Trial Outcomes & Findings for Locomotor Experience Applied Post Stroke Trial (NCT NCT00243919)
NCT ID: NCT00243919
Last Updated: 2014-07-16
Results Overview
Success: walking greater than 0.4 m/sec if baseline was less than 0.4; walking greater than 0.8 m/sec if baseline was 0.4m/sec or greater but less than 0.8 m/sec as measured during 10 meter walk.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
408 participants
Primary outcome timeframe
12 months post-stroke
Results posted on
2014-07-16
Participant Flow
Participants were recruited from 6 inpatient rehabilitation centers in California and Florida from April 2006 through June 2009.
Participants admitted for inpatient rehabilitation were screened by chart review. Eligible participants with first-time stroke received a comprehensive medical record review and physical and cognitive screening. At 2-months, those who maintained eligibility and successfully completed an exercise tolerance test were enrolled.
Participant milestones
| Measure |
Early Locomotor Training Program
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
|
Late Locomotor Training Program
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
|
Home Exercise Program
Home Exercise Program (HEP) was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
|
|---|---|---|---|
|
Overall Study
STARTED
|
139
|
143
|
126
|
|
Overall Study
COMPLETED
|
122
|
125
|
115
|
|
Overall Study
NOT COMPLETED
|
17
|
18
|
11
|
Reasons for withdrawal
| Measure |
Early Locomotor Training Program
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
|
Late Locomotor Training Program
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
|
Home Exercise Program
Home Exercise Program (HEP) was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
|
|---|---|---|---|
|
Overall Study
Death
|
3
|
4
|
6
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
2
|
|
Overall Study
Lost to Follow-up
|
6
|
7
|
3
|
|
Overall Study
Administrative Error
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
Baseline Characteristics
Locomotor Experience Applied Post Stroke Trial
Baseline characteristics by cohort
| Measure |
Early Locomotor Training Program
n=139 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
|
Late Locomotor Training Program
n=143 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
|
Home Exercise Program
n=126 Participants
HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
|
Total
n=408 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
62.6 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
184 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
224 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
113 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
345 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
236 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Time since stroke to randomization - days
|
64.1 days
STANDARD_DEVIATION 8.3 • n=5 Participants
|
64.18 days
STANDARD_DEVIATION 9.0 • n=7 Participants
|
62.9 days
STANDARD_DEVIATION 8.0 • n=5 Participants
|
63.8 days
STANDARD_DEVIATION 8.5 • n=4 Participants
|
|
Side of involvement
Left Hemiparesis
|
63 participants
n=5 Participants
|
58 participants
n=7 Participants
|
61 participants
n=5 Participants
|
182 participants
n=4 Participants
|
|
Side of involvement
Right Hemiparesis
|
76 participants
n=5 Participants
|
85 participants
n=7 Participants
|
65 participants
n=5 Participants
|
226 participants
n=4 Participants
|
|
Stroke Type
Large Vessel
|
55 participants
n=5 Participants
|
60 participants
n=7 Participants
|
47 participants
n=5 Participants
|
162 participants
n=4 Participants
|
|
Stroke Type
Lacune
|
40 participants
n=5 Participants
|
45 participants
n=7 Participants
|
43 participants
n=5 Participants
|
128 participants
n=4 Participants
|
|
Stroke Type
Hemorrhage
|
27 participants
n=5 Participants
|
22 participants
n=7 Participants
|
21 participants
n=5 Participants
|
70 participants
n=4 Participants
|
|
Stroke Type
Undefined
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
15 participants
n=5 Participants
|
48 participants
n=4 Participants
|
|
Modified Rankin Scale
Rankin 0 - 1 (no significant disability)
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Modified Rankin Scale
Rankin 2 (slight disability)
|
12 participants
n=5 Participants
|
21 participants
n=7 Participants
|
21 participants
n=5 Participants
|
54 participants
n=4 Participants
|
|
Modified Rankin Scale
Rankin 3 (moderate disability)
|
66 participants
n=5 Participants
|
57 participants
n=7 Participants
|
49 participants
n=5 Participants
|
172 participants
n=4 Participants
|
|
Modified Rankin Scale
Rankin 4 (moderately severe disability)
|
61 participants
n=5 Participants
|
63 participants
n=7 Participants
|
56 participants
n=5 Participants
|
180 participants
n=4 Participants
|
|
Comorbidities
Cardiovascular
|
36 participants
n=5 Participants
|
36 participants
n=7 Participants
|
37 participants
n=5 Participants
|
109 participants
n=4 Participants
|
|
Comorbidities
Hypertension
|
116 participants
n=5 Participants
|
111 participants
n=7 Participants
|
104 participants
n=5 Participants
|
331 participants
n=4 Participants
|
|
Comorbidities
Peripheral vascular disease
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
13 participants
n=5 Participants
|
37 participants
n=4 Participants
|
|
Comorbidities
Chronic Obstructive Pulmonary Disease (COPD)
|
5 participants
n=5 Participants
|
14 participants
n=7 Participants
|
7 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Comorbidities
Arthritis/other musculoskeletal
|
47 participants
n=5 Participants
|
52 participants
n=7 Participants
|
47 participants
n=5 Participants
|
146 participants
n=4 Participants
|
|
Comorbidities
Diabetes
|
47 participants
n=5 Participants
|
51 participants
n=7 Participants
|
43 participants
n=5 Participants
|
141 participants
n=4 Participants
|
|
Comorbidities
Depression (Personal Health Questionnaire-9 >= 10)
|
20 participants
n=5 Participants
|
28 participants
n=7 Participants
|
19 participants
n=5 Participants
|
67 participants
n=4 Participants
|
|
Mini Mental Status Exam
|
26.0 scores on a scale
STANDARD_DEVIATION 3.2 • n=5 Participants
|
26.2 scores on a scale
STANDARD_DEVIATION 3.7 • n=7 Participants
|
26.0 scores on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
26.1 scores on a scale
STANDARD_DEVIATION 3.5 • n=4 Participants
|
|
Walking Speed (m/sec)
Severe Disability (<0.4 m/sec)
|
75 participants
n=5 Participants
|
77 participants
n=7 Participants
|
66 participants
n=5 Participants
|
218 participants
n=4 Participants
|
|
Walking Speed (m/sec)
Moderate Disability (0.4 - 0.8 m/sec)
|
64 participants
n=5 Participants
|
66 participants
n=7 Participants
|
60 participants
n=5 Participants
|
190 participants
n=4 Participants
|
|
Comfortable walking speed (m/sec)
|
0.36 m/sec
STANDARD_DEVIATION 0.22 • n=5 Participants
|
0.38 m/sec
STANDARD_DEVIATION 0.23 • n=7 Participants
|
0.39 m/sec
STANDARD_DEVIATION 0.22 • n=5 Participants
|
0.38 m/sec
STANDARD_DEVIATION 0.22 • n=4 Participants
|
PRIMARY outcome
Timeframe: 12 months post-strokePopulation: Intention to treat analysis. Missing data were imputed using the LOCF method.
Success: walking greater than 0.4 m/sec if baseline was less than 0.4; walking greater than 0.8 m/sec if baseline was 0.4m/sec or greater but less than 0.8 m/sec as measured during 10 meter walk.
Outcome measures
| Measure |
Early Locomotor Training Program
n=139 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
|
Late Locomotor Training Program
n=143 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
|
Home Exercise Program
n=126 Participants
HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
|
|---|---|---|---|
|
Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke
|
50.4 percent of participants
|
53.8 percent of participants
|
51.6 percent of participants
|
PRIMARY outcome
Timeframe: Baseline and 12 months post-strokeOutcome measures
| Measure |
Early Locomotor Training Program
n=139 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
|
Late Locomotor Training Program
n=143 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
|
Home Exercise Program
n=126 Participants
HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
|
|---|---|---|---|
|
Walking Speed: Measured During a 10-meter Walk
Baseline
|
0.37 m/sec
Standard Deviation 0.22
|
0.38 m/sec
Standard Deviation 0.23
|
0.39 m/sec
Standard Deviation 0.22
|
|
Walking Speed: Measured During a 10-meter Walk
12-month change from Baseline
|
0.23 m/sec
Standard Deviation 0.20
|
0.24 m/sec
Standard Deviation 0.23
|
0.25 m/sec
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: Baseline and 6 months post-strokePopulation: Intention to treat analysis. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.
Success: walking greater than 0.4 m/sec if baseline was less than 0.4; walking greater than 0.8 m/sec if baseline was 0.4m/sec or greater but less than 0.8 m/sec as measured during 10 meter walk.
Outcome measures
| Measure |
Early Locomotor Training Program
n=139 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
|
Late Locomotor Training Program
n=143 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
|
Home Exercise Program
n=126 Participants
HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
|
|---|---|---|---|
|
Percentage of Patients Who Successfully Improved Functional Level of Walking at 6 Months Post-stroke
|
50.4 percent of participants
|
32.2 percent of participants
|
49.2 percent of participants
|
SECONDARY outcome
Timeframe: Baseline and 6 months post-strokeOutcome measures
| Measure |
Early Locomotor Training Program
n=139 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
|
Late Locomotor Training Program
n=143 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
|
Home Exercise Program
n=126 Participants
HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
|
|---|---|---|---|
|
6 Month Outcome: Walking Speed: Measured During a 10-meter Walk
Baseline
|
0.37 m/sec
Standard Deviation 0.22
|
0.38 m/sec
Standard Deviation 0.23
|
0.39 m/sec
Standard Deviation 0.22
|
|
6 Month Outcome: Walking Speed: Measured During a 10-meter Walk
6 month change from Baseline
|
0.25 m/sec
Standard Deviation 0.21
|
0.13 m/sec
Standard Deviation 0.14
|
0.23 m/sec
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 months post-strokeDistance walked in 6 minutes.
Outcome measures
| Measure |
Early Locomotor Training Program
n=139 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
|
Late Locomotor Training Program
n=143 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
|
Home Exercise Program
n=126 Participants
HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
|
|---|---|---|---|
|
6 Minute Walking Distance (Meters)
Baseline
|
124.1 meters
Standard Deviation 77.5
|
125.7 meters
Standard Deviation 81.8
|
126.3 meters
Standard Deviation 75.0
|
|
6 Minute Walking Distance (Meters)
6-month change from baseline
|
81.8 meters
Standard Deviation 62.8
|
41.0 meters
Standard Deviation 47.4
|
75.9 meters
Standard Deviation 69.3
|
|
6 Minute Walking Distance (Meters)
12-month change from baseline
|
73.2 meters
Standard Deviation 69.4
|
79.0 meters
Standard Deviation 75.1
|
85.2 meters
Standard Deviation 72.9
|
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 months post-strokeAs measured with a step activity monitor averaged over 2 days.
Outcome measures
| Measure |
Early Locomotor Training Program
n=139 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
|
Late Locomotor Training Program
n=143 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
|
Home Exercise Program
n=126 Participants
HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
|
|---|---|---|---|
|
Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day
Baseline
|
1468 steps
Interval 601.0 to 3889.0
|
1664 steps
Interval 647.0 to 3354.0
|
1882.5 steps
Interval 905.0 to 3384.0
|
|
Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day
6-month change from Baseline
|
1017 steps
Interval -102.0 to 2209.0
|
565.5 steps
Interval -362.0 to 2043.0
|
1357 steps
Interval 84.0 to 3382.0
|
|
Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day
12-month change from Baseline
|
858 steps
Interval -253.0 to 2422.0
|
1022 steps
Interval -111.0 to 3009.0
|
1471 steps
Interval 435.0 to 3481.0
|
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 months post-strokeRange = 0 - 100. The Stroke Impact Scale is a measure of function (including ADL-IADL and mobility) and quality of life (participation). The Participation Scale is a single domain of the Stroke Impact Scale in which participation is defined as the ability to engage in meaningful activities with 0 indicating inability to engage in any meaningful activities and 100 indicating the ability to fully engage in meaningful activities.
Outcome measures
| Measure |
Early Locomotor Training Program
n=139 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
|
Late Locomotor Training Program
n=143 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
|
Home Exercise Program
n=126 Participants
HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
|
|---|---|---|---|
|
Stroke Impact Scale (SIS) - Participation
6 month change from Baseline
|
11.8 units on a scale
Standard Deviation 26.8
|
7.7 units on a scale
Standard Deviation 20.5
|
14.7 units on a scale
Standard Deviation 22.9
|
|
Stroke Impact Scale (SIS) - Participation
Baseline
|
45.0 units on a scale
Standard Deviation 23.3
|
46.6 units on a scale
Standard Deviation 23.0
|
44.8 units on a scale
Standard Deviation 23.5
|
|
Stroke Impact Scale (SIS) - Participation
12 month change from Baseline
|
17.1 units on a scale
Standard Deviation 25.9
|
13.1 units on a scale
Standard Deviation 22.0
|
14.4 units on a scale
Standard Deviation 20.6
|
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 months post-strokeRange 0 - 100 The Stroke Impact Scale (SIS) is a measure of function including ADL/IADL. The ADL/IADL scale is a single domain of the Stroke Impact Scale in which ADL is defined as the ability to take care of basic needs and IADL is defined as the ability to perform activities that make it possible to live independently in the community, with 0 indicating complete dependence on others and 100 indicating the ability to live independently without difficulty.
Outcome measures
| Measure |
Early Locomotor Training Program
n=139 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
|
Late Locomotor Training Program
n=143 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
|
Home Exercise Program
n=126 Participants
HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
|
|---|---|---|---|
|
Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)
Baseline
|
54.1 units on a scale
Standard Deviation 20.1
|
55.7 units on a scale
Standard Deviation 20.4
|
54.4 units on a scale
Standard Deviation 20.7
|
|
Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)
6-month change from baseline
|
9.8 units on a scale
Standard Deviation 17.2
|
7.0 units on a scale
Standard Deviation 17.8
|
13.0 units on a scale
Standard Deviation 16.9
|
|
Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)
12-month change from baseline
|
9.6 units on a scale
Standard Deviation 19.5
|
9.4 units on a scale
Standard Deviation 17.2
|
14.5 units on a scale
Standard Deviation 19.0
|
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 months post-strokeRange = 0 - 100. The Stroke Impact Scale (SIS) is a measure of function including Mobility. The Mobility scale is a single domain of the Stroke Impact Scale which captures the ability to balance and move, with 0 indicating severe restrictions in balance and mobility and 100 indicating independence in mobility and balance.
Outcome measures
| Measure |
Early Locomotor Training Program
n=139 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
|
Late Locomotor Training Program
n=143 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
|
Home Exercise Program
n=126 Participants
HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
|
|---|---|---|---|
|
Stroke Impact Scale (SIS) - Mobility
12-month change from baseline
|
13.7 units on a scale
Standard Deviation 21.6
|
12.0 units on a scale
Standard Deviation 19.1
|
14.2 units on a scale
Standard Deviation 20.3
|
|
Stroke Impact Scale (SIS) - Mobility
Baseline
|
57.0 units on a scale
Standard Deviation 22.1
|
60.5 units on a scale
Standard Deviation 20.7
|
59.1 units on a scale
Standard Deviation 19.5
|
|
Stroke Impact Scale (SIS) - Mobility
6-month change from baseline
|
15.3 units on a scale
Standard Deviation 21.4
|
7.0 units on a scale
Standard Deviation 15.7
|
14.9 units on a scale
Standard Deviation 20.0
|
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 months post-strokeRange 0 - 34 The Fugl-Meyer Lower Extremity Score measures your ability to move the lower extremity with 0 indicating no movement and 34 indicating the ability to selectively move the lower extremity without difficulty.
Outcome measures
| Measure |
Early Locomotor Training Program
n=139 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
|
Late Locomotor Training Program
n=143 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
|
Home Exercise Program
n=126 Participants
HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
|
|---|---|---|---|
|
Fugl-Meyer Lower Extremity Score
6-month change from Baseline
|
2.2 units on a scale
Standard Deviation 3.4
|
1.3 units on a scale
Standard Deviation 3.3
|
2.4 units on a scale
Standard Deviation 4.1
|
|
Fugl-Meyer Lower Extremity Score
Baseline
|
23.7 units on a scale
Standard Deviation 6.7
|
24.8 units on a scale
Standard Deviation 6.4
|
24.7 units on a scale
Standard Deviation 6.3
|
|
Fugl-Meyer Lower Extremity Score
12-month change from Baseline
|
1.7 units on a scale
Standard Deviation 3.9
|
1.5 units on a scale
Standard Deviation 3.7
|
2.5 units on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 months post-strokeRange = 0 - 56 The Berg Balance Score assesses balance in sitting, standing, reaching, shifting weight and turning, with 0 defined as inability to balance and 56 defined as the ability to balance independently and without difficulty while performing each task.
Outcome measures
| Measure |
Early Locomotor Training Program
n=139 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
|
Late Locomotor Training Program
n=143 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
|
Home Exercise Program
n=126 Participants
HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
|
|---|---|---|---|
|
Berg Balance Score
Baseline
|
35.0 units on a scale
Standard Deviation 14.4
|
35.9 units on a scale
Standard Deviation 14.1
|
36.5 units on a scale
Standard Deviation 13.6
|
|
Berg Balance Score
6-month change from Baseline
|
8.8 units on a scale
Standard Deviation 8.1
|
5.3 units on a scale
Standard Deviation 7.0
|
7.9 units on a scale
Standard Deviation 8.5
|
|
Berg Balance Score
12-month change from Baseline
|
8.0 units on a scale
Standard Deviation 7.8
|
5.9 units on a scale
Standard Deviation 9.1
|
8.3 units on a scale
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 months post-strokeRange = 0 - 100 The ABC scale is a self reported measure of confidence with activities such as walking around the house, standing on a chair to reach or getting out of a car without losing balance or becoming unsteady. A score of 0 indicates no confidence that the activities can be performed without losing balance and a score 100 indicates confidence that the activities can be accomplished without losing balance.
Outcome measures
| Measure |
Early Locomotor Training Program
n=139 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
|
Late Locomotor Training Program
n=143 Participants
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
|
Home Exercise Program
n=126 Participants
HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
|
|---|---|---|---|
|
Activities Specific Balance Confidence (ABC) Score
Baseline
|
43.6 units on a scale
Standard Deviation 23.5
|
47.0 units on a scale
Standard Deviation 25.4
|
44.5 units on a scale
Standard Deviation 22.6
|
|
Activities Specific Balance Confidence (ABC) Score
6-month change from Baseline
|
13.8 units on a scale
Standard Deviation 20.8
|
6.2 units on a scale
Standard Deviation 20.2
|
15.6 units on a scale
Standard Deviation 19.4
|
|
Activities Specific Balance Confidence (ABC) Score
12-month change from Baseline
|
11.2 units on a scale
Standard Deviation 22.3
|
11.7 units on a scale
Standard Deviation 22.1
|
13.9 units on a scale
Standard Deviation 21.7
|
Adverse Events
Early Locomotor Training Program
Serious events: 51 serious events
Other events: 100 other events
Deaths: 0 deaths
Late Locomotor Training Program
Serious events: 59 serious events
Other events: 101 other events
Deaths: 0 deaths
Home Exercise Program
Serious events: 39 serious events
Other events: 88 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Early Locomotor Training Program
n=139 participants at risk
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
|
Late Locomotor Training Program
n=143 participants at risk
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
|
Home Exercise Program
n=126 participants at risk
HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
|
|---|---|---|---|
|
Vascular disorders
Recurrent Stroke
|
4.3%
6/139 • Number of events 6 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
2.1%
3/143 • Number of events 3 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
0.79%
1/126 • Number of events 1 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
|
Cardiac disorders
Myocardial Infarction (MI)
|
0.00%
0/139 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
0.70%
1/143 • Number of events 1 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
0.79%
1/126 • Number of events 1 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
5.8%
8/139 • Number of events 9 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
5.6%
8/143 • Number of events 8 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
4.0%
5/126 • Number of events 7 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
|
General disorders
Hospitalization
|
32.4%
45/139 • Number of events 64 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
37.1%
53/143 • Number of events 83 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
24.6%
31/126 • Number of events 48 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
|
General disorders
Limitation in activities of daily living (ADL)>48hrs
|
0.72%
1/139 • Number of events 1 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
1.4%
2/143 • Number of events 2 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
3.2%
4/126 • Number of events 4 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
|
General disorders
Other
|
0.72%
1/139 • Number of events 1 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
0.70%
1/143 • Number of events 1 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
3.2%
4/126 • Number of events 4 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
|
General disorders
Death
|
2.2%
3/139 • Number of events 3 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
2.8%
4/143 • Number of events 4 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
4.8%
6/126 • Number of events 6 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
Other adverse events
| Measure |
Early Locomotor Training Program
n=139 participants at risk
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
|
Late Locomotor Training Program
n=143 participants at risk
Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
|
Home Exercise Program
n=126 participants at risk
HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
|
|---|---|---|---|
|
General disorders
Minor fall, no or minimal injury
|
54.7%
76/139 • Number of events 181 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
53.8%
77/143 • Number of events 160 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
59.5%
75/126 • Number of events 150 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
|
Skin and subcutaneous tissue disorders
Open sore or blister, cuts
|
5.8%
8/139 • Number of events 9 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
6.3%
9/143 • Number of events 10 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
8.7%
11/126 • Number of events 12 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.72%
1/139 • Number of events 1 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
0.70%
1/143 • Number of events 1 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
0.00%
0/126 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
|
Musculoskeletal and connective tissue disorders
Muscle soreness or pain that persists for more than 48 hours
|
5.0%
7/139 • Number of events 7 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
8.4%
12/143 • Number of events 12 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
7.9%
10/126 • Number of events 10 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
|
General disorders
Dizziness/Fainting
|
7.9%
11/139 • Number of events 11 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
5.6%
8/143 • Number of events 9 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
0.00%
0/126 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphoretic
|
0.72%
1/139 • Number of events 1 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
1.4%
2/143 • Number of events 3 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
0.00%
0/126 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
|
Cardiac disorders
Excessive hypertension during exercise that requires the intervention to be stopped for the day
|
3.6%
5/139 • Number of events 6 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
5.6%
8/143 • Number of events 8 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
7.9%
10/126 • Number of events 11 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
|
Cardiac disorders
Low blood pressure during exercise that requires intervention to be stopped for the day
|
5.8%
8/139 • Number of events 11 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
4.9%
7/143 • Number of events 7 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
1.6%
2/126 • Number of events 3 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
|
Vascular disorders
DVT
|
0.00%
0/139 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
0.00%
0/143 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
0.79%
1/126 • Number of events 1 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
|
General disorders
Other
|
30.2%
42/139 • Number of events 59 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
32.9%
47/143 • Number of events 89 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
22.2%
28/126 • Number of events 48 • Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place