Trial Outcomes & Findings for Exercise Rehabilitation in Veterans With PAD (NCT NCT02607046)
NCT ID: NCT02607046
Last Updated: 2024-01-18
Results Overview
Test of Mobility Function (minimum score = 0; maximum score = 36; higher score associated with better outcome)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
3 months
Results posted on
2024-01-18
Participant Flow
56 participants enrolled; only 35 participants completed baseline testing and were randomized.
Participant milestones
| Measure |
Exercise
Exercise Training
Exercise training: The exercise program includes supervised treadmill walking and home-based walking exercise.
|
NMES
Neuromuscular Electrical Stimulation
NMES: This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
13
|
|
Overall Study
COMPLETED
|
14
|
10
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise Rehabilitation in Veterans With PAD
Baseline characteristics by cohort
| Measure |
Exercise
n=22 Participants
Exercise Training
Exercise training: The exercise program includes supervised treadmill walking and home-based walking exercise.
|
NMES
n=13 Participants
Neuromuscular Electrical Stimulation
NMES: This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
69.7 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
67.8 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Modified Physical Performance Test
|
30.8 scores on a scale
STANDARD_DEVIATION 3.5 • n=5 Participants
|
30.7 scores on a scale
STANDARD_DEVIATION 3.0 • n=7 Participants
|
30.8 scores on a scale
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Six-minute Walk Distance
|
1237 feet
STANDARD_DEVIATION 328 • n=5 Participants
|
1070 feet
STANDARD_DEVIATION 325 • n=7 Participants
|
1164 feet
STANDARD_DEVIATION 330 • n=5 Participants
|
|
Muscle Perfusion Measured by Ultrasound Scan
|
4.57 units on a scale
STANDARD_DEVIATION 1.98 • n=5 Participants
|
3.90 units on a scale
STANDARD_DEVIATION 2.01 • n=7 Participants
|
4.28 units on a scale
STANDARD_DEVIATION 1.90 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsTest of Mobility Function (minimum score = 0; maximum score = 36; higher score associated with better outcome)
Outcome measures
| Measure |
Exercise
n=14 Participants
Exercise Training
Exercise training: The exercise program includes supervised treadmill walking and home-based walking exercise.
|
NMES
n=10 Participants
Neuromuscular Electrical Stimulation
NMES: This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs.
|
|---|---|---|
|
Modified Physical Performance Test
|
31.8 scores on a scale
Standard Deviation 5.2
|
32.3 scores on a scale
Standard Deviation 3.0
|
PRIMARY outcome
Timeframe: 3 monthsTest of ambulatory capacity
Outcome measures
| Measure |
Exercise
n=14 Participants
Exercise Training
Exercise training: The exercise program includes supervised treadmill walking and home-based walking exercise.
|
NMES
n=10 Participants
Neuromuscular Electrical Stimulation
NMES: This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs.
|
|---|---|---|
|
Six-minute Walk Distance
|
1295 feet
Standard Deviation 287
|
1193 feet
Standard Deviation 191
|
SECONDARY outcome
Timeframe: 3 monthsCalf Muscle Perfusion assessed as digital video intensity from recorded ultrasound scans. Units are scale data with a minimum = 0 and no predetermined maximum. Higher score = more perfusion.
Outcome measures
| Measure |
Exercise
n=14 Participants
Exercise Training
Exercise training: The exercise program includes supervised treadmill walking and home-based walking exercise.
|
NMES
n=10 Participants
Neuromuscular Electrical Stimulation
NMES: This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs.
|
|---|---|---|
|
Muscle Perfusion Measured by Ultrasound Scan
|
6.13 units on a scale
Standard Deviation 4.75
|
4.59 units on a scale
Standard Deviation 2.49
|
Adverse Events
Exercise
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
NMES
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exercise
n=22 participants at risk
Exercise Training
Exercise training: The exercise program includes supervised treadmill walking and home-based walking exercise.
|
NMES
n=13 participants at risk
Neuromuscular Electrical Stimulation
NMES: This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs.
|
|---|---|---|
|
Cardiac disorders
Chest Pain
|
4.5%
1/22 • Number of events 1 • 3 months
|
0.00%
0/13 • 3 months
|
Other adverse events
| Measure |
Exercise
n=22 participants at risk
Exercise Training
Exercise training: The exercise program includes supervised treadmill walking and home-based walking exercise.
|
NMES
n=13 participants at risk
Neuromuscular Electrical Stimulation
NMES: This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs.
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
4.5%
1/22 • Number of events 1 • 3 months
|
0.00%
0/13 • 3 months
|
|
Endocrine disorders
Elevated Blood Glucose
|
4.5%
1/22 • Number of events 1 • 3 months
|
0.00%
0/13 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Cyst
|
0.00%
0/22 • 3 months
|
7.7%
1/13 • Number of events 1 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Toe injury
|
4.5%
1/22 • Number of events 1 • 3 months
|
0.00%
0/13 • 3 months
|
|
Vascular disorders
Hypotension
|
4.5%
1/22 • Number of events 1 • 3 months
|
0.00%
0/13 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place