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

NCT03582943 | Completed Phase 1 Results DMC

• 2 other identifiers: NIHR01HD085930-Aim3R01HD085930
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Adults; Older Adults

Keywords

remote ischemic conditioning, motor learning

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Remote limb ischemic conditioning (RLIC)

EXPERIMENTAL

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.

Behavioral: RLIC; Behavioral: Balance training

Sham conditioning

SHAM COMPARATOR

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.

Behavioral: Sham conditioning; Behavioral: Balance training

Interventions

RLIC BEHAVIORAL

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

Remote limb ischemic conditioning (RLIC)

Sham conditioning BEHAVIORAL

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

Sham conditioning

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.

Remote limb ischemic conditioning (RLIC); Sham conditioning

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Limitations and Caveats

This was a Phase I study in a small sample.

Results Point of Contact

• Title: Dr. Catherine Lang
• Organization: Washington University School of Medicine

langc@wustl.edu

314-286-1945

Study Officials

• Catherine Lang, PT, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are masked to their group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single blinded, randomized, controlled trial

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 11, 2018
• Study Start: October 20, 2015
• Primary Completion: September 15, 2017
• Study Completion: October 1, 2017
• Last Updated: October 24, 2018
• Results First Posted: October 24, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Following publication of results.
• Access Criteria: Data will be available to anyone who wishes to access it through the Washington University data repository.

Locations

US (1)