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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD085930 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The purpose of this research study is to determine if remote limb ischemic conditioning (RLIC) can enhance learning of a motor (balance) and an ecologically valid, complex cognitive-motor (driving) task, and increase skeletal muscle strength in neurologically-intact young adults.
Ischemic conditioning is an endogenous phenomenon in which exposing a target organ or tissue to one or more brief episodes of ischemia results in protection of that organ against subsequent ischemia. The effects of ischemic conditioning are not confined within an organ but can be can be transferred from one organ to another, a technique called remote ischemic conditioning. A clinically feasible method for this is remote limb ischemic conditioning (RLIC), where episodes of ischemia and perfusion are induced with a blood pressure cuff placed on the arm.
The overall goal of this line of work is to use ischemic conditioning to enhance learning and outcomes in persons with neurologic injuries. Two previous studies have shown that remote limb ischemic conditioning (RLIC) can enhance learning a motor task in healthy young adults. The current study extends that work to determine if RLIC enhances muscle strength training and a complex cognitive-motor task (simulated driving). This Phase I study will yield the necessary information to design and execute subsequent trials in neurologic patient populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Limb Ischemic Conditioning (RLIC) | Experimental | RLIC is achieved via blood pressure cuff inflation to 20 mmHg above systolic blood pressure on the dominant arm. 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 1-8. |
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| Sham Conditioning | Sham Comparator | Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the 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 1-8. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RLIC | Behavioral | See descriptions under arm/group descriptions. RLIC is delivered for 8 visits. Visits 1-3 occur on consecutive work days and visits 4-8 occur on alternating week days. |
| Measure | Description | Time Frame |
|---|---|---|
| One-repetition Maximum of Wrist Extensors | The maximum amount of force (lbs) that a participant can generate while performing one wrist extension movement. | Pre-intervention, post-intervention (2 weeks later), and 1 month post-intervention follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63108 | United States |
After completion of the study, all of the individual participant data after deidentification will be submitted to Washington University data repository.
Following publication of results. No ending date
Data will be available to anyone who wishes to access it through Washington University data repository.
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| ID | Title | Description |
|---|---|---|
| FG000 | Remote Limb Ischemic Conditioning (RLIC) | RLIC is achieved via blood pressure cuff inflation to 20 mmHg above systolic blood pressure on the dominant arm. 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 1-8. RLIC is delivered for 8 visits. Visits 1-3 occur on consecutive work days and visits 4-8 occur on alternating week days. Muscle strength training: All participants undergo muscle strength training of the wrist extensor muscles on one side. Strength training follows standard American College of Sports Medicine guidelines for frequency, intensity, progression etc. Strength training is provided at visits 3-8 |
| FG001 | Sham Conditioning | Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the 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 1-8. Sham conditioning is delivered for 8 visits. Visits 1-3 occur on consecutive work days and visits 4-8 occur on alternating week days. Muscle strength training: All participants undergo muscle strength training of the wrist extensor muscles on one side. Strength training follows standard American College of Sports Medicine guidelines for frequency, intensity, progression etc. Strength training is provided at visits 3-8 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Remote Limb Ischemic Conditioning (RLIC) | RLIC is achieved via blood pressure cuff inflation to 20 mmHg above systolic blood pressure on the dominant arm. 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 1-8. RLIC is delivered for 8 visits. Visits 1-3 occur on consecutive work days and visits 4-8 occur on alternating week days. Muscle strength training: All participants undergo muscle strength training of the wrist extensor muscles on one side. Strength training follows standard American College of Sports Medicine guidelines for frequency, intensity, progression etc. Strength training is provided at visits 3-8 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | One-repetition Maximum of Wrist Extensors | The maximum amount of force (lbs) that a participant can generate while performing one wrist extension movement. | Posted | Mean | Standard Deviation | lbs | Pre-intervention, post-intervention (2 weeks later), and 1 month post-intervention follow-up |
|
Duration of the intervention, which was two weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Remote Limb Ischemic Conditioning (RLIC) | RLIC is achieved via blood pressure cuff inflation to 20 mmHg above systolic blood pressure on the dominant arm. 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 1-8. RLIC is delivered for 8 visits. Visits 1-3 occur on consecutive work days and visits 4-8 occur on alternating week days. Muscle strength training: All participants undergo muscle strength training of the wrist extensor muscles on one side. Strength training follows standard American College of Sports Medicine guidelines for frequency, intensity, progression etc. Strength training is provided at visits 3-8 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine Lang | Washington University School of Medicine | 314-286-1945 | langc@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 14, 2017 | Dec 30, 2019 | Prot_SAP_000.pdf |
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Single blinded, randomized controlled trial
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Participants are masked to group assignment (RLIC vs. Sham conditioning).
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| Sham conditioning | Behavioral | See descriptions under arm/group descriptions. Sham conditioning is delivered for 8 visits. Visits 1-3 occur on consecutive work days and visits 4-8 occur on alternating week days. |
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| Muscle strength training | Behavioral | All participants undergo muscle strength training of the wrist extensor muscles on one side. Strength training follows standard American College of Sports Medicine guidelines for frequency, intensity, progression etc. Strength training is provided at visits 3-8 |
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| Driving training | Behavioral | All participants undergo training of a complex cognitive-motor task using a driving simulator. Participants learn to 'drive' on a virtual course, maximizing speed and minimizing errors. Participants perform the driving task once each day for visits 3-8. |
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| Balance training | Behavioral | 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 3-8. |
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| BG001 | Sham Conditioning | Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the 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 1-8. Sham conditioning is delivered for 8 visits. Visits 1-3 occur on consecutive work days and visits 4-8 occur on alternating week days. Muscle strength training: All participants undergo muscle strength training of the wrist extensor muscles on one side. Strength training follows standard American College of Sports Medicine guidelines for frequency, intensity, progression etc. Strength training is provided at visits 3-8 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m*m |
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| OG001 | Sham Conditioning | Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the 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 1-8. Sham conditioning is delivered for 8 visits. Visits 1-3 occur on consecutive work days and visits 4-8 occur on alternating week days. Muscle strength training: All participants undergo muscle strength training of the wrist extensor muscles on one side. Strength training follows standard American College of Sports Medicine guidelines for frequency, intensity, progression etc. Strength training is provided at visits 3-8 |
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| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Sham Conditioning | Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the 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 1-8. Sham conditioning is delivered for 8 visits. Visits 1-3 occur on consecutive work days and visits 4-8 occur on alternating week days. Muscle strength training: All participants undergo muscle strength training of the wrist extensor muscles on one side. Strength training follows standard American College of Sports Medicine guidelines for frequency, intensity, progression etc. Strength training is provided at visits 3-8 | 0 | 15 | 0 | 15 | 0 | 15 |
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