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

The Washington University

Status and phase: Completed; Phase 1

Conditions: Older Adults; Adults

Treatments: Behavioral: RLIC; Behavioral: Sham conditioning; Behavioral: Balance training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03582943

NIHR01HD085930-Aim3

R01HD085930 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 2 patient groups

Remote limb ischemic conditioning (RLIC)

Experimental group

Description:

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.

Treatment:

Behavioral: Balance training

Behavioral: RLIC

Sham conditioning

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Balance training

Behavioral: Sham conditioning