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

Older Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03582943
• Other study ID #: NIHR01HD085930-Aim3
• Secondary ID: R01HD085930
• Status: Completed
• Phase: Phase 1
• Start date: October 20, 2015
• Est. completion date: October 1, 2017

Study information

• Verified date: October 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: October 1, 2017
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adults
• Older Adults

Intervention

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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Balance Score	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.	1 week