Trial Outcomes & Findings for Live Long Walk Strong (LLWS) Rehabilitation Program: What Features Improve Mobility Skills (NCT NCT04026503)
NCT ID: NCT04026503
Last Updated: 2026-02-20
Results Overview
Walking (gait) speed is assessed as usual walking pace over a 4-meter course.
COMPLETED
NA
151 participants
Randomization to 8 weeks (comparing intervention to wait list)
2026-02-20
Participant Flow
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
Participant milestones
| Measure |
Live Long Walk Strong
8 week rehabilitation program: 10 1-hour sessions over 8 weeks.
Participants were followed after the completion of the intervention in this manner:
Post 1 visit occurring within 2 weeks after the intervention ended Post 2 visit occurring 8 weeks after the intervention ended Post 3 occurring 16 weeks after the intervention ended
|
8 Week Wait List Control
8 week wait list control; following the 8 weeks participants completed a repeat baseline visit.
Participants were then given 8 weeks of the Live Long Walk Strong rehabilitation program (10 1-hour sessions).
Participants were followed after the completion of the intervention in this manner:
Post 1 visit occurring within 2 weeks after the intervention ended Post 2 visit occurring 8 weeks after the intervention ended Post 3 occurring 16 weeks after the intervention ended
|
|---|---|---|
|
Randomize to 8 Weeks (LLWS PT or Wait)
STARTED
|
74
|
76
|
|
Randomize to 8 Weeks (LLWS PT or Wait)
COMPLETED
|
56
|
58
|
|
Randomize to 8 Weeks (LLWS PT or Wait)
NOT COMPLETED
|
18
|
18
|
|
Wait List Control Receives LLWS PT
STARTED
|
0
|
58
|
|
Wait List Control Receives LLWS PT
COMPLETED
|
0
|
52
|
|
Wait List Control Receives LLWS PT
NOT COMPLETED
|
0
|
6
|
|
Post 1 Both Groups Post LLWS PT
STARTED
|
74
|
52
|
|
Post 1 Both Groups Post LLWS PT
COMPLETED
|
56
|
52
|
|
Post 1 Both Groups Post LLWS PT
NOT COMPLETED
|
18
|
0
|
|
Post 2 Both Groups 8 Weeks Post LLWS PT
STARTED
|
56
|
52
|
|
Post 2 Both Groups 8 Weeks Post LLWS PT
COMPLETED
|
51
|
49
|
|
Post 2 Both Groups 8 Weeks Post LLWS PT
NOT COMPLETED
|
5
|
3
|
|
Post 3 Both Groups 16 Weeks Post LLWS PT
STARTED
|
51
|
49
|
|
Post 3 Both Groups 16 Weeks Post LLWS PT
COMPLETED
|
49
|
49
|
|
Post 3 Both Groups 16 Weeks Post LLWS PT
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
1 participant completed only partial visit.
Baseline characteristics by cohort
| Measure |
Live Long Walk Strong
n=74 Participants
Group randomized to 8 week rehabilitation program (10 1-hour sessions over 8 weeks)
|
8 Week Wait List Control
n=76 Participants
Group randomized to 8 week wait list then followed by 8 weeks of the Live Long Walk Strong rehabilitation program ( (10 1-hour sessions over 8 weeks)
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.6 years
STANDARD_DEVIATION 8.9 • n=14 Participants
|
71.6 years
STANDARD_DEVIATION 11.6 • n=14 Participants
|
70.6 years
STANDARD_DEVIATION 10.3 • n=29 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=14 Participants
|
10 Participants
n=14 Participants
|
21 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=14 Participants
|
66 Participants
n=14 Participants
|
129 Participants
n=29 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
3 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=14 Participants
|
9 Participants
n=14 Participants
|
19 Participants
n=29 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=14 Participants
|
65 Participants
n=14 Participants
|
123 Participants
n=29 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=14 Participants
|
2 Participants
n=14 Participants
|
4 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=29 Participants
|
|
Walking Speed
|
9.0 m/s
STANDARD_DEVIATION 2.4 • n=14 Participants • 1 participant completed only partial visit.
|
8.9 m/s
STANDARD_DEVIATION 2.3 • n=14 Participants • 1 participant completed only partial visit.
|
8.9 m/s
STANDARD_DEVIATION 2.3 • n=29 Participants • 1 participant completed only partial visit.
|
|
Short Physical Performance Battery
|
9.0 points on a scale
STANDARD_DEVIATION 2.4 • n=14 Participants
|
8.9 points on a scale
STANDARD_DEVIATION 2.3 • n=14 Participants
|
8.9 points on a scale
STANDARD_DEVIATION 2.3 • n=29 Participants
|
|
Modified Stair Climb Power
|
7.9 W/Kg
STANDARD_DEVIATION 2.4 • n=14 Participants
|
7.1 W/Kg
STANDARD_DEVIATION 1.9 • n=14 Participants
|
7.5 W/Kg
STANDARD_DEVIATION 2.2 • n=29 Participants
|
|
Trunk Muscle Endurance
|
0.54 seconds per kg
STANDARD_DEVIATION 0.51 • n=14 Participants
|
0.50 seconds per kg
STANDARD_DEVIATION 0.49 • n=14 Participants
|
0.52 seconds per kg
STANDARD_DEVIATION 0.50 • n=29 Participants
|
|
Self-Efficacy for Exercise Scale
|
66.2 points on a scale
STANDARD_DEVIATION 18.1 • n=14 Participants
|
66.1 points on a scale
STANDARD_DEVIATION 17.8 • n=14 Participants
|
66.2 points on a scale
STANDARD_DEVIATION 17.9 • n=29 Participants
|
|
Stance Time Variability
|
0.041 Seconds
STANDARD_DEVIATION 0.022 • n=14 Participants
|
0.040 Seconds
STANDARD_DEVIATION 0.021 • n=14 Participants
|
0.040 Seconds
STANDARD_DEVIATION 0.021 • n=29 Participants
|
PRIMARY outcome
Timeframe: Randomization to 8 weeks (comparing intervention to wait list)Population: Differences due to study drop outs, COVID restricted study visits that resulted in remote assessment only, equipment failure, and assessor error.
Walking (gait) speed is assessed as usual walking pace over a 4-meter course.
Outcome measures
| Measure |
8 Week Wait List Control
n=58 Participants
8 week wait list then followed by 8 weeks of the Live Long Walk Strong rehabilitation program
|
Live Long Walk Strong
n=51 Participants
8 week rehabilitation program
|
|---|---|---|
|
Walking Speed
|
0.91 m/s
Standard Deviation 0.02
|
0.86 m/s
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: Randomization to 8 weeks (comparing intervention to wait list groups)Population: Differences due to COVID restricted visits that were remote, study drop outs, and assessor errors.
Lower extremity power measure will be assessed via the modified stair climb test.
Outcome measures
| Measure |
8 Week Wait List Control
n=53 Participants
8 week wait list then followed by 8 weeks of the Live Long Walk Strong rehabilitation program
|
Live Long Walk Strong
n=47 Participants
8 week rehabilitation program
|
|---|---|---|
|
Lower Extremity Power
|
7.3 Watts/kg
Standard Deviation 2.1
|
8.2 Watts/kg
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Randomization to 8 weeks (comparing intervention to wait list groups)Population: Differences due to COVID restricted study visits that were remote, study drop out, and assessor errors.
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.
Outcome measures
| Measure |
8 Week Wait List Control
n=52 Participants
8 week wait list then followed by 8 weeks of the Live Long Walk Strong rehabilitation program
|
Live Long Walk Strong
n=45 Participants
8 week rehabilitation program
|
|---|---|---|
|
Trunk Muscle Endurance
|
0.59 seconds/kg
Standard Deviation 0.6
|
0.704 seconds/kg
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: Randomization to 8 weeks (comparing intervention to wait list groups)Population: Differences due to COVID restricted study visits being remote, equipment failure, study drop out, and assessor errors. Only included participants who demonstrated variability in the walking pattern.
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.
Outcome measures
| Measure |
8 Week Wait List Control
n=36 Participants
8 week wait list then followed by 8 weeks of the Live Long Walk Strong rehabilitation program
|
Live Long Walk Strong
n=42 Participants
8 week rehabilitation program
|
|---|---|---|
|
Gait Variability
|
0.05 Seconds
Standard Deviation 0.02
|
0.04 Seconds
Standard Deviation 0.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomization to 8 weeks (comparing intervention to wait list groups)Population: Differences due to COVID restricted study visits resulting in remote visits, study drop outs, and assessor errors.
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.
Outcome measures
| Measure |
8 Week Wait List Control
n=53 Participants
8 week wait list then followed by 8 weeks of the Live Long Walk Strong rehabilitation program
|
Live Long Walk Strong
n=50 Participants
8 week rehabilitation program
|
|---|---|---|
|
Cognition - Delis-Kaplan Executive Function Systems (DKEFS) Verbal Fluency
Verbal Fluency: Letter Fluency Raw Score
|
-1.6 score on a scale
Standard Deviation 7.7
|
1.8 score on a scale
Standard Deviation 8.0
|
|
Cognition - Delis-Kaplan Executive Function Systems (DKEFS) Verbal Fluency
Verbal Fluency: Category Fluency Raw Score
|
-2.9 score on a scale
Standard Deviation 6.5
|
1.2 score on a scale
Standard Deviation 6.2
|
|
Cognition - Delis-Kaplan Executive Function Systems (DKEFS) Verbal Fluency
Verbal Fluency: Category Switching Raw Score
|
0.004 score on a scale
Standard Deviation 3.4
|
0.02 score on a scale
Standard Deviation 2.5
|
|
Cognition - Delis-Kaplan Executive Function Systems (DKEFS) Verbal Fluency
Verbal Fluency: Category Switching Accuracy Raw Score
|
0 score on a scale
Standard Deviation 3.5
|
0.3 score on a scale
Standard Deviation 3.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomization to 8 weeks (comparing intervention to wait list)Population: COVID-restricted visits; unable to complete cognitive task
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.
Outcome measures
| Measure |
8 Week Wait List Control
n=41 Participants
8 week wait list then followed by 8 weeks of the Live Long Walk Strong rehabilitation program
|
Live Long Walk Strong
n=45 Participants
8 week rehabilitation program
|
|---|---|---|
|
Cognition- DKEFS Trail Making Test
Condition 2
|
-1.8 Time (seconds)
Standard Deviation 21.1
|
-5.2 Time (seconds)
Standard Deviation 13.1
|
|
Cognition- DKEFS Trail Making Test
Condition 4
|
-2.2 Time (seconds)
Standard Deviation 37.3
|
0.8 Time (seconds)
Standard Deviation 38.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Intervention Period (8-weeks)Population: 1 participant did not complete a full visit in the wait list group.
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.
Outcome measures
| Measure |
8 Week Wait List Control
n=58 Participants
8 week wait list then followed by 8 weeks of the Live Long Walk Strong rehabilitation program
|
Live Long Walk Strong
n=74 Participants
8 week rehabilitation program
|
|---|---|---|
|
Adherence
"No" to Drop Out Status (Adherent to program)
|
52 Participants
|
56 Participants
|
|
Adherence
"Yes" to Drop out Status (Non-Adherent to program)
|
6 Participants
|
18 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Intervention Period (8-weeks)Population: Differences due to study drop outs (18 drop outs within the group randomized to treat; 6 drop outs from the group randomized to the wait list) during the intervention period. Study arms are combined as both groups received the same LLWS PT intervention, both groups consented to received 10 1-hour sessions over an 8-week period. Understanding the role that the intervention schedule has with overall compliance to the LLWS structure was desired.
Compliance with be assessed by the number of intervention sessions attended (out of 10).
Outcome measures
| Measure |
8 Week Wait List Control
8 week wait list then followed by 8 weeks of the Live Long Walk Strong rehabilitation program
|
Live Long Walk Strong
n=132 Participants
8 week rehabilitation program
|
|---|---|---|
|
Compliance
|
—
|
9.3 Exercise Sessions
Standard Deviation 1.6
|
Adverse Events
Live Long Walk Strong
Waitlist Control-Live Long Walk Strong
Waitlist Control-No Intervention (8 Weeks)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Live Long Walk Strong
n=74 participants at risk
Group Randomized to LLWS treatment for 8 weeks
|
Waitlist Control-Live Long Walk Strong
n=76 participants at risk
Group randomized to the wait list for 8 weeks, then completed 8 weeks of LLWS PT intervention
|
Waitlist Control-No Intervention (8 Weeks)
n=76 participants at risk
Group randomized to the wait list for 8 weeks
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Abnormal vital signs following exercise
|
0.00%
0/74 • From Enrollment to 16 weeks of follow-up after the intervention (24 weeks total)
|
1.3%
1/76 • Number of events 1 • From Enrollment to 16 weeks of follow-up after the intervention (24 weeks total)
|
0.00%
0/76 • From Enrollment to 16 weeks of follow-up after the intervention (24 weeks total)
|
|
Musculoskeletal and connective tissue disorders
Excessive Fatigue following exercise
|
0.00%
0/74 • From Enrollment to 16 weeks of follow-up after the intervention (24 weeks total)
|
1.3%
1/76 • Number of events 1 • From Enrollment to 16 weeks of follow-up after the intervention (24 weeks total)
|
0.00%
0/76 • From Enrollment to 16 weeks of follow-up after the intervention (24 weeks total)
|
|
Musculoskeletal and connective tissue disorders
Abnormal vital signs
|
1.4%
1/74 • Number of events 1 • From Enrollment to 16 weeks of follow-up after the intervention (24 weeks total)
|
0.00%
0/76 • From Enrollment to 16 weeks of follow-up after the intervention (24 weeks total)
|
0.00%
0/76 • From Enrollment to 16 weeks of follow-up after the intervention (24 weeks total)
|
|
Musculoskeletal and connective tissue disorders
Hip Pain after exercise testing
|
1.4%
1/74 • Number of events 1 • From Enrollment to 16 weeks of follow-up after the intervention (24 weeks total)
|
0.00%
0/76 • From Enrollment to 16 weeks of follow-up after the intervention (24 weeks total)
|
0.00%
0/76 • From Enrollment to 16 weeks of follow-up after the intervention (24 weeks total)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place