Trial Outcomes & Findings for Passive Mobilization and Vascular Function (NCT NCT03087643)
NCT ID: NCT03087643
Last Updated: 2019-08-06
Results Overview
Through the use of single Passive Limb Movement (sPLM) test, investigators assessed PLM-induced hyperemia \[ delta peak; ml/min\] in the common femoral artery of both, right and left legs, during and 60 second after a single passive knee flexion and extension lasting 1 second.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
PRE and POST 4 weeks of treatment
Results posted on
2019-08-06
Participant Flow
Participant milestones
| Measure |
Passive Mobilization - PM
Participants will receive 2 times a day, for 5 days a week 30 minutes of passive leg movement treatment including knee flexo-extension in addition to their standard therapies.
Passive mobilization - PM
|
Control Group - Ctrl
Participants will receive ther standard therapies.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
|
Overall Study
COMPLETED
|
22
|
19
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
Passive Mobilization - PM
Participants will receive 2 times a day, for 5 days a week 30 minutes of passive leg movement treatment including knee flexo-extension in addition to their standard therapies.
Passive mobilization - PM
|
Control Group - Ctrl
Participants will receive ther standard therapies.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Death
|
2
|
2
|
Baseline Characteristics
Passive Mobilization and Vascular Function
Baseline characteristics by cohort
| Measure |
Passive Mobilization - PM
n=26 Participants
Participants will receive 2 times a day, for 5 days a week 30 minutes of passive leg movement treatment including knee flexo-extension in addition to their standard therapies.
Passive mobilization - PM
|
Control Group - Ctrl
n=25 Participants
Participants will receive ther standard therapies.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
85 years
STANDARD_DEVIATION 8 • n=5 Participants
|
87 years
STANDARD_DEVIATION 6 • n=7 Participants
|
86 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
26 participants
n=5 Participants
|
25 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Delta Peak Blood Flow during sPLM
|
113.7 ml/min
STANDARD_DEVIATION 69.1 • n=5 Participants
|
100.3 ml/min
STANDARD_DEVIATION 70.4 • n=7 Participants
|
104.5 ml/min
STANDARD_DEVIATION 69.8 • n=5 Participants
|
|
%Flow mediated dilation (FMD)
|
9.6 %
STANDARD_DEVIATION 2.6 • n=5 Participants
|
6.4 %
STANDARD_DEVIATION 2.0 • n=7 Participants
|
7.3 %
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Range of Motion
|
46.45 °
STANDARD_DEVIATION 33.37 • n=5 Participants
|
41.24 °
STANDARD_DEVIATION 6.0 • n=7 Participants
|
44.37 °
STANDARD_DEVIATION 24.56 • n=5 Participants
|
|
Muscle-Tendon Unit Stiffness
|
0.86 N/°
STANDARD_DEVIATION 0.06 • n=5 Participants
|
0.86 N/°
STANDARD_DEVIATION 0.06 • n=7 Participants
|
0.86 N/°
STANDARD_DEVIATION 0.06 • n=5 Participants
|
|
Muscle thickness Vastus Lateralis
|
14.78 mm
STANDARD_DEVIATION 4.09 • n=5 Participants
|
14.52 mm
STANDARD_DEVIATION 3.69 • n=7 Participants
|
14.59 mm
STANDARD_DEVIATION 6.72 • n=5 Participants
|
|
Total Hemoglobin (mmol/L)
|
35.2 mmol/L
STANDARD_DEVIATION 20.8 • n=5 Participants
|
25.3 mmol/L
STANDARD_DEVIATION 12.9 • n=7 Participants
|
29.8 mmol/L
STANDARD_DEVIATION 15.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: PRE and POST 4 weeks of treatmentThrough the use of single Passive Limb Movement (sPLM) test, investigators assessed PLM-induced hyperemia \[ delta peak; ml/min\] in the common femoral artery of both, right and left legs, during and 60 second after a single passive knee flexion and extension lasting 1 second.
Outcome measures
| Measure |
Passive Mobilization - PM
n=22 Participants
Participants will receive 2 times a day, for 5 days a week 30 minutes of passive leg movement treatment including knee flexo-extension in addition to their standard therapies.
Passive mobilization - PM
|
Control Group - Ctrl
n=19 Participants
Participants will receive ther standard therapies.
|
|---|---|---|
|
Change of Delta Peak Blood Flow During sPLM
|
91.9 ml/min
Standard Deviation 30.7
|
-24.7 ml/min
Standard Deviation 27.7
|
PRIMARY outcome
Timeframe: PRE and POST 4 weeks of treatmentThrough the use of Flow-mediated Dilation (FMD) test , investigators assessed the dilation capacity of right the brachial artery (%FMD) during two minutes following 5-minute ischemic occlusion.
Outcome measures
| Measure |
Passive Mobilization - PM
n=22 Participants
Participants will receive 2 times a day, for 5 days a week 30 minutes of passive leg movement treatment including knee flexo-extension in addition to their standard therapies.
Passive mobilization - PM
|
Control Group - Ctrl
n=19 Participants
Participants will receive ther standard therapies.
|
|---|---|---|
|
Change of % FMD
|
0.2 % of FMD
Standard Deviation 2.3
|
0.0 % of FMD
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: PRE and POST 4 weeks of treatmentTotal hemoglobin \[uM\] in both, right and left vastus lateralis, was assessed by means of Near-infrared Spectroscopy \[NIRS\] during the sPLM test.
Outcome measures
| Measure |
Passive Mobilization - PM
n=22 Participants
Participants will receive 2 times a day, for 5 days a week 30 minutes of passive leg movement treatment including knee flexo-extension in addition to their standard therapies.
Passive mobilization - PM
|
Control Group - Ctrl
n=19 Participants
Participants will receive ther standard therapies.
|
|---|---|---|
|
Change of Total Hemoglobin
|
-12.5 mmol/L
Standard Deviation 8.6
|
-2.2 mmol/L
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: PRE and POST 4 weeks of treatmentAssessment of the passive force/joint angle relationship during knee passive mobilization
Outcome measures
| Measure |
Passive Mobilization - PM
n=22 Participants
Participants will receive 2 times a day, for 5 days a week 30 minutes of passive leg movement treatment including knee flexo-extension in addition to their standard therapies.
Passive mobilization - PM
|
Control Group - Ctrl
n=19 Participants
Participants will receive ther standard therapies.
|
|---|---|---|
|
Change of Range of Motion
|
13.13 °
Standard Deviation 0.63
|
3.93 °
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: PRE and POST 4 weeks of treatmentEvaluation of the architectural parameters (fascicle length, pinnation angle, and muscle thickness) of the vastus lateralis muscle by ultrasound
Outcome measures
| Measure |
Passive Mobilization - PM
n=22 Participants
Participants will receive 2 times a day, for 5 days a week 30 minutes of passive leg movement treatment including knee flexo-extension in addition to their standard therapies.
Passive mobilization - PM
|
Control Group - Ctrl
n=19 Participants
Participants will receive ther standard therapies.
|
|---|---|---|
|
Change of Thickness of Vastus Lateralis
|
0.53 mm
Standard Deviation 0.99
|
0.25 mm
Standard Deviation 0.76
|
Adverse Events
Passive Mobilization - PM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Control Group - Ctrl
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place