Trial Outcomes & Findings for Inflammatory Abnormalities in Muscle After Stroke: Effects of Exercise (NCT NCT00387712)
NCT ID: NCT00387712
Last Updated: 2017-09-14
Results Overview
Cardiovascular fitness is measured by collecting the expired gases during a progressive graded treadmill test.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
Baseline to 6 month
Results posted on
2017-09-14
Participant Flow
Veterans with chronic hemiparetic stroke (latency \> 6 months) were recruited from the Baltimore VA and University of Maryland Neurology and Primary care clinics, as well as through Institutional Review Board approved flyers and ads.
Reasons for participant exclusion were not meeting eligibility criteria, screen failures (ischemia on stress test or serious lab abnormalities) new medical conditions, study time requirements, return to work, lost to follow-up, lack of transportation.
Participant milestones
| Measure |
Velocity Based Treadmill Training
6-month treadmill exercise progressed on speed based on individual participant's tolerance, abilities and safety.
|
Duration Based Treadmill Training
6-month treadmill exercise at self-selected speed progressed only on training duration.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
52
|
|
Overall Study
COMPLETED
|
18
|
16
|
|
Overall Study
NOT COMPLETED
|
29
|
36
|
Reasons for withdrawal
| Measure |
Velocity Based Treadmill Training
6-month treadmill exercise progressed on speed based on individual participant's tolerance, abilities and safety.
|
Duration Based Treadmill Training
6-month treadmill exercise at self-selected speed progressed only on training duration.
|
|---|---|---|
|
Overall Study
Physician Decision
|
6
|
4
|
|
Overall Study
Lost to Follow-up
|
17
|
20
|
|
Overall Study
Withdrawal by Subject
|
6
|
12
|
Baseline Characteristics
Inflammatory Abnormalities in Muscle After Stroke: Effects of Exercise
Baseline characteristics by cohort
| Measure |
Velocity Based Treadmill Training
n=47 Participants
6-month treadmill exercise progressed only gait speed and then incline to achieve moderate aerobic exercise heart rate training goal.
|
Duration Based Treadmill Training
n=52 Participants
6-month treadmill exercise at self-selected speed progressed only on training duration.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
40 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 3 • n=5 Participants
|
64 years
STANDARD_DEVIATION 6 • n=7 Participants
|
63 years
STANDARD_DEVIATION 3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
28 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
52 participants
n=7 Participants
|
99 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthPopulation: Randomized study design with Intent to treat group by time analysis of change in peak cardiovascular fitness levels between the higher-intensity treadmill training group and the lower intensity training group across baseline to 6 months post-exercise time points.
Cardiovascular fitness is measured by collecting the expired gases during a progressive graded treadmill test.
Outcome measures
| Measure |
Velocity Based Treadmill Training
n=18 Participants
6-month treadmill exercise progressed only gait speed and then incline to achieve moderate aerobic exercise heart rate training goal.
|
Duration Based Treadmill Training
n=16 Participants
6-month treadmill exercise at self-selected speed progressed only on training duration.
|
|---|---|---|
|
Cardiovascular Fitness (VO2 Peak)
baseline
|
15.9 ml/kg/min
Standard Error 1.7
|
16.6 ml/kg/min
Standard Error 1.2
|
|
Cardiovascular Fitness (VO2 Peak)
6 month
|
21.3 ml/kg/min
Standard Error 1.6
|
17.5 ml/kg/min
Standard Error 1.2
|
PRIMARY outcome
Timeframe: Baseline to 6 monthPopulation: The difference muscle and participant number reflects those that participated and completed pre/post biopsies. Paretic thigh muscle, at baseline and after 6 month interventions, are analyzed for myosin heavy chain proportions. Values were the mean of duplicates run on polymerase chain reaction were normalized to a ribosomal protein mRNA.
Skeletal muscle punch biopsies are obtained from the bilateral (paretic and non-paretic) vastus lateralis thigh muscle, at baseline and after 6 month interventions. Homogenized muscle messenger ribonucleic acid (mRNA) for myosin heavy chain isoforms are analyzed by real time polymerase chain reaction as fluorescent units with normalization to an acidic ribosomal protein, a housekeeping gene.
Outcome measures
| Measure |
Velocity Based Treadmill Training
n=7 Participants
6-month treadmill exercise progressed only gait speed and then incline to achieve moderate aerobic exercise heart rate training goal.
|
Duration Based Treadmill Training
n=6 Participants
6-month treadmill exercise at self-selected speed progressed only on training duration.
|
|---|---|---|
|
Paretic Thigh Skeletal Muscle Myosin Heavy Chain Myosin Heavy Chain Isoform 2a
Baseline
|
3.35 PCR flourescence units
Standard Error 0.87
|
3.64 PCR flourescence units
Standard Error 0.74
|
|
Paretic Thigh Skeletal Muscle Myosin Heavy Chain Myosin Heavy Chain Isoform 2a
6 months
|
4.40 PCR flourescence units
Standard Error 0.71
|
5.44 PCR flourescence units
Standard Error 0.79
|
SECONDARY outcome
Timeframe: baseline to 6 monthPopulation: Randomized study design with intent to treat group by time analysis of change in floor walking time between the higher-intensity treadmill training group and the lower intensity training group across baseline to 6 months post-exercise time points.
Participants are instructed to walk fast as comfortable on a straight pathway on the floor demarcated by cones. They may use their usual canes, walkers, and orthotics while they walk. The walks are timed, the value is the mean of three trials with an interval rest between each trial.
Outcome measures
| Measure |
Velocity Based Treadmill Training
n=18 Participants
6-month treadmill exercise progressed only gait speed and then incline to achieve moderate aerobic exercise heart rate training goal.
|
Duration Based Treadmill Training
n=16 Participants
6-month treadmill exercise at self-selected speed progressed only on training duration.
|
|---|---|---|
|
30 Foot Walk Time (Sec)
baseline
|
15.4 sec
Standard Error 2.1
|
17.2 sec
Standard Error 2.2
|
|
30 Foot Walk Time (Sec)
6 month
|
13.8 sec
Standard Error 2.1
|
15.9 sec
Standard Error 1.9
|
Adverse Events
Velocity Based Treadmill Training
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Duration Based Treadmill Training
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Velocity Based Treadmill Training
n=47 participants at risk
6-month treadmill exercise progressed only gait speed and then incline to achieve moderate aerobic exercise heart rate training goal.
|
Duration Based Treadmill Training
n=52 participants at risk
6-month treadmill exercise at self-selected speed progressed only on training duration.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
2.1%
1/47 • Number of events 1 • Adverse event data was collected from time of consent signing to completion of the final post test (consent process, screening, baseline testing, 6 month intervention, and post testing. This represents about 7 to 8 months of participant study involvement.
Adverse and serious adverse event are the definition are similar to those used in clinical trials.gov.
|
0.00%
0/52 • Adverse event data was collected from time of consent signing to completion of the final post test (consent process, screening, baseline testing, 6 month intervention, and post testing. This represents about 7 to 8 months of participant study involvement.
Adverse and serious adverse event are the definition are similar to those used in clinical trials.gov.
|
|
Nervous system disorders
recurrent stroke
|
0.00%
0/47 • Adverse event data was collected from time of consent signing to completion of the final post test (consent process, screening, baseline testing, 6 month intervention, and post testing. This represents about 7 to 8 months of participant study involvement.
Adverse and serious adverse event are the definition are similar to those used in clinical trials.gov.
|
1.9%
1/52 • Number of events 1 • Adverse event data was collected from time of consent signing to completion of the final post test (consent process, screening, baseline testing, 6 month intervention, and post testing. This represents about 7 to 8 months of participant study involvement.
Adverse and serious adverse event are the definition are similar to those used in clinical trials.gov.
|
|
Infections and infestations
UTI
|
0.00%
0/47 • Adverse event data was collected from time of consent signing to completion of the final post test (consent process, screening, baseline testing, 6 month intervention, and post testing. This represents about 7 to 8 months of participant study involvement.
Adverse and serious adverse event are the definition are similar to those used in clinical trials.gov.
|
1.9%
1/52 • Number of events 1 • Adverse event data was collected from time of consent signing to completion of the final post test (consent process, screening, baseline testing, 6 month intervention, and post testing. This represents about 7 to 8 months of participant study involvement.
Adverse and serious adverse event are the definition are similar to those used in clinical trials.gov.
|
Other adverse events
| Measure |
Velocity Based Treadmill Training
n=47 participants at risk
6-month treadmill exercise progressed only gait speed and then incline to achieve moderate aerobic exercise heart rate training goal.
|
Duration Based Treadmill Training
n=52 participants at risk
6-month treadmill exercise at self-selected speed progressed only on training duration.
|
|---|---|---|
|
Cardiac disorders
Abnormal cardiac screening treadmill test
|
4.3%
2/47 • Number of events 2 • Adverse event data was collected from time of consent signing to completion of the final post test (consent process, screening, baseline testing, 6 month intervention, and post testing. This represents about 7 to 8 months of participant study involvement.
Adverse and serious adverse event are the definition are similar to those used in clinical trials.gov.
|
5.8%
3/52 • Number of events 3 • Adverse event data was collected from time of consent signing to completion of the final post test (consent process, screening, baseline testing, 6 month intervention, and post testing. This represents about 7 to 8 months of participant study involvement.
Adverse and serious adverse event are the definition are similar to those used in clinical trials.gov.
|
|
Metabolism and nutrition disorders
Screening lab abnormality
|
6.4%
3/47 • Number of events 3 • Adverse event data was collected from time of consent signing to completion of the final post test (consent process, screening, baseline testing, 6 month intervention, and post testing. This represents about 7 to 8 months of participant study involvement.
Adverse and serious adverse event are the definition are similar to those used in clinical trials.gov.
|
3.8%
2/52 • Number of events 2 • Adverse event data was collected from time of consent signing to completion of the final post test (consent process, screening, baseline testing, 6 month intervention, and post testing. This represents about 7 to 8 months of participant study involvement.
Adverse and serious adverse event are the definition are similar to those used in clinical trials.gov.
|
|
Musculoskeletal and connective tissue disorders
abnormal screening imaging
|
6.4%
3/47 • Number of events 3 • Adverse event data was collected from time of consent signing to completion of the final post test (consent process, screening, baseline testing, 6 month intervention, and post testing. This represents about 7 to 8 months of participant study involvement.
Adverse and serious adverse event are the definition are similar to those used in clinical trials.gov.
|
7.7%
4/52 • Number of events 4 • Adverse event data was collected from time of consent signing to completion of the final post test (consent process, screening, baseline testing, 6 month intervention, and post testing. This represents about 7 to 8 months of participant study involvement.
Adverse and serious adverse event are the definition are similar to those used in clinical trials.gov.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place