Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02174770
Other study ID # 395166
Secondary ID 397709
Status Terminated
Phase N/A
First received
Last updated
Start date July 2014
Est. completion date December 2017

Study information

Verified date July 2020
Source Brooke Army Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.
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.

Locations

Country Name City State
United States Brooke Army Medical Center Fort Sam Houston Texas
United States Center for the Intrepid Fort Sam Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Thigh Muscle Strength 6 weeks
See also
  Status Clinical Trial Phase
Completed NCT06280456 - Tranexamic Acid Injection With Different Drainage Clamping Time After Anterior Cruciate Ligament Reconstruction N/A
Active, not recruiting NCT02772770 - Pediatric ACL: Understanding Treatment Options
Terminated NCT00300300 - Anterior Cruciate Ligament (ACL) Reconstruction Using Different Grafts and Surgical Techniques Phase 4
Completed NCT00775892 - SeriACLâ„¢ Device (Gen IB) Trial for Anterior Cruciate Ligament (ACL) Repair Phase 1/Phase 2
Completed NCT04504344 - Non-invasive Brain Stimulation to Improve Quadriceps Muscle Function After Anterior Cruciate Ligament Reconstruction Phase 1
Recruiting NCT06327555 - Study on the Effect of Telerehabilitation Using Wearable Devices After ACL Reconstruction N/A
Recruiting NCT05968729 - Assessment of Gait Adaptation Due to an Asymmetric Walking Protocol N/A
Not yet recruiting NCT05972876 - Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction N/A
Withdrawn NCT03688477 - Iovera° to Treat Pain Associated With ACL Reconstruction and Rehabilitation N/A
Completed NCT02945553 - Prevention of Skeletal Muscle Adaptations to Traumatic Knee Injury and Surgery Phase 1/Phase 2
Recruiting NCT01279759 - Follow up of Patients Operated With Anterior Cruciate Ligament Reconstruction N/A
Completed NCT00245271 - Safety of OMS103HP in Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction Phase 3
Recruiting NCT06131047 - High Intensity Resistance Training With and Without Blood Flow Restriction in ACL Reconstruction N/A
Recruiting NCT06206200 - The Effect of Cognitive Dual-task Rehabilitation on Arthrogenic Muscle Responses After ACL Reconstruction N/A
Recruiting NCT06430775 - Exploring Prolonged AMR in ACL Reconstructed Patients
Not yet recruiting NCT06318039 - Operation ACL: Rehabilitation After Anterior Cruciate Ligament Reconstruction N/A
Recruiting NCT03336060 - Neurophysiologic Correlates of Movement Planning During Complex Jump Landing Tasks and the Role of Cognitive Function N/A
Completed NCT03304561 - The Effect of Contralateral Limb Training on Functional Outcomes in Patients With ACL Reconstruction N/A
Not yet recruiting NCT05619393 - Comparison of Kinematic Movements Between ACL Deficiency With ACL Reconstruction and Healthy People N/A
Completed NCT02604550 - Anterior Cruciate Ligament Pain Study Phase 4