An interventional study of Walk On! Program in Falls Prevention, sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Prevention
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:
Older Adult Participants will:
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.
317 studies on the registry are indexed under Mobility Limitation; 97 are open to participants now.
This study's planned enrollment of 192 is above the median of 46 across 265 interventional studies indexed under Mobility Limitation.
Browse Mobility Limitation studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Program Older Adult Participants: Inclusion Criteria:
Program Participants: Exclusion Criteria:
Community-Based Organizations (CBOs): Inclusion Criteria:
Community-Based Organizations (CBOs): Exclusion Criteria:
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.
Behavioral: Walk On! Program
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.
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.
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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).
Time frame: week 12
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.
Time frame: 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) .
Time frame: baseline, week 12
Sustainment of Program
Number of community-based organizations that deliver one or more additional full 12-week round(s) of Walk On! to a minimum of 8 participants. Data source is community-based organization's site attendance records.
Time frame: week 36
Plan to share: No
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Wake Forest University Health Sciences