Live Long Walk Strong (LLWS) Rehabilitation Program: What Features Improve Mobility Skills

Mobility Limitation Clinical Trial

— LLWS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04026503
• Other study ID #: E3095-R
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: VA Office of Research and Development
• Contact: Jonathan F Bean, MD
• Phone: (857) 364-2786
• Email: Jonathan.Bean4[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mobility Limitation

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognition	A cognitive battery, including the DKEFS verbal fluency and DKEFS trail making tests will be assessed pre and post intervention (within 2 weeks). For all tests both scaled scores (1-19) will be reported. For DKEFS trail making tests raw scores will also be reported.	Within 2 weeks of intervention end
Other	Adherence	Adherence will be assessed by drop out status from the study between enrollment and the first follow up visit (2 weeks post intervention), defined as a yes or no status.	Within 2 weeks of intervention end
Other	Compliance	Compliance with be assessed separately by the number of intervention sessions attended (out of 10) and the number of reported exercise days during follow up period (over 16-week time period).	16 weeks follow up
Primary	Gait Speed	Gait speed change will be assessed within 2 weeks post intervention and then in 8 and 16 weeks of subsequent follow-up.; Virtual only pilot assessing the feasibility of the LLWS program in a virtual format.	within 2 weeks, 8 weeks, 16 weeks follow up
Secondary	Lower Extremity Power	Lower extremity power measure will be assessed at 3 time points post intervention. Power will be assessed via a keiser machine (force) and stair climb test (seconds).	within 2 weeks, 8 weeks, 16 weeks follow up
Secondary	Trunk Muscle Endurance	Trunk muscle endurance will be measured at 3 time points post intervention. Trunk endurance will be assessed via saunders table through time (seconds) held in a fixed position.	within 2 weeks, 8 weeks, 16 weeks follow up
Secondary	Gait Variability	Gait variability will be measured at 3 time points post intervention. 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.	within 2 weeks, 8 weeks, 16 weeks follow up