Clinical trial NCT04026503: Live Long Walk Strong (LLWS) Rehabilitation Program: What Features Improve Mobility Skills
Official title: The Live Long Walk Strong Rehabilitation Program: What Features Improve Mobility Skills?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobility Limitation
Keywords: Rehabilitation
Aging
Mobility Skills
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-07-19
Enrollment: 151
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to 8 week Live Long Walk Strong rehabilitation or 8 week wait list control then the LLWS rehabilitation program.
Primary purpose: TREATMENT

Brief summary: This study is being performed to evaluate the efficacy of the Live Long Walk Strong rehabilitation program in Veterans 50 years and older. This study will also examine the features of the program that contribute to improved gait speed.

Detailed description: Due to COVID-19, currently completed a virtual version of the LLWS intervention study.

The investigators are currently recruiting for the original study design in-person.

This study is 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.

Eligibility criteria: 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

Primary outcomes:
measure: Gait Speed
timeFrame: within 2 weeks, 8 weeks, 16 weeks follow up
Secondary outcomes:
measure: Lower Extremity Power
timeFrame: within 2 weeks, 8 weeks, 16 weeks follow up
measure: Trunk Muscle Endurance
timeFrame: within 2 weeks, 8 weeks, 16 weeks follow up
measure: Gait Variability
timeFrame: within 2 weeks, 8 weeks, 16 weeks follow up
Other outcomes:
measure: Cognition
timeFrame: Within 2 weeks of intervention end
measure: Adherence
timeFrame: Within 2 weeks of intervention end
measure: Compliance
timeFrame: 16 weeks follow up
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Jonathan F. Bean, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Ganguly A, Hampton T. Calcium-dependence of serotonin-mediated aldosterone secretion and differential effects of calcium antagonists. Life Sci. 1985 Apr 15;36(15):1459-64. doi: 10.1016/0024-3205(85)90053-0.
citation: 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 17:1-8. doi: 10.1123/japa.2023-0446. Online ahead of print.