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

Primary Purpose

Mobility Limitation

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Live Long Walk Strong rehabilitation program

About this trial

This is an interventional treatment trial for Mobility Limitation focused on measuring Rehabilitation, Aging, Mobility Skills

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Live Long Walk Strong

8 week wait list control

Arm Description

8 week rehabilitation program

8 week wait list then followed by 8 weeks of the Live Long Walk Strong rehabilitation program

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

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.

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.

Full Information

NCT ID

NCT04026503

First Posted

July 18, 2019

Last Updated

October 4, 2023

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT04026503

Brief Title

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

Acronym

LLWS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 21, 2021 (Actual)

Primary Completion Date

September 30, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

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.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mobility Limitation

Keywords

Rehabilitation, Aging, Mobility Skills

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Participants are assigned to 8 week Live Long Walk Strong rehabilitation or 8 week wait list control then the LLWS rehabilitation program.

Masking

InvestigatorOutcomes Assessor

Masking Description

Participants are randomized through block permuted generated lists performed by the study biostatistician.

Allocation

Randomized

Enrollment

198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Live Long Walk Strong

Arm Type

Experimental

Arm Description

8 week rehabilitation program

Arm Title

8 week wait list control

Arm Type

Active Comparator

Arm Description

8 week wait list then followed by 8 weeks of the Live Long Walk Strong rehabilitation program

Intervention Type

Other

Intervention Name(s)

Live Long Walk Strong rehabilitation program

Intervention Description

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 Outcome Measure Information:

Title

Gait Speed

Description

Time Frame

within 2 weeks, 8 weeks, 16 weeks follow up

Secondary Outcome Measure Information:

Title

Lower Extremity Power

Description

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).

Time Frame

within 2 weeks, 8 weeks, 16 weeks follow up

Title

Trunk Muscle Endurance

Description

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.

Time Frame

within 2 weeks, 8 weeks, 16 weeks follow up

Title

Gait Variability

Description

Time Frame

within 2 weeks, 8 weeks, 16 weeks follow up

Other Pre-specified Outcome Measures:

Title

Cognition

Description

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.

Time Frame

Within 2 weeks of intervention end

Title

Adherence

Description

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.

Time Frame

Within 2 weeks of intervention end

Title

Compliance

Description

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).

Time Frame

16 weeks follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jonathan F Bean, MD

Phone

(857) 364-2786

Jonathan.Bean4@va.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan F. Bean, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02130-4817

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jonathan F Bean, MD

Phone

857-364-2786

Jonathan.Bean4@va.gov

First Name & Middle Initial & Last Name & Degree

Rebekah Harris, PhD DPT PT

Phone

(857) 364-2785

rebekah.harris@va.gov

First Name & Middle Initial & Last Name & Degree

Jonathan F. Bean, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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