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

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ClinicalTrials.gov Identifier: NCT03582943
Recruitment Status : Completed
First Posted : July 11, 2018
Results First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Catherine E. Lang, Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Adults
Older Adults
Interventions Behavioral: RLIC
Behavioral: Sham conditioning
Behavioral: Balance training
Enrollment 82
Recruitment Details Participants recruited by word-of-mouth and through participant registry. Assessed for eligibility, n = 182. Excluded, n = 100 with n = 33 not meeting criteria, n = 64 declined to participate, and n = 3 pilot participants who were not randomized.
Pre-assignment Details  
Arm/Group Title Remote Limb Ischemic Conditioning (RLIC) Sham Conditioning
Hide Arm/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.

RLIC: See descriptions under arm/group descriptions. RLIC 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.

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: 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.

Period Title: Allocated to Groups
Started 42 40
Completed 41 39
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Period Title: Intervention and Follow up
Started 41 39
Completed 37 37
Not Completed 4 2
Reason Not Completed
Withdrawal by Subject             4             2
Period Title: Analyzed
Started 37 37
Completed 33 36
Not Completed 4 1
Reason Not Completed
Protocol Violation             4             1
Arm/Group Title Remote Limb Ischemic Conditioning (RLIC) Sham Conditioning Total
Hide Arm/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.

RLIC: See descriptions under arm/group descriptions. RLIC 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.

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: 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.

Total of all reporting groups
Overall Number of Baseline Participants 33 36 69
Hide Baseline Analysis Population Description
Only persons who made it through the study (e.g. did not withdraw) and did not have protocol violations were included in the analysis
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 36 participants 69 participants
60.4  (10.5) 61.8  (9.0) 61.2  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 36 participants 69 participants
Female
22
  66.7%
25
  69.4%
47
  68.1%
Male
11
  33.3%
11
  30.6%
22
  31.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 33 participants 36 participants 69 participants
Caucasian
25
  75.8%
26
  72.2%
51
  73.9%
African-American
8
  24.2%
10
  27.8%
18
  26.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 33 participants 36 participants 69 participants
33
 100.0%
36
 100.0%
69
 100.0%
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 33 participants 36 participants 69 participants
26.5  (4.4) 26.8  (5.1) 26.6  (4.8)
1.Primary Outcome
Title Change in Balance Score
Hide Description 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.
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who completed the entire protocol and did not have a protocol deviation were analyzed.
Arm/Group Title Remote Limb Ischemic Conditioning (RLIC) Sham Conditioning
Hide Arm/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.

RLIC: See descriptions under arm/group descriptions. RLIC 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.

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: 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.

Overall Number of Participants Analyzed 33 36
Mean (Standard Deviation)
Unit of Measure: seconds
5.55  (4.85) 4.81  (3.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remote Limb Ischemic Conditioning (RLIC), Sham Conditioning
Comments [Not Specified]
Type of Statistical Test Superiority
Comments A priori power analyses was designed to detect at least a 3 second difference in change in balance scores between groups.
Statistical Test of Hypothesis P-Value 0.984
Comments Test of differences between groups.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.74
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Remote Limb Ischemic Conditioning (RLIC), Sham Conditioning
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .455
Comments Test of interaction between age and RLIC vs. sham
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.023
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Remote Limb Ischemic Conditioning (RLIC), Sham Conditioning
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.803
Comments Test of interaction between sex and RLIC vs. sham conditioning
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Remote Limb Ischemic Conditioning (RLIC), Sham Conditioning
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.233
Comments Test of interaction between BMI and RLIC vs. sham conditioning
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.25
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Remote Limb Ischemic Conditioning (RLIC), Sham Conditioning
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Test of interaction between presence of co-morbidities and RLIC vs. sham conditioning
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.12
Estimation Comments [Not Specified]
Time Frame From enrollment through follow-up for a total of 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Remote Limb Ischemic Conditioning (RLIC) Sham Conditioning
Hide Arm/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.

RLIC: See descriptions under arm/group descriptions. RLIC 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.

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: 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.

All-Cause Mortality
Remote Limb Ischemic Conditioning (RLIC) Sham Conditioning
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/36 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Remote Limb Ischemic Conditioning (RLIC) Sham Conditioning
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/36 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Remote Limb Ischemic Conditioning (RLIC) Sham Conditioning
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/36 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Catherine Lang
Organization: Washington University School of Medicine
Phone: 314-286-1945
Responsible Party: Catherine E. Lang, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03582943     History of Changes
Other Study ID Numbers: NIHR01HD085930-Aim3
R01HD085930 ( U.S. NIH Grant/Contract )
First Submitted: June 18, 2018
First Posted: July 11, 2018
Results First Submitted: August 22, 2018
Results First Posted: October 24, 2018
Last Update Posted: October 24, 2018