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Blood Flow Restriction Training in Rehabilitation Patients

Primary Purpose

Anterior Cruciate Ligament Reconstruction, Volumetric Muscle Loss, Chronic Thigh Muscle Weakness

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Flow Restriction (BFR) Training
Standard ACSM-guided strength training
Sponsored by
Brooke Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Reconstruction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • One of the following: (1) s/p ACL reconstruction within the last three months prior to initiation of study training, (2) s/p knee arthroscopy within the last 2 weeks prior to initiation of study training, (3) S/p lower extremity trauma, unilateral with thigh weakness of at lest a 20% deficit compared to contralateral side and at least 6 months out from most recent trauma or surgery
  • Fluent in English and able to consent

Exclusion Criteria:

  • Contralateral lower extremity involvement resulting in less than normal range of motion, muscle strength, or daily pain greater than 5/10.
  • Pregnancy, verbal reporting
  • Recent history of deep vein thrombosis, within the 12 months or on active treatment
  • History of endothelial dysfunction, peripheral vascular disease, hypertension, diabetes, or people prone to capillary ruptures (bruising) (determined by verbal reporting by the patient)
  • Active Infection
  • Cancer (current diagnosis)

Sites / Locations

  • Brooke Army Medical Center
  • Center for the Intrepid

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Other

Experimental

Active Comparator

Arm Label

ACL BFR group

ACL Standard Therapy

Chronic Muscle Weakness

Knee Arthroscopy BFR

Knee Arthroscopy Standard

Arm Description

This group is patients with post-op from ACL reconstruction who are randomized into the blood flow restriction arm. They will receive BFR strength training as part of their post-operative physical therapy program for two months during normal post-op rehab.

This group is patients with post-op from ACL reconstruction who are randomized into the standard therapy arm. They will receive ACSM guided-strength training as part of their post-operative physical therapy program.

This is a crossover group where all subjects will be randomized to begin with either standard or blood flow restriction therapy for 4 weeks. After completion of the initial training, each subject will be switched to the opposite in an AB/BA crossover design.

This group is patients with post-op from soft-tissue only knee arthroscopy who are randomized into the blood flow restriction arm. They will receive BFR strength training as part of their post-operative physical therapy program for two months during normal post-op rehab.

This group is patients with post-op from soft-tissue only knee arthroscopy who are randomized into the standard physical therapy arm. They will receive ACSM-guided strength training as part of their post-operative physical therapy program during normal post-op rehab.

Outcomes

Primary Outcome Measures

Thigh Muscle Strength

Secondary Outcome Measures

Full Information

First Posted
June 23, 2014
Last Updated
July 8, 2020
Sponsor
Brooke Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02174770
Brief Title
Blood Flow Restriction Training in Rehabilitation Patients
Official Title
Blood Flow Restriction Training Versus Standard Physical Therapy in Post-Operative and Post-Traumatic Rehabilitation Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Lack of resources
Study Start Date
July 2014 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brooke Army Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Occlusion training, resistance exercise performed with a specialized venous tourniquet, leads to beneficial changes in muscle at low resistance and minimal stress on the nearby joint. This novel resistance training has the potential to greatly improve extremity muscle strength gains for rehabilitation patients who are unable for medical reasons to perform high resistance exercise. Our study will explore this with specific rehabilitation populations: post-operative knee scopes, post-operative anterior cruciate ligament (ACL) reconstruction patients who have acute post-operative changes in thigh muscle function and chronic thigh weakness. The primary outcome is to achieve accelerated functional thigh recovery with outcome measures including thigh strength, validated questionnaires, and validated functional testing. Occlusion training can enhance rehab patients outcomes, reduce the cost of care, and improve the skills and efficiency of care providers.
Detailed Description
Occlusion training is the restriction of venous outflow from an extremity with the use of a tourniquet during weight-training or resistance exercises. The technique is a safe and effective method of improving strength through muscle hypertrophy in healthy, active individuals (1-7). The technique has also been shown to be safe and effective in patient populations with various comorbidities (8).These strength gains can be achieved while training with loads as low as 20% of an individual's one repetition maximum (1RM). This is contrary to the American College of Sports Medicine (ACSM) weight-training guidelines that state muscle hypertrophy can only be achieved when an individual lifts loads close to 80% of the 1RM (9). The purpose of this project is to compare occlusion resistance training to traditional resistance training methods for rehabilitation patients. This will include both an acute post-operative ACL reconstruction cohort and a chronic thigh weakness cohort. Post-operative lower extremity weakness as well as chronic muscle weakness after trauma correlate with lower functional performance.(10,11) We will treat the patients and follow these two cohorts simultaneously. Specific Aim 1: To determine if occlusion training will accelerate the recovery of thigh muscle function and strength in post-operative anterior cruciate ligament (ACL) reconstruction as compared to a standard post-operative rehabilitation protocol. Specific Aim 2: To determine if occlusion training will increase quadricep and hamstring muscle function for battlefield wounded warriors with severe thigh weakness as a result of trauma or volumetric muscle loss as compared to standard ACSM resistance training guidelines. Specific Aim 3: To determine if occlusion training will accelerate the recovery of thigh muscle function and strength in post-operative soft tissue knee arthroscopy as compared to a standard post-operative rehabilitation protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Reconstruction, Volumetric Muscle Loss, Chronic Thigh Muscle Weakness, Knee Arthroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACL BFR group
Arm Type
Experimental
Arm Description
This group is patients with post-op from ACL reconstruction who are randomized into the blood flow restriction arm. They will receive BFR strength training as part of their post-operative physical therapy program for two months during normal post-op rehab.
Arm Title
ACL Standard Therapy
Arm Type
Active Comparator
Arm Description
This group is patients with post-op from ACL reconstruction who are randomized into the standard therapy arm. They will receive ACSM guided-strength training as part of their post-operative physical therapy program.
Arm Title
Chronic Muscle Weakness
Arm Type
Other
Arm Description
This is a crossover group where all subjects will be randomized to begin with either standard or blood flow restriction therapy for 4 weeks. After completion of the initial training, each subject will be switched to the opposite in an AB/BA crossover design.
Arm Title
Knee Arthroscopy BFR
Arm Type
Experimental
Arm Description
This group is patients with post-op from soft-tissue only knee arthroscopy who are randomized into the blood flow restriction arm. They will receive BFR strength training as part of their post-operative physical therapy program for two months during normal post-op rehab.
Arm Title
Knee Arthroscopy Standard
Arm Type
Active Comparator
Arm Description
This group is patients with post-op from soft-tissue only knee arthroscopy who are randomized into the standard physical therapy arm. They will receive ACSM-guided strength training as part of their post-operative physical therapy program during normal post-op rehab.
Intervention Type
Other
Intervention Name(s)
Blood Flow Restriction (BFR) Training
Other Intervention Name(s)
Low resistance training, Occlusion training
Intervention Description
This is a modality of physical therapy where during low-load resistance activity, the venous return of blood from an extremity is limited only during the duration of the exercise. This can be accomplished through multiple means. For the purposes of our study, we will use an inflatable tourniquet.
Intervention Type
Other
Intervention Name(s)
Standard ACSM-guided strength training
Other Intervention Name(s)
physical therapy
Intervention Description
This is the standard protocol to be used for post-operative and other physical therapy patients for rehabilitation. It includes the use of American College of Sports Medicine-guidelines for how much weight to use during the strength training portion of the rehabilitation.
Primary Outcome Measure Information:
Title
Thigh Muscle Strength
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: One of the following: (1) s/p ACL reconstruction within the last three months prior to initiation of study training, (2) s/p knee arthroscopy within the last 2 weeks prior to initiation of study training, (3) S/p lower extremity trauma, unilateral with thigh weakness of at lest a 20% deficit compared to contralateral side and at least 6 months out from most recent trauma or surgery Fluent in English and able to consent Exclusion Criteria: Contralateral lower extremity involvement resulting in less than normal range of motion, muscle strength, or daily pain greater than 5/10. Pregnancy, verbal reporting Recent history of deep vein thrombosis, within the 12 months or on active treatment History of endothelial dysfunction, peripheral vascular disease, hypertension, diabetes, or people prone to capillary ruptures (bruising) (determined by verbal reporting by the patient) Active Infection Cancer (current diagnosis)
Facility Information:
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Center for the Intrepid
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States

12. IPD Sharing Statement

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Blood Flow Restriction Training in Rehabilitation Patients

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