Trial Outcomes & Findings for Personalized Blood Flow Restriction for Anterior Cruciate Ligament Rehabilitation (NCT NCT04635579)

NCT ID: NCT04635579

Last Updated: 2022-02-28

Results Overview

Maximum difference in flexion motion of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 6 minutes
• Results posted on: 2022-02-28

Participant Flow

Participant milestones

Measure	Anterior Cruciate Ligament Reconstruction Group Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure	Control Group Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Personalized Blood Flow Restriction for Anterior Cruciate Ligament Rehabilitation

Baseline characteristics by cohort

Measure	Anterior Cruciate Ligament Reconstruction Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure	Control Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure	Total n=40 Participants Total of all reporting groups
Age, Continuous	30.6 years n=5 Participants	28 years n=7 Participants	29.3 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	17 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	2 Participants n=5 Participants	1 Participants n=7 Participants	3 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	18 Participants n=7 Participants	35 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 United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 minutes

Maximum difference in flexion motion of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees

Outcome measures

Measure	Anterior Cruciate Ligament Reconstruction Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure	Control Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure
Knee Flexion	-0.05 Degrees Standard Deviation 2.0	0.01 Degrees Standard Deviation 5.14

PRIMARY outcome

Timeframe: 6 minutes

Maximum difference in internal rotation of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees

Outcome measures

Measure	Anterior Cruciate Ligament Reconstruction Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure	Control Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure
Knee Internal Rotation	1.19 Degrees Standard Deviation 1.4	-0.03 Degrees Standard Deviation 1.97

PRIMARY outcome

Timeframe: 6 minutes

Maximum difference in varus motion of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees

Outcome measures

Measure	Anterior Cruciate Ligament Reconstruction Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure	Control Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure
Knee Varus	0.12 Degrees Standard Deviation 1.25	-0.36 Degrees Standard Deviation 2.61

PRIMARY outcome

Timeframe: 6 minutes

Maximum difference in flexion motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees

Outcome measures

Measure	Anterior Cruciate Ligament Reconstruction Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure	Control Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure
Hip Flexion	-1.73 Degrees Standard Deviation 2.27	-2.9 Degrees Standard Deviation 8.15

PRIMARY outcome

Timeframe: 6 minutes

Maximum difference in adduction motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees

Outcome measures

Measure	Anterior Cruciate Ligament Reconstruction Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure	Control Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure
Hip Adduction	0.61 Degrees Standard Deviation 1.9	1.52 Degrees Standard Deviation 2.6

PRIMARY outcome

Timeframe: 6 minutes

Maximum difference in internal rotation motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees

Outcome measures

Measure	Anterior Cruciate Ligament Reconstruction Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure	Control Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure
Hip Internal Rotation	1.49 Degrees Standard Deviation 2.37	1.05 Degrees Standard Deviation 2.6

PRIMARY outcome

Timeframe: 6 minutes

Maximum difference in extension moment of knee while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram

Outcome measures

Measure	Anterior Cruciate Ligament Reconstruction Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure	Control Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure
Knee Extension Moment	0.31 Newton meters per kilogram Standard Deviation 0.21	0.6 Newton meters per kilogram Standard Deviation 0.26

PRIMARY outcome

Timeframe: 6 minutes

Maximum difference in internal rotation moment of knee while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram

Outcome measures

Measure	Anterior Cruciate Ligament Reconstruction Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure	Control Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure
Knee Internal Rotation Moment	-0.01 Newton meters per kilogram Standard Deviation 0.05	-0.02 Newton meters per kilogram Standard Deviation 0.07

PRIMARY outcome

Timeframe: 6 minutes

Maximum difference in adduction moment of knee while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram

Outcome measures

Measure	Anterior Cruciate Ligament Reconstruction Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure	Control Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure
Knee Adduction Moment	0.06 Newton meters per kilogram Standard Deviation 0.05	0.12 Newton meters per kilogram Standard Deviation 0.07

PRIMARY outcome

Timeframe: 6 minutes

Maximum difference in extension moment of hip while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram.

Outcome measures

Measure	Anterior Cruciate Ligament Reconstruction Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure	Control Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure
Hip Extension Moment	0.09 Newton meters per kilogram Standard Deviation 0.16	0.2 Newton meters per kilogram Standard Deviation 0.14

PRIMARY outcome

Timeframe: 6 minutes

Maximum difference in adduction moment of hip while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram

Outcome measures

Measure	Anterior Cruciate Ligament Reconstruction Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure	Control Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure
Hip Adduction Moment	-0.01 Newton meters per kilogram Standard Deviation 0.1	-0.07 Newton meters per kilogram Standard Deviation 0.14

PRIMARY outcome

Timeframe: 6 minutes

Maximum difference in internal rotation moment of hip while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram

Outcome measures

Measure	Anterior Cruciate Ligament Reconstruction Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure	Control Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure
Hip Internal Rotation Moment	-0.02 Newton meters per kilogram Standard Deviation 0.13	0.05 Newton meters per kilogram Standard Deviation 0.05

SECONDARY outcome

Timeframe: 6 minutes

Numerical Analogue Scale, 0-10, higher scores indicate greater difficulty

Outcome measures

Measure	Anterior Cruciate Ligament Reconstruction Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure	Control Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure
Exercise Difficulty Score	4.0 units on a scale Interval 3.0 to 5.5	5.0 units on a scale Interval 4.5 to 6.0

SECONDARY outcome

Timeframe: 6 minutes

Numerical Analogue Scale, 0-10, higher scores indicate greater discomfort

Outcome measures

Measure	Anterior Cruciate Ligament Reconstruction Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure	Control Group n=20 Participants Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries Blood flow restriction: Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure
Exercise Discomfort Score	4.0 units on a scale Interval 3.5 to 5.5	4.5 units on a scale Interval 3.0 to 5.0

Adverse Events

Anterior Cruciate Ligament Reconstruction Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

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 Scott Telfer

University of Washington

Phone: 2062292022

Email: telfers@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place