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

Phase 1

Completed

• Conditions: Healthy, Young Adults
• Interventions: Behavioral: RLIC; Behavioral: Sham conditioning; Behavioral: Muscle strength training; Behavioral: Driving training; Behavioral: Balance training

• Registration Number: NCT03512028
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-11-08
• Study First Submitted: 2018-04-16
• Study First Submitted QC: 2018-04-27
• Study First Posted: 2018-04-30
• Primary Completion: 2018-12-31
• Study Completion: 2019-01-31
• Results First Submitted: 2019-12-30
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-22
• Last Update Submitted: 2020-01-22
• Results First Posted: 2020-02-05
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote Limb Ischemic Conditioning (RLIC)	Balance training	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.
Remote Limb Ischemic Conditioning (RLIC)	Driving training	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.
Remote Limb Ischemic Conditioning (RLIC)	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.
Remote Limb Ischemic Conditioning (RLIC)	Muscle strength training	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	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	Driving training	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	Balance training	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	Muscle strength training	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.

Primary Outcome Measures

Name	Time	Method
One-repetition Maximum of Wrist Extensors	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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States