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Completed

NCT Number: NCT03582943

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

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.

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Key information

Conditions

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

(determined by self-report):

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

Treatment and study plan

RLIC

Behavioral

See descriptions under arm/group descriptions. RLIC is delivered for 7 visits, occurring on consecutive weekdays.

Sham conditioning

Behavioral

See descriptions under arm/group descriptions. Sham conditioning is delivered for 7 visits, occurring on consecutive weekdays.

Balance training

Behavioral

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Effects of Remote Limb Ischemic Conditioning on Motor Learning in Middle-aged and Older Adults

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 11, 2018
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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