Mobility LimitationLLWSNCT04026503
Live Long Walk Strong (LLWS) Rehabilitation Program: What Features Improve Mobility Skills
A study testing Live Long Walk Strong rehabilitation program in people with Mobility Limitation, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study was performed to evaluate the efficacy of the Live Long Walk Strong rehabilitation program in Veterans 50 years and older. This study will examine the features of the program that contribute to improved gait speed. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mobility Limitation
- What is being tested?
- Live Long Walk Strong rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2021to 7 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veteran
- Aged 50 and older
- Community dwelling
- Ability to speak and understand English
- Usual gait speed 0.5 m/s- 1.0 m/s Activity modifications and access to telehealth rehabilitation
Who cannot join
- Presence of a terminal disease
- A major medical problem, unstable chronic condition, or psychiatric disorder that interferes with safe and successful testing and training
- Myocardial infarction or major surgery in previous 3 months
- Planned major surgery
- Baseline short physical performance battery score less than 4
- Use of a walker
Show all 11Show fewer
- Modified mini mental status examination score less than or equal to 77
- Presence of a significant disease specific impairment such as:
- peripheral neurologic impairment
- orthopedic impairment
- visual impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
About this study
Official title: The Live Long Walk Strong Rehabilitation Program: What Features Improve Mobility Skills?
This study was performed to evaluate the efficacy of the Live Long Walk Strong rehabilitation program in Veterans 50 years and older. This study will examine the features of the program that contribute to improved gait speed.
Read the detailed description
This study was a 4 year phase II randomized clinical trial study design. This study will provide important information about the mechanisms that contribute to meaningful improvement in mobility, the benefits of a novel mode of physical therapy care, and the duration of treatment effect.
This study addresses Veterans with slow gait speed beginning in midlife. Slow walking speed is a major health concern for aging Veterans, that independent of disease status, predicts adverse health outcomes. Physical therapy (PT) care is the foundational treatment for slow gait speed, but no standard treatment approach exists. Clinically feasible modes of PT care that provide longer term improvements in gait speed are not established. The investigators developed Live Long Walk Strong , which is a clinically feasible program of PT care that builds upon research identifying novel modes of treatment with greater efficacy than standard care. The investigators have shown proof of concept among civilians and must confirm this among Veterans across a broader age range than was studied previously. Also, it is critical that the investigators define the attributes targeted by which LLWS induces gait speed improvements, not only after treatment ends but after 16 weeks of subsequent follow up. If successful, it will lead to LLWS refinements, establishing it as a rigorously tested model of PT care, that can be implemented across the VHA nationally.
- Conditions
- Mobility Limitation
- Being tested
- Live Long Walk Strong rehabilitation program
- Keywords
- Rehabilitation, Aging, Mobility Skills
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Long Walk Strong rehabilitation programOther
Live Long Walk Strong is a rehabilitation program that focuses on impairments known to contribute to mobility decline that are not considered standard of care in rehab and addresses behavioral change within the context of rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Live Long Walk Strong | Experimental | 8 week rehabilitation program Receives: Other: Live Long Walk Strong rehabilitation program |
| 8 week wait list control | Active comparator | 8 week wait list then followed by 8 weeks of the Live Long Walk Strong rehabilitation program Receives: Other: Live Long Walk Strong rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Speed
Walking (gait) speed is assessed as usual walking pace over a 4-meter course.
Measured: Randomization to 8 weeks (comparing intervention to wait list)
Secondary outcomes (3)
Lower Extremity Power
Lower extremity power measure will be assessed via the modified stair climb test.
Measured: Randomization to 8 weeks (comparing intervention to wait list groups)
Trunk Muscle Endurance
Trunk muscle endurance will be assessed via saunders table through time (seconds) held in a fixed position of trunk extension. Position is held up to 2 minutes and 30 seconds (150 seconds total). The data presented is normalized by body weight.
Measured: Randomization to 8 weeks (comparing intervention to wait list groups)
Gait Variability
Gait variability will be assessed via zeno gait mat measurement of step length, step width and other measures of gait quality captured via the pkmas software within the zeno gait mat. Gait variability is reported as the standard deviation of stance time variability (SD), the standard deviation of stance time standard deviation. This measures the variability of static position within the gait cycle.
Measured: Randomization to 8 weeks (comparing intervention to wait list groups)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start21 Jan 2021
- Primary completion30 Sep 2024
- Study completion7 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mobility LimitationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to 8 week Live Long Walk Strong (LLWS) rehabilitation or 8 week wait list control and then the LLWS rehabilitation program. The study is viewed as a randomized controlled trial comparing 8 weeks of LLWS rehabilitation to 8 weeks of wait list control. The long term follow up on the study, that occurs after the intervention is delivered to both groups, combines the cohort to examine the long term benefits of LLWS care.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jonathan F. Bean, MD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026503
- Sponsor's protocol ID
- E3095-R
- Acronym
- LLWS
- Status last verified
- Feb 2026
- First submitted
- 18 Jul 2019
- Last updated
- 20 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wingood M, Linsky AM, Harris R, Bamonti P, Moye J, Bean JF. Research Protocol Adaptations During the COVID-19 Pandemic: A Process Evaluation. J Aging Phys Act. 2023 Sep 12;32(1):62-68. doi: 10.1123/japa.2023-0052. Print 2024 Feb 1.
PubMed 37699586Harris R, Brach JS, Moye J, Ogawa E, Ward R, Halasz I, Bean J. The Live Long Walk Strong Rehabilitation Program Study: Design and Methods. Arch Rehabil Res Clin Transl. 2022 May 29;4(3):100205. doi: 10.1016/j.arrct.2022.100205. eCollection 2022 Sep.
PubMed 36123980Harris R, Ogawa EF, Ward RE, Fitzelle-Jones E, Travison T, Brach JS, Bean JF. Feasibility and Preliminary Efficacy of Virtual Rehabilitation for Middle and Older Aged Veterans With Mobility Limitations: A Pilot Study. Arch Rehabil Res Clin Transl. 2024 Feb 12;6(2):100325. doi: 10.1016/j.arrct.2024.100325. eCollection 2024 Jun.
PubMed 39006121Bamonti PM, Moye J, Harris R, Kallmi S, Kelly CA, Middleton A, Bean JF. Development of a Coaching Protocol to Enhance Self-efficacy Within Outpatient Physical Therapy. Arch Rehabil Res Clin Transl. 2022 Apr 21;4(2):100198. doi: 10.1016/j.arrct.2022.100198. eCollection 2022 Jun.
PubMed 35756988Ogawa EF, Harris R, Moye J, Bean JF, Kim B. Veterans' Motivation, Preference, and Feedback After Completing a Novel Physical Therapy Treatment. J Aging Phys Act. 2025 Jan 17;33(4):379-386. doi: 10.1123/japa.2023-0446. Print 2025 Aug 1.
PubMed 39826533
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Live Long Walk Strong Rehabilitation Program: What Features Improve Mobility Skills?
- ClinicalTrials.gov ID
- NCT04026503
- Acronym / sponsor ID
- LLWS / E3095-R
- Conditions
- Mobility Limitation
- Keywords
- Rehabilitation, Aging, Mobility Skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 7 Nov 2024 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Posted 20 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was performed to evaluate the efficacy of the Live Long Walk Strong rehabilitation program in Veterans 50 years and older. This study will examine the features of the program that contribute to improved gait speed.
Detailed description
This study was a 4 year phase II randomized clinical trial study design. This study will provide important information about the mechanisms that contribute to meaningful improvement in mobility, the benefits of a novel mode of physical therapy care, and the duration of treatment effect.
This study addresses Veterans with slow gait speed beginning in midlife. Slow walking speed is a major health concern for aging Veterans, that independent of disease status, predicts adverse health outcomes. Physical therapy (PT) care is the foundational treatment for slow gait speed, but no standard treatment approach exists. Clinically feasible modes of PT care that provide longer term improvements in gait speed are not established. The investigators developed Live Long Walk Strong , which is a clinically feasible program of PT care that builds upon research identifying novel modes of treatment with greater efficacy than standard care. The investigators have shown proof of concept among civilians and must confirm this among Veterans across a broader age range than was studied previously. Also, it is critical that the investigators define the attributes targeted by which LLWS induces gait speed improvements, not only after treatment ends but after 16 weeks of subsequent follow up. If successful, it will lead to LLWS refinements, establishing it as a rigorously tested model of PT care, that can be implemented across the VHA nationally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to 8 week Live Long Walk Strong (LLWS) rehabilitation or 8 week wait list control and then the LLWS rehabilitation program. The study is viewed as a randomized controlled trial comparing 8 weeks of LLWS rehabilitation to 8 weeks of wait list control. The long term follow up on the study, that occurs after the intervention is delivered to both groups, combines the cohort to examine the long term benefits of LLWS care.
| Arm | Type | Receives |
|---|---|---|
| Live Long Walk Strong | Experimental | Other: Live Long Walk Strong rehabilitation program8 week rehabilitation program |
| 8 week wait list control | Active comparator | Other: Live Long Walk Strong rehabilitation program8 week wait list then followed by 8 weeks of the Live Long Walk Strong rehabilitation program |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Veteran
- Aged 50 and older
- Community dwelling
- Ability to speak and understand English
- Usual gait speed 0.5 m/s- 1.0 m/s Activity modifications and access to telehealth rehabilitation
Key exclusion criteria (11 listed)
- Presence of a terminal disease
- A major medical problem, unstable chronic condition, or psychiatric disorder that interferes with safe and successful testing and training
- Myocardial infarction or major surgery in previous 3 months
- Planned major surgery
- Baseline short physical performance battery score less than 4
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 |
|---|---|---|
| Live Long Walk Strong rehabilitation programLive Long Walk Strong is a rehabilitation program that focuses on impairments known to contribute to mobility decline that are not considered standard of care in rehab and addresses behavioral change within the context of rehabilitation. | Other | 8 week wait list control, Live Long Walk Strong |
Primary outcome
Walking Speed
Time frame: Randomization to 8 weeks (comparing intervention to wait list)
Walking (gait) speed is assessed as usual walking pace over a 4-meter course.
3 secondary outcomes
Lower Extremity Power
Time frame: Randomization to 8 weeks (comparing intervention to wait list groups)
Trunk Muscle Endurance
Time frame: Randomization to 8 weeks (comparing intervention to wait list groups)
Gait Variability
Time frame: Randomization to 8 weeks (comparing intervention to wait list groups)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37699586Wingood M, Linsky AM, Harris R, Bamonti P, Moye J, Bean JF. Research Protocol Adaptations During the COVID-19 Pandemic: A Process Evaluation. J Aging Phys Act. 2023 Sep 12;32(1):62-68. doi: 10.1123/japa.2023-0052. Print 2024 Feb 1.
- Background: PubMed 36123980Harris R, Brach JS, Moye J, Ogawa E, Ward R, Halasz I, Bean J. The Live Long Walk Strong Rehabilitation Program Study: Design and Methods. Arch Rehabil Res Clin Transl. 2022 May 29;4(3):100205. doi: 10.1016/j.arrct.2022.100205. eCollection 2022 Sep.
- Background: PubMed 39006121Harris R, Ogawa EF, Ward RE, Fitzelle-Jones E, Travison T, Brach JS, Bean JF. Feasibility and Preliminary Efficacy of Virtual Rehabilitation for Middle and Older Aged Veterans With Mobility Limitations: A Pilot Study. Arch Rehabil Res Clin Transl. 2024 Feb 12;6(2):100325. doi: 10.1016/j.arrct.2024.100325. eCollection 2024 Jun.
- Background: PubMed 35756988Bamonti PM, Moye J, Harris R, Kallmi S, Kelly CA, Middleton A, Bean JF. Development of a Coaching Protocol to Enhance Self-efficacy Within Outpatient Physical Therapy. Arch Rehabil Res Clin Transl. 2022 Apr 21;4(2):100198. doi: 10.1016/j.arrct.2022.100198. eCollection 2022 Jun.
- Background: PubMed 39826533Ogawa EF, Harris R, Moye J, Bean JF, Kim B. Veterans' Motivation, Preference, and Feedback After Completing a Novel Physical Therapy Treatment. J Aging Phys Act. 2025 Jan 17;33(4):379-386. doi: 10.1123/japa.2023-0446. Print 2025 Aug 1.
- 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. This study is not recruiting at the moment.
Jonathan F. Bean, MD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live Long Walk Strong rehabilitation program in people with Mobility Limitation, run by VA Office of Research and Development 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 20 Feb 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?
Yes. Results are posted in the registry (first posted 20 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Speed (time frame: Randomization to 8 weeks (comparing intervention to wait list)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04026503, which also lists 5 linked publications.
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 20 Feb 2026.