Anterior Cruciate Ligament ReconstructionNCT02174770
Blood Flow Restriction Training in Rehabilitation Patients
A study testing Blood Flow Restriction (BFR) Training and Standard ACSM-guided strength training in people with Anterior Cruciate Ligament Reconstruction and Volumetric Muscle Loss, run by Brooke Army Medical Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction, Volumetric Muscle Loss, Chronic Thigh Muscle Weakness
- What is being tested?
- Blood Flow Restriction (BFR) Training and Standard ACSM-guided strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Center for the Intrepid
Fort Sam Houston, Texas, 78234
About this study
Official title: Blood Flow Restriction Training Versus Standard Physical Therapy in Post-Operative and Post-Traumatic Rehabilitation Patients
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.
Read the 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
- Being tested
- Blood Flow Restriction (BFR) Training, Standard ACSM-guided strength training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction (BFR) TrainingOther
Also called Low resistance training, Occlusion 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 trainingOther
Also called physical therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| ACL BFR group | Experimental | 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. Receives: Other: Blood Flow Restriction (BFR) Training |
| ACL Standard Therapy | Active comparator | 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. Receives: Other: Standard ACSM-guided strength training |
| Chronic Muscle Weakness | Other | 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. Receives: Other: Blood Flow Restriction (BFR) Training; Other: Standard ACSM-guided strength training |
| Knee Arthroscopy BFR | Experimental | 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. Receives: Other: Blood Flow Restriction (BFR) Training |
| Knee Arthroscopy Standard | Active comparator | 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. Receives: Other: Standard ACSM-guided strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thigh Muscle Strength
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: Lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Christina Hylden, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174770
- Sponsor's protocol ID
- 395166
- Other IDs
- 397709
- Status last verified
- Jul 2020
- First submitted
- 23 Jun 2014
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction Training Versus Standard Physical Therapy in Post-Operative and Post-Traumatic Rehabilitation Patients
- ClinicalTrials.gov ID
- NCT02174770
- Acronym / sponsor ID
- 395166
- Conditions
- Anterior Cruciate Ligament Reconstruction, Volumetric Muscle Loss, Chronic Thigh Muscle Weakness, Knee Arthroscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of resources
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- Jul 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ACL BFR group | Experimental | Other: Blood Flow Restriction (BFR) TrainingThis 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. |
| ACL Standard Therapy | Active comparator | Other: Standard ACSM-guided strength trainingThis 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. |
| Chronic Muscle Weakness | Other | Other: Blood Flow Restriction (BFR) Training, Other: Standard ACSM-guided strength trainingThis 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. |
| Knee Arthroscopy BFR | Experimental | Other: Blood Flow Restriction (BFR) TrainingThis 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. |
| Knee Arthroscopy Standard | Active comparator | Other: Standard ACSM-guided strength trainingThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow Restriction (BFR) TrainingAlso: Low resistance training, Occlusion trainingThis 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. | Other | ACL BFR group, Chronic Muscle Weakness, Knee Arthroscopy BFR |
| Standard ACSM-guided strength trainingAlso: physical therapyThis 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. | Other | ACL Standard Therapy, Chronic Muscle Weakness, Knee Arthroscopy Standard |
Primary outcome
Thigh Muscle Strength
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Lack of resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
Related trials for Anterior Cruciate Ligament Reconstruction
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Interventions to Enhance Quadriceps Output After ACLR
ACL
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction (BFR) Training and Standard ACSM-guided strength training in people with Anterior Cruciate Ligament Reconstruction and Volumetric Muscle Loss, run by Brooke Army Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of resources). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thigh Muscle Strength (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.