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

Primary Purpose

Healthy, Young Adults

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

RLIC

Sham conditioning

Muscle strength training

Driving training

Balance training

About this trial

This is an interventional treatment trial for Healthy, Young Adults focused on measuring ischemic conditioning, motor learning, strength, cognition

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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
Recent wrist, hand or forearm injury that would currently prevent ability to lift weights
History of lower extremity condition, injury, or surgery that would currently impair ability to stand or balance
Any extremity soft tissue, orthopedic, or vascular injury (i.e. peripheral vascular disease) which may contraindicate RLIC
Any cognitive, sensory, or communication problem that would prevent completion of the study
History of or current sleep apnea
Current intensive weight lifting or interval training exercise
Current substance abuse or dependence
Unwillingness to travel for all study visits

Sites / Locations

Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Remote Limb Ischemic Conditioning (RLIC)

Sham Conditioning

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

One-repetition Maximum of Wrist Extensors

The maximum amount of force (lbs) that a participant can generate while performing one wrist extension movement.

Secondary Outcome Measures

Full Information

NCT ID

NCT03512028

First Posted

April 16, 2018

Last Updated

January 22, 2020

Sponsor

Washington University School of Medicine

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

1. Study Identification

Unique Protocol Identification Number

NCT03512028

Brief Title

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

Official Title

Effects of Remote Limb Ischemic Conditioning to Enhance Performance, Cognitive-motor Learning and Muscle Strength in Healthy Young Adults

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

November 8, 2017 (Actual)

Primary Completion Date

December 31, 2018 (Actual)

Study Completion Date

January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Washington University School of Medicine

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Young Adults

Keywords

ischemic conditioning, motor learning, strength, cognition

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Single blinded, randomized controlled trial

Masking

Participant

Masking Description

Participants are masked to group assignment (RLIC vs. Sham conditioning).

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Remote Limb Ischemic Conditioning (RLIC)

Arm Type

Experimental

Arm Description

Arm Title

Sham Conditioning

Arm Type

Sham Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

RLIC

Other Intervention Name(s)

remote limb ischemic conditioning

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Sham conditioning

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Muscle strength training

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Driving training

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Balance training

Intervention Description

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 Measure Information:

Title

One-repetition Maximum of Wrist Extensors

Description

The maximum amount of force (lbs) that a participant can generate while performing one wrist extension movement.

Time Frame

Pre-intervention, post-intervention (2 weeks later), and 1 month post-intervention follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy adults between the age of 18 and 40 years Visual acuity of 20/20 with corrected vision Exclusion Criteria: 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 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 Recent wrist, hand or forearm injury that would currently prevent ability to lift weights History of lower extremity condition, injury, or surgery that would currently impair ability to stand or balance Any extremity soft tissue, orthopedic, or vascular injury (i.e. peripheral vascular disease) which may contraindicate RLIC Any cognitive, sensory, or communication problem that would prevent completion of the study History of or current sleep apnea Current intensive weight lifting or interval training exercise Current substance abuse or dependence Unwillingness to travel for all study visits

Facility Information:

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63108

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

After completion of the study, all of the individual participant data after deidentification will be submitted to Washington University data repository.

IPD Sharing Time Frame

Following publication of results. No ending date

IPD Sharing Access Criteria

Data will be available to anyone who wishes to access it through Washington University data repository.

IPD Sharing URL

https://openscholarship.wustl.edu

Learn more about this trial

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

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