Trial Outcomes & Findings for Effect of Number of Remote Limb Ischemic Conditioning Cycles on Learning Enhancement (NCT NCT03512041)

NCT ID: NCT03512041

Last Updated: 2019-08-26

Results Overview

The change from Visit 1 to Visit 7 in the average amount of time in seconds that a participant maintains the stability platform within ±3° of horizontal position during 5 trials of 30 seconds each. A greater increase in the balance score means more learning has occurred over the course of the study.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

40 participants

Primary outcome timeframe

Visit 1 and Visit 7, approximately 1 week

Results posted on

2019-08-26

Participant Flow

Participant milestones

Participant milestones
Measure
RLIC - 5 Cycles
Remote Limb Ischemic Conditioning (RLIC) is achieved via blood pressure cuff inflation on the non-dominant arm. 5 Cycles of RLIC requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7. RLIC - 5 cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays. Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7. Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7. Sequence production training: All participants underg
RLIC - 4 Cycles
RLIC is achieved via blood pressure cuff inflation on the non-dominant arm. 4 Cycles of RLIC requires 35 minutes and involves 4 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7. RLIC - 4 Cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays. Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7. Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7. Sequence production training: All participants undergo training on a discrete sequence pr
RLIC - 3 Cycles
RLIC is achieved via blood pressure cuff inflation on the non-dominant arm. 3 Cycles of RLIC requires 25 minutes and involves 3 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7. RLIC - 3 Cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays. Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7. Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7. Sequence production training: All participants undergo training on a discrete sequence pr
Sham Conditioning
Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the non-dominant arm. Sham conditioning requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. Sham conditioning is performed on visits 1-7. Sham conditioning: Sham conditioning is achieved as listed in the arm/group descriptions. Sham conditioning is performed on visits 1-7, which occur on consecutive weekdays. Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7. Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7. Sequence production training: All
Overall Study
STARTED
10
10
11
9
Overall Study
COMPLETED
10
10
11
9
Overall Study
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Number of Remote Limb Ischemic Conditioning Cycles on Learning Enhancement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
RLIC - 5 Cycles
n=10 Participants
Remote Limb Ischemic Conditioning (RLIC) is achieved via blood pressure cuff inflation on the non-dominant arm. 5 Cycles of RLIC requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7. RLIC - 5 cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays. Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7. Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7. Sequence production training: All participants underg
RLIC - 4 Cycles
n=10 Participants
RLIC is achieved via blood pressure cuff inflation on the non-dominant arm. 4 Cycles of RLIC requires 35 minutes and involves 4 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7. RLIC - 4 Cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays. Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7. Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7. Sequence production training: All participants undergo training on a discrete sequence pr
RLIC - 3 Cycles
n=11 Participants
RLIC is achieved via blood pressure cuff inflation on the non-dominant arm. 3 Cycles of RLIC requires 25 minutes and involves 3 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7. RLIC - 3 Cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays. Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7. Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7. Sequence production training: All participants undergo training on a discrete sequence pr
Sham Conditioning
n=9 Participants
Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the non-dominant arm. Sham conditioning requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. Sham conditioning is performed on visits 1-7. Sham conditioning: Sham conditioning is achieved as listed in the arm/group descriptions. Sham conditioning is performed on visits 1-7, which occur on consecutive weekdays. Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7. Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7. Sequence production training: All
Total
n=40 Participants
Total of all reporting groups
Age, Continuous
25.5 years
STANDARD_DEVIATION 3.9 • n=5 Participants
25.9 years
STANDARD_DEVIATION 2.9 • n=7 Participants
26.2 years
STANDARD_DEVIATION 4.6 • n=5 Participants
26.1 years
STANDARD_DEVIATION 1.6 • n=4 Participants
25.9 years
STANDARD_DEVIATION 3.2 • n=21 Participants
Sex: Female, Male
Female
7 Participants
n=5 Participants
7 Participants
n=7 Participants
6 Participants
n=5 Participants
8 Participants
n=4 Participants
28 Participants
n=21 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
3 Participants
n=7 Participants
5 Participants
n=5 Participants
1 Participants
n=4 Participants
12 Participants
n=21 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Asian
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
3 Participants
n=4 Participants
9 Participants
n=21 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
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
1 Participants
n=4 Participants
7 Participants
n=21 Participants
Race (NIH/OMB)
White
6 Participants
n=5 Participants
7 Participants
n=7 Participants
6 Participants
n=5 Participants
5 Participants
n=4 Participants
24 Participants
n=21 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (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
0 Participants
n=21 Participants
Region of Enrollment
United States
10 participants
n=5 Participants
10 participants
n=7 Participants
11 participants
n=5 Participants
9 participants
n=4 Participants
40 participants
n=21 Participants
Body Mass Index
24.1 kg/m*m
STANDARD_DEVIATION 6.6 • n=5 Participants
23.9 kg/m*m
STANDARD_DEVIATION 4.3 • n=7 Participants
26.7 kg/m*m
STANDARD_DEVIATION 5.3 • n=5 Participants
27.2 kg/m*m
STANDARD_DEVIATION 8.1 • n=4 Participants
25.5 kg/m*m
STANDARD_DEVIATION 6.1 • n=21 Participants
Resting systolic blood pressure
113 mmHg
STANDARD_DEVIATION 14 • n=5 Participants
116 mmHg
STANDARD_DEVIATION 14 • n=7 Participants
117 mmHg
STANDARD_DEVIATION 11 • n=5 Participants
116 mmHg
STANDARD_DEVIATION 12 • n=4 Participants
116 mmHg
STANDARD_DEVIATION 13 • n=21 Participants
Resting diastolic blood pressure
73 mmHg
STANDARD_DEVIATION 10 • n=5 Participants
74 mmHg
STANDARD_DEVIATION 10 • n=7 Participants
75 mmHg
STANDARD_DEVIATION 8 • n=5 Participants
74 mmHg
STANDARD_DEVIATION 8 • n=4 Participants
74 mmHg
STANDARD_DEVIATION 9 • n=21 Participants

PRIMARY outcome

Timeframe: Visit 1 and Visit 7, approximately 1 week

The change from Visit 1 to Visit 7 in the average amount of time in seconds that a participant maintains the stability platform within ±3° of horizontal position during 5 trials of 30 seconds each. A greater increase in the balance score means more learning has occurred over the course of the study.

Outcome measures

Outcome measures
Measure
RLIC - 5 Cycles
n=10 Participants
Remote Limb Ischemic Conditioning (RLIC) is achieved via blood pressure cuff inflation on the non-dominant arm. 5 Cycles of RLIC requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7. RLIC - 5 cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays. Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7. Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7. Sequence production training: All participants underg
RLIC - 4 Cycles
n=10 Participants
RLIC is achieved via blood pressure cuff inflation on the non-dominant arm. 4 Cycles of RLIC requires 35 minutes and involves 4 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7. RLIC - 4 Cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays. Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7. Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7. Sequence production training: All participants undergo training on a discrete sequence pr
RLIC - 3 Cycles
n=11 Participants
RLIC is achieved via blood pressure cuff inflation on the non-dominant arm. 3 Cycles of RLIC requires 25 minutes and involves 3 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7. RLIC - 3 Cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays. Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7. Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7. Sequence production training: All participants undergo training on a discrete sequence pr
Sham Conditioning
n=9 Participants
Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the non-dominant arm. Sham conditioning requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. Sham conditioning is performed on visits 1-7. Sham conditioning: Sham conditioning is achieved as listed in the arm/group descriptions. Sham conditioning is performed on visits 1-7, which occur on consecutive weekdays. Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7. Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7. Sequence production training: All
Balance Score
9.9 seconds
Standard Deviation 4.6
11.5 seconds
Standard Deviation 5.7
7.0 seconds
Standard Deviation 5.1
11.3 seconds
Standard Deviation 4.6

PRIMARY outcome

Timeframe: Visit 1 and Visit 7, approximately 1 week

The change from Visit 1 to Visit 7 in the average amount of time in seconds that a participant takes to stack and unstack pre-determined patterns of cups. A greater decrease in the cup stacking score means more learning has occurred over the course of the study.

Outcome measures

Outcome measures
Measure
RLIC - 5 Cycles
n=10 Participants
Remote Limb Ischemic Conditioning (RLIC) is achieved via blood pressure cuff inflation on the non-dominant arm. 5 Cycles of RLIC requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7. RLIC - 5 cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays. Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7. Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7. Sequence production training: All participants underg
RLIC - 4 Cycles
n=10 Participants
RLIC is achieved via blood pressure cuff inflation on the non-dominant arm. 4 Cycles of RLIC requires 35 minutes and involves 4 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7. RLIC - 4 Cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays. Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7. Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7. Sequence production training: All participants undergo training on a discrete sequence pr
RLIC - 3 Cycles
n=11 Participants
RLIC is achieved via blood pressure cuff inflation on the non-dominant arm. 3 Cycles of RLIC requires 25 minutes and involves 3 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7. RLIC - 3 Cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays. Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7. Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7. Sequence production training: All participants undergo training on a discrete sequence pr
Sham Conditioning
n=9 Participants
Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the non-dominant arm. Sham conditioning requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. Sham conditioning is performed on visits 1-7. Sham conditioning: Sham conditioning is achieved as listed in the arm/group descriptions. Sham conditioning is performed on visits 1-7, which occur on consecutive weekdays. Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7. Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7. Sequence production training: All
Cup Stacking Score
-22.2 seconds
Standard Deviation 8.8
-14.9 seconds
Standard Deviation 3.5
-11.9 seconds
Standard Deviation 10.4
-10.1 seconds
Standard Deviation 14.8

PRIMARY outcome

Timeframe: Visit 1 and Visit 7, approximately 1 week

The change from Visit 1 to Visit 7 in the average amount of time in seconds that a participant takes to complete pre-determined patterns of keypresses. A greater decrease in the Discrete Sequence Production Task score means more learning has occurred over the course of the study.

Outcome measures

Outcome measures
Measure
RLIC - 5 Cycles
n=10 Participants
Remote Limb Ischemic Conditioning (RLIC) is achieved via blood pressure cuff inflation on the non-dominant arm. 5 Cycles of RLIC requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7. RLIC - 5 cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays. Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7. Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7. Sequence production training: All participants underg
RLIC - 4 Cycles
n=10 Participants
RLIC is achieved via blood pressure cuff inflation on the non-dominant arm. 4 Cycles of RLIC requires 35 minutes and involves 4 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7. RLIC - 4 Cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays. Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7. Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7. Sequence production training: All participants undergo training on a discrete sequence pr
RLIC - 3 Cycles
n=11 Participants
RLIC is achieved via blood pressure cuff inflation on the non-dominant arm. 3 Cycles of RLIC requires 25 minutes and involves 3 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7. RLIC - 3 Cycles: RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays. Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7. Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7. Sequence production training: All participants undergo training on a discrete sequence pr
Sham Conditioning
n=9 Participants
Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the non-dominant arm. Sham conditioning requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. Sham conditioning is performed on visits 1-7. Sham conditioning: Sham conditioning is achieved as listed in the arm/group descriptions. Sham conditioning is performed on visits 1-7, which occur on consecutive weekdays. Balance training: All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7. Arm training: All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7. Sequence production training: All
Discrete Sequence Production Task Score
-3.1 seconds
Standard Deviation 0.7
-2.9 seconds
Standard Deviation 0.3
-2.6 seconds
Standard Deviation 0.6
-2.9 seconds
Standard Deviation 0.3

Adverse Events

RLIC - 5 Cycles

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

RLIC - 4 Cycles

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

RLIC - 3 Cycles

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sham Conditioning

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Catherine E Lang

Washington University School of Medicine

Phone: 314-286-1945

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place