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

Healthy, Young Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03512028
• Other study ID #: NIHR01HD085930-Aim1
• Secondary ID: R01HD085930
• Status: Completed
• Phase: Phase 1
• Start date: November 8, 2017
• Est. completion date: January 31, 2019

Study information

• Verified date: January 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy, Young Adults
• Ischemia

Intervention

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.
• 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.
• 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
• 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.
• 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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	One-repetition Maximum of Wrist Extensors	The maximum amount of force (lbs) that a participant can generate while performing one wrist extension movement.	Pre-intervention, post-intervention (2 weeks later), and 1 month post-intervention follow-up