- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04026503
Live Long Walk Strong (LLWS) Rehabilitation Program: What Features Improve Mobility Skills (LLWS)
The Live Long Walk Strong Rehabilitation Program: What Features Improve Mobility Skills?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02130-4817
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
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:
- peripheral neurologic impairment
- orthopedic impairment
- visual impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Live Long Walk Strong
8 week rehabilitation program
|
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.
|
|
Active Comparator: 8 week wait list control
8 week wait list then followed by 8 weeks of the Live Long Walk Strong rehabilitation program
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Randomization to 8 weeks (comparing intervention to wait list)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lower Extremity Power
Time Frame: Randomization to 8 weeks (comparing intervention to wait list groups)
|
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
Time Frame: Randomization to 8 weeks (comparing intervention to wait list groups)
|
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
Time Frame: Randomization to 8 weeks (comparing intervention to wait list groups)
|
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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognition - Delis-Kaplan Executive Function Systems (DKEFS) Verbal Fluency
Time Frame: Randomization to 8 weeks (comparing intervention to wait list groups)
|
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.
|
Randomization to 8 weeks (comparing intervention to wait list groups)
|
|
Cognition- DKEFS Trail Making Test
Time Frame: Randomization to 8 weeks (comparing intervention to wait list)
|
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
Time Frame: Intervention Period (8-weeks)
|
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
Time Frame: Intervention Period (8-weeks)
|
Compliance with be assessed by the number of intervention sessions attended (out of 10).
|
Intervention Period (8-weeks)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jonathan F. Bean, MD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E3095-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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