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Completed

NCT Number: NCT04026503

Live Long Walk Strong (LLWS) 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.

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Key information

Conditions

Mobility Limitation Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

    • Verbal Fluency: Letter Fluency total subscale score 6-83, with higher scores indicating a better outcome.
    • Verbal Fluency: Category Fluency total subscale score 17-63, with higher scores indicating a better outcome.
    • Verbal Fluency: Category Switching total subscale score 2-20, with higher scores indicating a better outcome.
    • Verbal Fluency: Category Switching total subscale score 1-21, with higher scores indicating a better outcome.

  2. 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.

  3. 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.

  4. Compliance

    Time frame: Intervention Period (8-weeks)

    Compliance with be assessed by the number of intervention sessions attended (out of 10).

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

The Live Long Walk Strong Rehabilitation Program: What Features Improve Mobility Skills?

Acronym: LLWS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2019
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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