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Trial record 7 of 9 for:    driving | NICHD | NIH

Remote Limb Ischemic Conditioning to Enhance Learning and Muscle Strength in Healthy Young Adults

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ClinicalTrials.gov Identifier: NCT03512028
Recruitment Status : Recruiting
First Posted : April 30, 2018
Last Update Posted : June 19, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Catherine E. Lang, Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy, Young Adults Behavioral: RLIC Behavioral: Sham conditioning Behavioral: Muscle strength training Behavioral: Driving training Behavioral: Balance training Phase 1

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single blinded, randomized controlled trial
Masking: Single (Participant)
Masking Description: Participants are masked to group assignment (RLIC vs. Sham conditioning).
Primary Purpose: Treatment
Official Title: Effects of Remote Limb Ischemic Conditioning to Enhance Performance, Cognitive-motor Learning and Muscle Strength in Healthy Young Adults
Actual Study Start Date : November 8, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : July 31, 2019

Arm Intervention/treatment
Experimental: 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.
Behavioral: RLIC
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.
Other Name: remote limb ischemic conditioning

Behavioral: 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

Behavioral: Driving training
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.

Behavioral: 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 3-8.

Sham Comparator: 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.
Behavioral: Sham conditioning
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.

Behavioral: 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

Behavioral: Driving training
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.

Behavioral: 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 3-8.




Primary Outcome Measures :
  1. One-repetition maximum of wrist extensors [ Time Frame: Within 7 weeks ]
    The maximum amount of force (kg) that a participant can generate while performing one wrist extension movement.

  2. Driving simulator score [ Time Frame: Within 7 weeks ]
    A composite score of time x errors, where time (seconds) = time to completion of entire driving task, and errors= graded penalty for hitting a pedestrian, collisions, center lane crossing, off road accidents, stop sign and traffic light rule violations, and other driving errors.

  3. Balance score [ Time Frame: Within 7 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adults between the age of 18 and 40 years
  2. Visual acuity of 20/20 with corrected vision

Exclusion Criteria:

  1. History of neurological condition (i.e. stroke, Alzheimer's disease, Parkinson's disease), Attention Deficit Hyperactivity Disorder (ADHD), depression, bipolar disorder, balance impairment, or vestibular disorder
  2. History of severe motion sickness, moderate to severe motion sickness or nausea on oculo-motor components of Simulator sickness questionnaire, inability to ride a car, boat, train or airplane due to motion sickness
  3. Recent wrist, hand or forearm injury that would currently prevent ability to lift weights
  4. History of lower extremity condition, injury, or surgery that would currently impair ability to stand or balance
  5. Any extremity soft tissue, orthopedic, or vascular injury (i.e. peripheral vascular disease) which may contraindicate RLIC
  6. Any cognitive, sensory, or communication problem that would prevent completion of the study
  7. History of or current sleep apnea
  8. Current intensive weight lifting or interval training exercise
  9. Current substance abuse or dependence
  10. Unwillingness to travel for all study visits

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512028


Contacts
Contact: Catherine Lang, PT, PhD 314-286-1945 langc@wustl.edu
Contact: Swati Surkar, PT, PhD 314-633-8450 ssurkar@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63108
Contact: Catherine Lang, PT, PhD    314-286-1945    langc@wustl.edu   
Contact: Maggie Bland, DPT, MSCI    314-633-8450    blandm@wustl.edu   
Principal Investigator: Catherine E Lang, PhD         
Sponsors and Collaborators
Washington University School of Medicine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Responsible Party: Catherine E. Lang, Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03512028     History of Changes
Other Study ID Numbers: NIHR01HD085930-Aim1
R01HD085930 ( U.S. NIH Grant/Contract )
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After completion of the study, all of the individual participant data after deidentification will be submitted to Washington University data repository.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Following publication of results. No ending date
Access Criteria: Data will be available to anyone who wishes to access it through Washington University data repository.
URL: https://openscholarship.wustl.edu

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Catherine E. Lang, Washington University School of Medicine:
ischemic conditioning, motor learning, strength, cognition