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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AR072572-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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This is a cross-sectional study on the use of personalized blood flow restriction during rehabilitation exercises and its effects on biomechanics on people who have had an anterior cruciate ligament reconstruction and healthy controls
Rehabilitation after surgical reconstruction of the anterior cruciate ligament (ACL) aims to reestablish the function of the knee. However, regaining previous levels of strength is challenging, with long-term muscle weakness frequently reported and thought to play a key role in the increased risk of knee osteoarthritis for individuals with a history of ACL damage. Effectively building muscle strength requires exercises with high resistance loads, however the joint stress and risk of further injury makes these types of activities inappropriate and unsafe for those rehabilitating after ACL reconstruction surgery and other injuries. Personalized blood flow restriction (BFR) training is a technique where the blood flow to the muscles being exercised is controlled by a pressure cuff to a predefined level, and has been shown to increase strength while exercising with significantly lower loads. Early results have been promising, however the effects of BFR on the biomechanics of the exercise as well as the acceptability in the ACL reconstruction population have not been explored. In this application, we propose a cross-sectional study designed to test the acceptability of BFR training for those undergoing rehabilitation from ACL reconstruction surgery and healthy controls during free standing exercises. We will also investigate the biomechanical effects of this rehabilitation technique. This application is part of a larger program of musculoskeletal research in this area being developed by the team. The results from the proposed project will inform the design of a clinical trial of personalized BFR after ACL reconstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anterior cruciate ligament reconstruction group | Experimental | Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery |
|
| Control group | Active Comparator | Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood flow restriction | Device | Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Flexion | Maximum difference in flexion motion of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees | 6 minutes |
| Knee Internal Rotation | Maximum difference in internal rotation of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees | 6 minutes |
| Knee Varus | Maximum difference in varus motion of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees | 6 minutes |
| Hip Flexion | Maximum difference in flexion motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees | 6 minutes |
| Hip Adduction | Maximum difference in adduction motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees | 6 minutes |
| Hip Internal Rotation | Maximum difference in internal rotation motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees | 6 minutes |
| Knee Extension Moment | Maximum difference in extension moment of knee while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise Difficulty Score | Numerical Analogue Scale, 0-10, higher scores indicate greater difficulty | 6 minutes |
| Exercise Discomfort Score | Numerical Analogue Scale, 0-10, higher scores indicate greater discomfort |
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Inclusion Criteria (ACL-R group):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Telfer, EngD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
Data will be made available to researchers on request. Dataset includes all kinematic, kinetic and patient reported data.
11/19/2021 - 11/18/2026
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Knee Flexion | Maximum difference in flexion motion of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees | Posted | Mean | Standard Deviation | Degrees | 6 minutes |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Scott Telfer | University of Washington | 2062292022 | telfers@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 24, 2018 | Jan 4, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 24, 2018 | Jan 4, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 24, 2018 | Jan 4, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000090003 | Blood Flow Restriction Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| 6 minutes |
| Knee Internal Rotation Moment | Maximum difference in internal rotation moment of knee while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram | 6 minutes |
| Knee Adduction Moment | Maximum difference in adduction moment of knee while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram | 6 minutes |
| Hip Extension Moment | Maximum difference in extension moment of hip while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram. | 6 minutes |
| Hip Adduction Moment | Maximum difference in adduction moment of hip while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram | 6 minutes |
| Hip Internal Rotation Moment | Maximum difference in internal rotation moment of hip while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram | 6 minutes |
| 6 minutes |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Knee Internal Rotation | Maximum difference in internal rotation of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees | Posted | Mean | Standard Deviation | Degrees | 6 minutes |
|
|
|
| Primary | Knee Varus | Maximum difference in varus motion of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees | Posted | Mean | Standard Deviation | Degrees | 6 minutes |
|
|
|
| Primary | Hip Flexion | Maximum difference in flexion motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees | Posted | Mean | Standard Deviation | Degrees | 6 minutes |
|
|
|
| Primary | Hip Adduction | Maximum difference in adduction motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees | Posted | Mean | Standard Deviation | Degrees | 6 minutes |
|
|
|
| Primary | Hip Internal Rotation | Maximum difference in internal rotation motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees | Posted | Mean | Standard Deviation | Degrees | 6 minutes |
|
|
|
| Primary | Knee Extension Moment | Maximum difference in extension moment of knee while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram | Posted | Mean | Standard Deviation | Newton meters per kilogram | 6 minutes |
|
|
|
| Primary | Knee Internal Rotation Moment | Maximum difference in internal rotation moment of knee while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram | Posted | Mean | Standard Deviation | Newton meters per kilogram | 6 minutes |
|
|
|
| Primary | Knee Adduction Moment | Maximum difference in adduction moment of knee while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram | Posted | Mean | Standard Deviation | Newton meters per kilogram | 6 minutes |
|
|
|
| Primary | Hip Extension Moment | Maximum difference in extension moment of hip while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram. | Posted | Mean | Standard Deviation | Newton meters per kilogram | 6 minutes |
|
|
|
| Primary | Hip Adduction Moment | Maximum difference in adduction moment of hip while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram | Posted | Mean | Standard Deviation | Newton meters per kilogram | 6 minutes |
|
|
|
| Primary | Hip Internal Rotation Moment | Maximum difference in internal rotation moment of hip while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram | Posted | Mean | Standard Deviation | Newton meters per kilogram | 6 minutes |
|
|
|
| Secondary | Exercise Difficulty Score | Numerical Analogue Scale, 0-10, higher scores indicate greater difficulty | Posted | Mean | 95% Confidence Interval | units on a scale | 6 minutes |
|
|
|
| Secondary | Exercise Discomfort Score | Numerical Analogue Scale, 0-10, higher scores indicate greater discomfort | Posted | Mean | 95% Confidence Interval | units on a scale | 6 minutes |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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 | 0 | 20 | 0 | 20 | 0 | 20 |
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| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |