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

NCT ID: NCT03582943

Last Updated: 2018-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-20
• Study Completion Date: 2017-10-01

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.

Conditions

Adults; Older Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

RLIC

Intervention Type: BEHAVIORAL

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

Balance training

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Sham conditioning

Intervention Type: BEHAVIORAL

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

Balance training

Intervention Type: 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.

Interventions

RLIC

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

Intervention Type: BEHAVIORAL

Sham conditioning

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 40-80 years old

2. Had sufficient cognitive skills to provide informed consent and actively participate.

Exclusion Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Catherine E. Lang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catherine Lang, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01HD085930

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIHR01HD085930-Aim3

Identifier Type: -

Identifier Source: org_study_id