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

Phase 1

Completed

• Conditions: Adults; Older Adults
• Interventions: Behavioral: RLIC; Behavioral: Sham conditioning; Behavioral: Balance training

• Registration Number: NCT03582943
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-10-20
• Primary Completion: 2017-09-15
• Study Completion: 2017-10-01
• Study First Submitted: 2018-06-18
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-07-11
• Results First Submitted: 2018-08-22
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-23
• Last Update Submitted: 2018-10-23
• Results First Posted: 2018-10-24
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote limb ischemic conditioning (RLIC)	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.
Remote limb ischemic conditioning (RLIC)	Balance training	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.
Sham conditioning	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.
Sham conditioning	Balance training	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.

Primary Outcome Measures

Name	Time	Method
Change in Balance Score	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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States