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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Live Long Walk Strong | Experimental | 8 week rehabilitation program |
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| 8 week wait list control | Active Comparator | 8 week wait list then followed by 8 weeks of the Live Long Walk Strong rehabilitation program |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live Long Walk Strong rehabilitation program | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Walking Speed | Walking (gait) speed is assessed as usual walking pace over a 4-meter course. | Randomization to 8 weeks (comparing intervention to wait list) |
| Measure | Description | Time Frame |
|---|---|---|
| Lower Extremity Power | Lower extremity power measure will be assessed via the modified stair climb test. | Randomization to 8 weeks (comparing intervention to wait list groups) |
| Trunk Muscle Endurance |
| Measure | Description | Time Frame |
|---|---|---|
| Cognition - Delis-Kaplan Executive Function Systems (DKEFS) Verbal Fluency | A cognitive battery, including the DKEFS verbal fluency will be assessed pre and post intervention (within 2 weeks). Raw scores are used for each sub-test. The mean change in the raw score over the 8 weeks is reported.
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Inclusion Criteria:
Exclusion Criteria:
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
Modified mini mental status examination score less than or equal to 77
Presence of a significant disease specific impairment such as:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan F. Bean, MD | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts | 02130-4817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37699586 | Background | 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. | |
| 36123980 | Background | Harris 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. |
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Veterans within VA Boston Healthcare System 50 years and older Walking Speed between 0.5 m/s and 1.0 m/s Short Physical Performance Battery > 4/12
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| ID | Title | Description |
|---|---|---|
| FG000 | Live Long Walk Strong | 8 week rehabilitation program: 10 1-hour sessions over 8 weeks. Participants were followed after the completion of the intervention in this manner: Post 1 visit occurring within 2 weeks after the intervention ended Post 2 visit occurring 8 weeks after the intervention ended Post 3 occurring 16 weeks after the intervention ended |
| FG001 | 8 Week Wait List Control | 8 week wait list control; following the 8 weeks participants completed a repeat baseline visit. Participants were then given 8 weeks of the Live Long Walk Strong rehabilitation program (10 1-hour sessions). Participants were followed after the completion of the intervention in this manner: Post 1 visit occurring within 2 weeks after the intervention ended Post 2 visit occurring 8 weeks after the intervention ended Post 3 occurring 16 weeks after the intervention ended |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomize to 8 Weeks (LLWS PT or Wait) |
| |||||||||||||
| Wait List Control Receives LLWS PT |
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| Post 1 Both Groups Post LLWS PT |
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| Post 2 Both Groups 8 Weeks Post LLWS PT |
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| Post 3 Both Groups 16 Weeks Post LLWS PT |
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Some data lost to equipment failure and assessor error.
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| ID | Title | Description |
|---|---|---|
| BG000 | Live Long Walk Strong | Group randomized to 8 week rehabilitation program (10 1-hour sessions over 8 weeks) |
| BG001 | 8 Week Wait List Control | Group randomized to 8 week wait list then followed by 8 weeks of the Live Long Walk Strong rehabilitation program ( (10 1-hour sessions over 8 weeks) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at baseline |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Walking Speed | Walking (gait) speed is assessed as usual walking pace over a 4-meter course. | Differences due to study drop outs, COVID restricted study visits that resulted in remote assessment only, equipment failure, and assessor error. | Posted | Mean | Standard Deviation | m/s | Randomization to 8 weeks (comparing intervention to wait list) |
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From Enrollment to 16 weeks of follow-up after the intervention (24 weeks total)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Live Long Walk Strong | Group Randomized to LLWS treatment for 8 weeks | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal vital signs following exercise | Musculoskeletal and connective tissue disorders | Systematic Assessment | Abnormal Vital Signs |
Limitations: the study was impacted by the COVID 19 pandemic in recruitment and retention; Veteran cohort that may not be generalizable to all
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jonathan F. Bean | VHA | 857-364-2786 | jonathan.bean4@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 8, 2019 | Nov 18, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 8, 2019 | Nov 6, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 4, 2021 | Sep 10, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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Participants are randomized through block permuted generated lists performed by the study biostatistician.
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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.
| 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. | Randomization to 8 weeks (comparing intervention to wait list groups) |
| Randomization to 8 weeks (comparing intervention to wait list groups) |
| Cognition- DKEFS Trail Making Test | The DKEFS Trail Making Test used conditions 2 and 4. Time to complete was used to calculate the mean change over the 8-weeks. Mean change in time to complete each condition are reported. | Randomization to 8 weeks (comparing intervention to wait list) |
| Adherence | Adherence will be assessed by drop out status during the intervention period for each group respectively. This will be scored as a yes or no variable. | Intervention Period (8-weeks) |
| Compliance | Compliance with be assessed by the number of intervention sessions attended (out of 10). | Intervention Period (8-weeks) |
| 39006121 | Background | Harris 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. |
| 35756988 | Background | Bamonti 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. |
| 39826533 | Background | Ogawa 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. |
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| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
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| Sex: Female, Male | Self-Reported Sex | Count of Participants | Participants |
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| Race (NIH/OMB) | Self-Reported Race | Count of Participants | Participants |
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| Walking Speed | Usual walking speed, continuous | 1 participant completed only partial visit. | Mean | Standard Deviation | m/s |
|
| Short Physical Performance Battery | Point Scale ranging from 0 to 12 (best) | Mean | Standard Deviation | points on a scale |
|
| Modified Stair Climb Power | Watts per kilogram | Mean | Standard Deviation | W/Kg |
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| Trunk Muscle Endurance | Seconds per kilogram: Time is measured by holding a fixed position of trunk extension, weight taken at same visit as measure | Mean | Standard Deviation | seconds per kg |
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| Self-Efficacy for Exercise Scale | Self-report rating of self-efficacy, 0 - 100 point scale with higher scores indicating greater self-efficacy | Mean | Standard Deviation | points on a scale |
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| Stance Time Variability | This is the standard deviation of stance time measure by the Zeno Gait Mat PKMAS software system | Mean | Standard Deviation | Seconds |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Lower Extremity Power | Lower extremity power measure will be assessed via the modified stair climb test. | Differences due to COVID restricted visits that were remote, study drop outs, and assessor errors. | Posted | Mean | Standard Deviation | Watts/kg | Randomization to 8 weeks (comparing intervention to wait list groups) |
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|
|
| Secondary | 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. | Differences due to COVID restricted study visits that were remote, study drop out, and assessor errors. | Posted | Mean | Standard Deviation | seconds/kg | Randomization to 8 weeks (comparing intervention to wait list groups) |
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| Secondary | 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. | Differences due to COVID restricted study visits being remote, equipment failure, study drop out, and assessor errors. Only included participants who demonstrated variability in the walking pattern. | Posted | Mean | Standard Deviation | Seconds | Randomization to 8 weeks (comparing intervention to wait list groups) |
|
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| Other Pre-specified | Cognition - Delis-Kaplan Executive Function Systems (DKEFS) Verbal Fluency | A cognitive battery, including the DKEFS verbal fluency will be assessed pre and post intervention (within 2 weeks). Raw scores are used for each sub-test. The mean change in the raw score over the 8 weeks is reported.
| Differences due to COVID restricted study visits resulting in remote visits, study drop outs, and assessor errors. | Posted | Mean | Standard Deviation | score on a scale | Randomization to 8 weeks (comparing intervention to wait list groups) |
|
|
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| Other Pre-specified | Cognition- DKEFS Trail Making Test | The DKEFS Trail Making Test used conditions 2 and 4. Time to complete was used to calculate the mean change over the 8-weeks. Mean change in time to complete each condition are reported. | COVID-restricted visits; unable to complete cognitive task | Posted | Mean | Standard Deviation | Time (seconds) | Randomization to 8 weeks (comparing intervention to wait list) |
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| Other Pre-specified | Adherence | Adherence will be assessed by drop out status during the intervention period for each group respectively. This will be scored as a yes or no variable. | 1 participant did not complete a full visit in the wait list group. | Posted | Count of Participants | Participants | Intervention Period (8-weeks) |
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| Other Pre-specified | Compliance | Compliance with be assessed by the number of intervention sessions attended (out of 10). | Differences due to study drop outs (18 drop outs within the group randomized to treat; 6 drop outs from the group randomized to the wait list) during the intervention period. Study arms are combined as both groups received the same LLWS PT intervention, both groups consented to received 10 1-hour sessions over an 8-week period. Understanding the role that the intervention schedule has with overall compliance to the LLWS structure was desired. | Posted | Mean | Standard Deviation | Exercise Sessions | Intervention Period (8-weeks) |
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| 74 |
| 0 |
| 74 |
| 2 |
| 74 |
| EG001 | Waitlist Control-Live Long Walk Strong | Group randomized to the wait list for 8 weeks, then completed 8 weeks of LLWS PT intervention | 0 | 76 | 0 | 76 | 2 | 76 |
| EG002 | Waitlist Control-No Intervention (8 Weeks) | Group randomized to the wait list for 8 weeks | 0 | 76 | 0 | 76 | 0 | 76 |
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| Excessive Fatigue following exercise | Musculoskeletal and connective tissue disorders | Systematic Assessment | Increased Fatigue Following Exercise |
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| Abnormal vital signs | Musculoskeletal and connective tissue disorders | Systematic Assessment | Abnormal Vital signs prior to exercise |
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| Hip Pain after exercise testing | Musculoskeletal and connective tissue disorders | Systematic Assessment | Hip Pain following exercise testing |
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| Verbal Fluency: Category Switching Raw Score |
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| Verbal Fluency: Category Switching Accuracy Raw Score |
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