Blood Flow Restriction Training in Rehabilitation Patients

NCT ID: NCT02174770

Last Updated: 2020-07-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-12-31

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.

Conditions

Anterior Cruciate Ligament Reconstruction; Volumetric Muscle Loss; Chronic Thigh Muscle Weakness; Knee Arthroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACL BFR group

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.

Group Type: EXPERIMENTAL

Blood Flow Restriction (BFR) Training

Intervention Type: OTHER

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.

ACL Standard Therapy

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.

Group Type: ACTIVE_COMPARATOR

Standard ACSM-guided strength training

Intervention Type: OTHER

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.

Chronic Muscle Weakness

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.

Group Type: OTHER

Blood Flow Restriction (BFR) Training

Intervention Type: OTHER

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.

Standard ACSM-guided strength training

Intervention Type: OTHER

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.

Knee Arthroscopy BFR

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.

Group Type: EXPERIMENTAL

Blood Flow Restriction (BFR) Training

Intervention Type: OTHER

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.

Knee Arthroscopy Standard

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.

Group Type: ACTIVE_COMPARATOR

Standard ACSM-guided strength training

Intervention Type: OTHER

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.

Interventions

Blood Flow Restriction (BFR) Training

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

Standard ACSM-guided strength training

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.

Intervention Type: OTHER

Other Intervention Names

Low resistance training; Occlusion training; physical therapy

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brooke Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Christina Hylden

Orthopaedic Surgery Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Center for the Intrepid

Fort Sam Houston, Texas, United States

Countries

United States

Other Identifiers

397709

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

395166

Identifier Type: -

Identifier Source: org_study_id