Trial Outcomes & Findings for Fatiguing Arm Exercise Following Stroke (NCT NCT03194464)
NCT ID: NCT03194464
Last Updated: 2020-06-04
Results Overview
SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using transcranial magnetic stimulation (TMS) measured here in the ipsilesional hemisphere (IH) at each point to determine how it is modulated in response to task-failure. SICI is quantified as a ratio where values \<1 reflect inhibition and \>1 disinhibition or relative excitation. In health, SICI is \~0.5. Thus if SICI = 0.8, while \<1 it would indicate less inhibition than expected in health. Transient change in SICI from 0.8 to 1.1 over the course of this experimental paradigm would reflect a period of relative excitation in response to the exercise paradigm.
COMPLETED
NA
15 participants
baseline, post task-failure (minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)
2020-06-04
Participant Flow
Participants identified by the VA Brain Rehabilitation Research Center (BRRC) screening and recruitment core enrolled between 2/1/2016 - 5/21/2018.
Participant milestones
| Measure |
Task-Failure, Extended Session
individuals with upper-extremity impairment resulting from stroke, enrolled six or more months following stroke performed submaximal exercise (grip): participants performed submaximal gripping with the non-paretic hand to task failure, guided by visual feedback. Recovery was monitored for an extended period of 3:45 following task-failure.
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|---|---|
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Overall Study
STARTED
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15
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Overall Study
COMPLETED
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13
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Task-Failure, Extended Session
individuals with upper-extremity impairment resulting from stroke, enrolled six or more months following stroke performed submaximal exercise (grip): participants performed submaximal gripping with the non-paretic hand to task failure, guided by visual feedback. Recovery was monitored for an extended period of 3:45 following task-failure.
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Overall Study
data not usable
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2
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Baseline Characteristics
Fatiguing Arm Exercise Following Stroke
Baseline characteristics by cohort
| Measure |
Task-failure, Extended Session
n=13 Participants
Exercise to fatigue followed by repeated monitoring of recovery until 3:45 after.
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|---|---|
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Age, Continuous
Extended Session
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61.1 years
STANDARD_DEVIATION 8.2 • n=5 Participants
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Sex: Female, Male
Female
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2 Participants
n=5 Participants
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Sex: Female, Male
Male
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11 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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13 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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4 Participants
n=5 Participants
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Race (NIH/OMB)
White
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9 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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13 participants
n=5 Participants
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Upper-extremity Fugl-Meyer Motor Assessment
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54.6 units on a scale
STANDARD_DEVIATION 13.2 • n=5 Participants
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Montreal Cognitive Assessment
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27.0 units on a scale
STANDARD_DEVIATION 1.96 • n=5 Participants
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Center for Epidemiologic Studies - Depression Scale
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9.0 units on a scale
STANDARD_DEVIATION 9.3 • n=5 Participants
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Fatigue Severity Scale
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3.95 units on a scale
STANDARD_DEVIATION 1.58 • n=5 Participants
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PRIMARY outcome
Timeframe: baseline, post task-failure (minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)Population: Only 13/15 data sets were usable for reasons explained elsewhere in the record. Thus, while 15 individuals were enrolled, we were able to analyze only 13 of these individuals' data.
SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using transcranial magnetic stimulation (TMS) measured here in the ipsilesional hemisphere (IH) at each point to determine how it is modulated in response to task-failure. SICI is quantified as a ratio where values \<1 reflect inhibition and \>1 disinhibition or relative excitation. In health, SICI is \~0.5. Thus if SICI = 0.8, while \<1 it would indicate less inhibition than expected in health. Transient change in SICI from 0.8 to 1.1 over the course of this experimental paradigm would reflect a period of relative excitation in response to the exercise paradigm.
Outcome measures
| Measure |
Task-Failure, Extended Session
n=13 Participants
individuals with upper-extremity impairment following stroke
submaximal exercise (grip): participants perform repeated gripping with visual feedback to task failure
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|---|---|
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Short Intracortical Inhibition (SICI)
Baseline
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0.83 SICI ratio
Standard Error 0.07
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Short Intracortical Inhibition (SICI)
0 min post-task-failure
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1.14 SICI ratio
Standard Error 0.15
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Short Intracortical Inhibition (SICI)
45 min post-task-failure
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0.89 SICI ratio
Standard Error 0.11
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Short Intracortical Inhibition (SICI)
90 min post-task-failure
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0.88 SICI ratio
Standard Error 0.05
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Short Intracortical Inhibition (SICI)
135 min post-task-failure
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0.82 SICI ratio
Standard Error 0.06
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Short Intracortical Inhibition (SICI)
180 min post-task-failure
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0.87 SICI ratio
Standard Error 0.06
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Short Intracortical Inhibition (SICI)
225 min post-task-failure
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0.81 SICI ratio
Standard Error 0.06
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PRIMARY outcome
Timeframe: Baseline, pre-exercise of 8 repeated sessionsPopulation: Only 10/12 data sets analyzed because it was possible to induce SICI in only 10 individuals.
SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using transcranial magnetic stimulation (TMS) measured here in the ipsilesional hemisphere (IH) at each point to determine how it is modulated in response to task-failure. SICI is quantified as a ratio where values \<1 reflect inhibition and \>1 disinhibition or relative excitation. In health, SICI is \~0.5. Thus if SICI = 0.8, while \<1 it would indicate less inhibition than expected in health. Transient change in SICI from 0.8 to 1.1 over the course of this experimental paradigm would reflect a period of relative excitation in response to the exercise paradigm.
Outcome measures
| Measure |
Task-Failure, Extended Session
n=10 Participants
individuals with upper-extremity impairment following stroke
submaximal exercise (grip): participants perform repeated gripping with visual feedback to task failure
|
|---|---|
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SICI Ratio
Session1
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0.89 SICI ratio
Standard Deviation 0.25
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SICI Ratio
Session2
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0.85 SICI ratio
Standard Deviation 0.14
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SICI Ratio
Session3
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0.93 SICI ratio
Standard Deviation 0.29
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SICI Ratio
Session4
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0.80 SICI ratio
Standard Deviation 0.29
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SICI Ratio
Session5
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0.78 SICI ratio
Standard Deviation 0.28
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SICI Ratio
Session6
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0.77 SICI ratio
Standard Deviation 0.37
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SICI Ratio
Session7
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0.88 SICI ratio
Standard Deviation 0.25
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SICI Ratio
Session8
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0.83 SICI ratio
Standard Deviation 0.31
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OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, post task-failure (requires variable timeline from minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)Population: The Box and Blocks test (BBT) is an accepted measure of motor function/dexterity. Score reflect the number of 1" blocks moved from one half of a divided box to the other in 1 minute. Higher numbers indicate better performance. Only 13/15 data sets were analyzed because other data sets were not usable.
The BBT measures motor function/dexterity, scored as the number of blocks transferred in 1 minute. Here function of the paretic hand was measured at each time point: baseline, post-task failure, 45min post, 90min post, 135min post, 180min post, 225min post-task failure to determine the change in paretic hand BBT performance following exercise to task-failure. Scores are numeric ranging from 0 (no blocks transferred) to whatever the participant is able to achieve. Healthy age-matched adults without motor disability score in the range of 60 (+/- 10) blocks transferred in 1 minute.
Outcome measures
| Measure |
Task-Failure, Extended Session
n=13 Participants
individuals with upper-extremity impairment following stroke
submaximal exercise (grip): participants perform repeated gripping with visual feedback to task failure
|
|---|---|
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Box and Blocks Test (BBT)
Baseline
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25.4 blocks
Standard Error 3.6
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Box and Blocks Test (BBT)
0 min post-task-failure
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25.5 blocks
Standard Error 3.2
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Box and Blocks Test (BBT)
45 min post-task-failure
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25.0 blocks
Standard Error 3.3
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Box and Blocks Test (BBT)
90 min post-task-failure
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26.1 blocks
Standard Error 3.4
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Box and Blocks Test (BBT)
135 min post-task-failure
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26.7 blocks
Standard Error 3.6
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Box and Blocks Test (BBT)
180 min post-task-failure
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25.7 blocks
Standard Error 3.6
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Box and Blocks Test (BBT)
225 min post-task-failure
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26.9 blocks
Standard Error 3.7
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OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, pre-exercise of 8 repeated sessionsPopulation: BBT data were obtained in all 12 individuals at each of 8 sessions.
The BBT measures motor function/dexterity, scored as the number of blocks transferred in 1 minute. Here function of the paretic hand was measured prior to exercise at each of 8 repeated sessions conducted twice weekly for 4 weeks to determine the change in paretic hand BBT performance following repeated sessions of exercise to task-failure. Scores are numeric ranging from 0 (no blocks transferred) to whatever the participant is able to achieve. Healthy age-matched adults without motor disability score in the range of 60 (+/- 10) blocks transferred in 1 minute.
Outcome measures
| Measure |
Task-Failure, Extended Session
n=12 Participants
individuals with upper-extremity impairment following stroke
submaximal exercise (grip): participants perform repeated gripping with visual feedback to task failure
|
|---|---|
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Box and Blocks Test (BBT)
Session1
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23.2 blocks
Standard Deviation 12.8
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Box and Blocks Test (BBT)
Session2
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23.5 blocks
Standard Deviation 13.2
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Box and Blocks Test (BBT)
Session3
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26.8 blocks
Standard Deviation 11.5
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Box and Blocks Test (BBT)
Session4
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28.5 blocks
Standard Deviation 11.9
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Box and Blocks Test (BBT)
Session5
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27.4 blocks
Standard Deviation 12.7
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Box and Blocks Test (BBT)
Session6
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29.8 blocks
Standard Deviation 10.9
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Box and Blocks Test (BBT)
Session7
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29.7 blocks
Standard Deviation 11.8
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Box and Blocks Test (BBT)
Session8
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29.3 blocks
Standard Deviation 11.9
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Adverse Events
Task-failure, Extended Session
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Carolynn Patten (Principal Investigator)
VA Northern California Health Care System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place