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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
Results First Posted : October 24, 2018
Last Update Posted : October 24, 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

Tracking Information
First Submitted Date  ICMJE June 18, 2018
First Posted Date  ICMJE July 11, 2018
Results First Submitted Date  ICMJE August 22, 2018
Results First Posted Date  ICMJE October 24, 2018
Last Update Posted Date October 24, 2018
Actual Study Start Date  ICMJE October 20, 2015
Actual Primary Completion Date September 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03582943 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of RLIC on Motor Learning in Middle-aged and Older Adults
Official Title  ICMJE Effects of Remote Limb Ischemic Conditioning on Motor Learning in Middle-aged and Older Adults
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Adults
  • Older Adults
Intervention  ICMJE
  • Behavioral: RLIC
    See descriptions under arm/group descriptions. RLIC is delivered for 7 visits, occurring on consecutive weekdays.
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: RLIC
    • Behavioral: Balance training
  • 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.
    Interventions:
    • Behavioral: Sham conditioning
    • Behavioral: Balance training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2018)
82
Original Actual Enrollment  ICMJE
 (submitted: June 26, 2018)
89
Actual Study Completion Date  ICMJE October 1, 2017
Actual Primary Completion Date September 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03582943
Other Study ID Numbers  ICMJE NIHR01HD085930-Aim3
R01HD085930 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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
Responsible Party Catherine E. Lang, Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Catherine Lang, PT, PhD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP