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

The Washington University

Status and phase: Completed; Phase 1

Conditions: Healthy, Young Adults

Treatments: Behavioral: Balance training; Behavioral: Sham conditioning; Behavioral: Muscle strength training; Behavioral: Driving training; Behavioral: RLIC

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03512028

NIHR01HD085930-Aim1

R01HD085930 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

Remote Limb Ischemic Conditioning (RLIC)

Experimental group

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.

Treatment:

Behavioral: RLIC

Behavioral: Driving training

Behavioral: Muscle strength training

Behavioral: Balance training

Sham Conditioning

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Driving training

Behavioral: Muscle strength training

Behavioral: Balance training

Behavioral: Sham conditioning