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Effects of RLIC on Motor Learning in Middle-aged and Older Adults

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ClinicalTrials.gov Identifier: NCT03582943
Recruitment Status : Completed
First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Catherine E. Lang, Washington University School of Medicine

Brief Summary:
The purpose of this research is to determine if the beneficial effects of remote limb ischemic conditioning on learning seen in young adults are found in middle-aged and older adults.

Condition or disease Intervention/treatment Phase
Adults Older Adults Behavioral: RLIC Behavioral: Sham conditioning Behavioral: Balance training Phase 1

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 next step is to determine which individuals would receive maximum benefit from RLIC before applying these findings to clinical rehabilitation populations such as stroke. Numerous factors, such as age, body mass index (BMI), sex, and cardiovascular comorbidities may influence the response. The current study determines if RLIC can enhance learning in middle-aged and older adults with their burden of co-morbidities.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single blinded, randomized, controlled trial
Masking: Single (Participant)
Masking Description: Participants are masked to their group assignment.
Primary Purpose: Treatment
Official Title: Effects of Remote Limb Ischemic Conditioning on Motor Learning in Middle-aged and Older Adults
Actual Study Start Date : October 20, 2015
Actual Primary Completion Date : September 15, 2017
Actual Study Completion Date : October 1, 2017

Arm Intervention/treatment
Experimental: Remote limb ischemic conditioning (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 1-7.
Behavioral: RLIC
See descriptions under arm/group descriptions. RLIC is delivered for 7 visits, occurring on consecutive weekdays.

Behavioral: Balance training
All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. This is a motor learning task. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.

Sham Comparator: 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 1-7.
Behavioral: Sham conditioning
See descriptions under arm/group descriptions. Sham conditioning is delivered for 7 visits, occurring on consecutive weekdays.

Behavioral: Balance training
All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. This is a motor learning task. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.




Primary Outcome Measures :
  1. Change in Balance score [ Time Frame: 1 week ]
    Balance score at the end of training - balance score at baseline, where balance score is the average amount of time in seconds that a participant maintains the stability platform within ±3° of horizontal position during 5 trials of 30 seconds each. Five trials are averaged to form the balance score at each time point.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 40-80 years old
  2. Had sufficient cognitive skills to provide informed consent and actively participate.

Exclusion Criteria (determined by self-report):

  1. History of a neurological condition, balance impairment, or vestibular disorder.
  2. History of attentional disorders (ADD/ADHD) that could affect learning.
  3. History of sleep apnea which could confound the effects of RLIC.
  4. Presence of lower extremity condition, injury, or surgery that would compromise performance on the balance task.
  5. Learning disability, sensory, or communication problem that would prevent completion of the study.
  6. History of epilepsy, peripheral vascular disease, or blood diathesis which could contraindicate RLIC.
  7. Current intensive weight lifting or interval training exercise which could confound the effects of RLIC.
  8. Current substance abuse or dependence.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582943


Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Catherine Lang, PT, PhD Washington University School of Medicine

Responsible Party: Catherine E. Lang, Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03582943     History of Changes
Other Study ID Numbers: NIHR01HD085930-Aim3
R01HD085930 ( U.S. NIH Grant/Contract )
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After completion of the study, all of the individual participant data after de-identification will be submitted to Washington University data repository.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Following publication of results.
Access Criteria: Data will be available to anyone who wishes to access it through the Washington University data repository.
URL: https://openscholarship.wustl.edu

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Catherine E. Lang, Washington University School of Medicine:
remote ischemic conditioning, motor learning