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Completed

NCT Number: NCT03512028

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

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.

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Key information

Conditions

Healthy, Young Adults

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: remote limb ischemic conditioning

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.

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

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.

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.

Primary outcomes

  1. One-repetition Maximum of Wrist Extensors

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

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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 30, 2018
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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