Mobility Limitation
Conditions
Keywords
Rehabilitation, Aging, Mobility Skills
Brief summary
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.
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.
Interventions
OTHERLive 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Participants are randomized through block permuted generated lists performed by the study biostatistician.
Intervention model description
Participants are assigned to 8 week Live Long Walk Strong (LLWS) rehabilitation or 8 week wait list control and then the LLWS rehabilitation program. The study is viewed as a randomized controlled trial comparing 8 weeks of LLWS rehabilitation to 8 weeks of wait list control. The long term follow up on the study, that occurs after the intervention is delivered to both groups, combines the cohort to examine the long term benefits of LLWS care.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking Speed | Randomization to 8 weeks (comparing intervention to wait list) | Walking (gait) speed is assessed as usual walking pace over a 4-meter course. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lower Extremity Power | Randomization to 8 weeks (comparing intervention to wait list groups) | Lower extremity power measure will be assessed via the modified stair climb test. |
| Trunk Muscle Endurance | 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. |
| Gait Variability | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJonathan F. Bean, MD
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Participant flow
Recruitment details
Veterans within VA Boston Healthcare System 50 years and older Walking Speed between 0.5 m/s and 1.0 m/s Short Physical Performance Battery \> 4/12
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 71.6 years STANDARD_DEVIATION 11.6 |
| Modified Stair Climb Power | 7.9 W/Kg STANDARD_DEVIATION 2.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 65 Participants |
| Self-Efficacy for Exercise Scale | 66.2 points on a scale STANDARD_DEVIATION 18.1 |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 129 Participants |
| Short Physical Performance Battery | 8.9 points on a scale STANDARD_DEVIATION 2.3 |
| Stance Time Variability | 0.040 Seconds STANDARD_DEVIATION 0.021 |
| Trunk Muscle Endurance | 0.52 seconds per kg STANDARD_DEVIATION 0.5 |
| Walking Speed | 9.0 m/s STANDARD_DEVIATION 2.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 76 | 0 / 76 |
| other Total, other adverse events | 2 / 74 | 2 / 76 | 0 / 76 |
| serious Total, serious adverse events | 0 / 74 | 0 / 76 | 0 / 76 |
Outcome results
None listed