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

NCT03512028 | Completed Phase 1 Results DMC

• 2 other identifiers: NIHR01HD085930-Aim1R01HD085930
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy, Young Adults

Keywords

ischemic conditioning, motor learning, strength, cognition

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Remote Limb Ischemic Conditioning (RLIC)

EXPERIMENTAL

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.

Behavioral: RLIC; Behavioral: Muscle strength training; Behavioral: Driving training; Behavioral: Balance training

Sham Conditioning

SHAM COMPARATOR

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.

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

Interventions

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.

Also known as: remote limb ischemic conditioning

Remote Limb Ischemic Conditioning (RLIC)

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.

Sham Conditioning

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

Remote Limb Ischemic Conditioning (RLIC); Sham Conditioning

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.

Remote Limb Ischemic Conditioning (RLIC); Sham Conditioning

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.

Remote Limb Ischemic Conditioning (RLIC); Sham Conditioning

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Results Point of Contact

• Title: Catherine Lang
• Organization: Washington University School of Medicine

langc@wustl.edu

314-286-1945

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are masked to group assignment (RLIC vs. Sham conditioning).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single blinded, randomized controlled trial

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: April 30, 2018
• Study Start: November 8, 2017
• Primary Completion: December 31, 2018
• Study Completion: January 31, 2019
• Last Updated: February 5, 2020
• Results First Posted: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Following publication of results. No ending date
• Access Criteria: Data will be available to anyone who wishes to access it through Washington University data repository.

Locations

US (1)