survey Items: 2. Total Score range: open-ended, 0 to no upper limit (higher score indicates more falls).
Fall Incidence
Time frame: week 12
Number of falls in past 12 weeks (3 months), including number of injurious falls. Data Source(s): Self-report, pre- and post-program assessment surveys. Number of Survey Items: 2. Total Score range: open-ended, 0 to no upper limit (higher score indicates more falls).
Fall self-efficacy
Time frame: baseline
Confidence in performing daily activities without falling; fear of falling Data Source(s): Self-report, pre- and post-program assessments (Confidence in performing daily activities without falling; fear of falling) Number of Survey Items: 11 Total Score range: 11 to 44 (higher score indicates more confidence in performing daily activities without falling; less fear of falling)
Fall self-efficacy
Time frame: week 12
Confidence in performing daily activities without falling; fear of falling. Data Source(s): Self-report, pre- and post-program assessments (Confidence in performing daily activities without falling; fear of falling). Number of Survey Items: 11. Total Score range: 11 to 44 (higher score indicates more confidence in performing daily activities without falling; less fear of falling).
2 secondary outcomes
Loneliness
Time frame: baseline, week 12
Mobility
Time frame: baseline, week 12
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 29 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Jaime M Hughes, MSW, MPH, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walk On! Program in people with Falls Prevention, run by Wake Forest University Health Sciences 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?
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 29 Apr 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 Jaime M Hughes, MSW, MPH, PhD (336-716-0835, jaime.hughes@wfusm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adoption of Program (time frame: Week 12). The study lists 5 primary outcomes in all. 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 29 Apr 2026.