Trial Outcomes & Findings for Effects of RLIC on Motor Learning in Middle-aged and Older Adults (NCT NCT03582943)
NCT ID: NCT03582943
Last Updated: 2018-10-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
82 participants
Primary outcome timeframe
1 week
Results posted on
2018-10-24
Participant Flow
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.
Participant milestones
| Measure |
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.
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
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.
|
|---|---|---|
|
Allocated to Groups
STARTED
|
42
|
40
|
|
Allocated to Groups
COMPLETED
|
41
|
39
|
|
Allocated to Groups
NOT COMPLETED
|
1
|
1
|
|
Intervention and Follow up
STARTED
|
41
|
39
|
|
Intervention and Follow up
COMPLETED
|
37
|
37
|
|
Intervention and Follow up
NOT COMPLETED
|
4
|
2
|
|
Analyzed
STARTED
|
37
|
37
|
|
Analyzed
COMPLETED
|
33
|
36
|
|
Analyzed
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
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.
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
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.
|
|---|---|---|
|
Allocated to Groups
Withdrawal by Subject
|
1
|
1
|
|
Intervention and Follow up
Withdrawal by Subject
|
4
|
2
|
|
Analyzed
Protocol Violation
|
4
|
1
|
Baseline Characteristics
Effects of RLIC on Motor Learning in Middle-aged and Older Adults
Baseline characteristics by cohort
| Measure |
Remote Limb Ischemic Conditioning (RLIC)
n=33 Participants
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
n=36 Participants
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
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
61.8 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
61.2 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African-American
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Body mass index
|
26.5 kg/m^2
STANDARD_DEVIATION 4.4 • n=5 Participants
|
26.8 kg/m^2
STANDARD_DEVIATION 5.1 • n=7 Participants
|
26.6 kg/m^2
STANDARD_DEVIATION 4.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: Only participants who completed the entire protocol and did not have a protocol deviation were analyzed.
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.
Outcome measures
| Measure |
Remote Limb Ischemic Conditioning (RLIC)
n=33 Participants
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
n=36 Participants
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.
|
|---|---|---|
|
Change in Balance Score
|
5.55 seconds
Standard Deviation 4.85
|
4.81 seconds
Standard Deviation 3.47
|
Adverse Events
Remote Limb Ischemic Conditioning (RLIC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Conditioning
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Catherine Lang
Washington University School of Medicine
Phone: 314-286-1945
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place