Knee InjuriesNCT03035266
The Effect of Blood Flow Restriction Training on Muscle Atrophy Following Knee Surgery
A study testing Blood Flow Restriction and Standard rehabilitation in people with Knee Injuries, run by Keller Army Community Hospital at 2 sites in United States.
Trial summary
The investigators will compare differences in quadriceps strength, leg girth, and functional outcome scores between two groups of patients after weeks 6 and 12 as well as 6 months following meniscus or articular cartilage repair/restoration requiring 6 weeks of non-weight bearing or limited weight bearing status in a… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Knee Injuries
- What is being tested?
- Blood Flow Restriction and Standard rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Apr 2017to 12 Mar 2020
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Military healthcare beneficiaries between the age of 18 and 50 years.
- Must intend to remain on station at location of surgery for 6 months from date of surgery.
- Meniscus repair or cartilage restoration technique to include microfracture, osteochondral autograft transfer system, osteochondral allograft transplantation, and autologous chondrocyte implantation following standard post-operative protocol guidelines requiring a 6 week period of non-weight bearing or limited weight bearing in a brace at 0˚ degrees of extension.
Who cannot join
- Concomitant ligamentous repair/reconstruction
- Known pregnancy
- Any medical condition for which aerobic exercise is contraindicated
- Additional back, hip, or knee surgery in the previous 12 months
- History of vascular or cardiac impairment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Womack Army Medical Center
Fort Bragg, North Carolina, 28310
Keller Army Community Hospital
West Point, New York, 10996
About this study
Official title: The Effect of Blood Flow Restriction Training on Muscle Atrophy Following Knee Surgery; A Randomized Control Trial
The investigators will compare differences in quadriceps strength, leg girth, and functional outcome scores between two groups of patients after weeks 6 and 12 as well as 6 months following meniscus or articular cartilage repair/restoration requiring 6 weeks of non-weight bearing or limited weight bearing status in a brace at 0° degrees of knee extension. One group will receive BFR with standard post-operative rehabilitation for 12 weeks followed by the standard protocol progression for the remainder of the treatment program. The other group will receive standard post-operative rehabilitation without BFR for the duration of treatment program.
Read the detailed description
The aim is to compare strength, patient reported outcomes, and functional outcomes of post-operative therapy with and without adjunctive BFR training. To accomplish this task the investigators will compare differences in thigh girth between two groups of patients after the first 6 weeks and 12 weeks as well as 6 months following meniscus or articular cartilage repair requiring 6 weeks of non-weight bearing or limited weight bearing status in a brace at 0˚ degrees of extension. In addition, isokinetic testing of the quadriceps and hamstrings will be performed at 12 weeks and 6 months post-operatively. Lower extremity girth measurements after knee surgery can be performed with good to excellent intra- and inter-rater reliability. Quadriceps strength measured with isokinetic testing is related to performance measures such as jumping. Limb circumference measurement, limb CSA measurement, and isokinetic strength testing are commonly utilized in BFR studies as outcome measures.One group will receive BFR for 12 weeks in addition to standard post-operative rehabilitation and the other group will receive standard post-operative rehabilitation without BFR.
- Conditions
- Knee Injuries
- Being tested
- Blood Flow Restriction, Standard rehabilitation
- Keywords
- blood flow restriction, strength, muscle atrophy, post-operative therapy, knee
- Medical subject headings
- Knee Injuries, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow RestrictionOther
Delfi's Personalized Tourniquet System for Blood Flow Restriction has been specifically designed to safely regulate and control tourniquet pressure. Occlusion pressures will be set at 80% of total occlusive pressure as determined by the Doppler sensor. Each subject will perform 4 sets of each exercise (1 set of 30 repetitions followed by 3 sets of 15 repetitions). The pressure will remain through completion of the final set, but not to exceed 5 minutes. One minute rest without tourniquet application will be performed between 5 minute cycles. Sets and repetitions will remain constant for each subject; however, resistance will be incrementally increased after the subject is able to complete all 75 repetitions without loss of proper form.
Standard rehabilitationOther
Standard of care for post-operative condition
| Study group | Role | What they receive |
|---|---|---|
| Blood Flow Restriction (BFR) | Experimental | All subjects will perform traditional post-operative rehabilitation until discharge from the hospital following surgery and continue until formal discharge from physical therapy upon completion of rehabilitation. One week following surgery, subjects randomized to the BFR group will begin combining BFR with all lower extremity strengthening exercises supervised in clinic up to 3 times per week for 12 weeks. Receives: Other: Blood Flow Restriction |
| Standard rehabilitation (control group) | Active comparator | All subjects will perform traditional post-operative rehabilitation until discharge from the hospital following surgery and continue until formal discharge from physical therapy upon completion of rehabilitation. Receives: Other: Standard rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Torque (foot-pounds), best repetition out of 15 repetitions
Change in isokinetic peak torque knee extension and knee flexion at 180 degrees/sec and at 300 degrees/second
Measured: 12 weeks and 6 months post operative
Secondary outcomes (3)
Thigh circumference (centimeters)
Change in girth measurements of thigh:
10 cm from proximal patella 15 cm from proximal patella 33% length from proximal patella to inguinal crease
Measured: baseline, 6 weeks, 12 weeks, and 6 months
Visual Analog Scale (VAS), 0 to 40 mm self report pain scale
Change in VAS for Pain
Measured: baseline, 6 weeks, 12 weeks, and 6 months
Lower Extremity Functional Scale (LEFS) Questionnaire
Change in LEFS Outcome Measure
Measured: baseline, 6 weeks, 12 weeks, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start5 Apr 2017
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies 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
- Model description
- This is a prospective, randomized control trial. After consenting, subjects will be randomized to one of two groups by using a computer generated random number.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keller Army Community Hospital
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, John Mason, Keller Army Community Hospital
- Investigators
- John S Mason, DSc, DPT, Principal investigator, Keller Army Community Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035266
- Sponsor's protocol ID
- 16KACH016
- Status last verified
- Aug 2020
- First submitted
- 20 Jan 2017
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blood Flow Restriction Training on Muscle Atrophy Following Knee Surgery; A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03035266
- Acronym / sponsor ID
- 16KACH016
- Conditions
- Knee Injuries
- Keywords
- blood flow restriction, strength, muscle atrophy, post-operative therapy, knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Keller Army Community HospitalUS federal agency
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 27 Jan 2017 (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.
The investigators will compare differences in quadriceps strength, leg girth, and functional outcome scores between two groups of patients after weeks 6 and 12 as well as 6 months following meniscus or articular cartilage repair/restoration requiring 6 weeks of non-weight bearing or limited weight bearing status in a brace at 0° degrees of knee extension. One group will receive BFR with standard post-operative rehabilitation for 12 weeks followed by the standard protocol progression for the remainder of the treatment program. The other group will receive standard post-operative rehabilitation without BFR for the duration of treatment program.
Detailed description
The aim is to compare strength, patient reported outcomes, and functional outcomes of post-operative therapy with and without adjunctive BFR training. To accomplish this task the investigators will compare differences in thigh girth between two groups of patients after the first 6 weeks and 12 weeks as well as 6 months following meniscus or articular cartilage repair requiring 6 weeks of non-weight bearing or limited weight bearing status in a brace at 0˚ degrees of extension. In addition, isokinetic testing of the quadriceps and hamstrings will be performed at 12 weeks and 6 months post-operatively. Lower extremity girth measurements after knee surgery can be performed with good to excellent intra- and inter-rater reliability. Quadriceps strength measured with isokinetic testing is related to performance measures such as jumping. Limb circumference measurement, limb CSA measurement, and isokinetic strength testing are commonly utilized in BFR studies as outcome measures.One group will receive BFR for 12 weeks in addition to standard post-operative rehabilitation and the other group will receive standard post-operative rehabilitation without BFR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized control trial. After consenting, subjects will be randomized to one of two groups by using a computer generated random number.
| Arm | Type | Receives |
|---|---|---|
| Blood Flow Restriction (BFR) | Experimental | Other: Blood Flow RestrictionAll subjects will perform traditional post-operative rehabilitation until discharge from the hospital following surgery and continue until formal discharge from physical therapy upon completion of rehabilitation. One week following surgery, subjects randomized to the BFR group will begin combining BFR with all lower extremity strengthening exercises supervised in clinic up to 3 times per week for 12 weeks. |
| Standard rehabilitation (control group) | Active comparator | Other: Standard rehabilitationAll subjects will perform traditional post-operative rehabilitation until discharge from the hospital following surgery and continue until formal discharge from physical therapy upon completion of rehabilitation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Military healthcare beneficiaries between the age of 18 and 50 years.
- Must intend to remain on station at location of surgery for 6 months from date of surgery.
- Meniscus repair or cartilage restoration technique to include microfracture, osteochondral autograft transfer system, osteochondral allograft transplantation, and autologous chondrocyte implantation following standard post-operative protocol guidelines requiring a 6 week period of non-weight bearing or limited weight bearing in a brace at 0˚ degrees of extension.
Key exclusion criteria (5 listed)
- Concomitant ligamentous repair/reconstruction
- Known pregnancy
- Any medical condition for which aerobic exercise is contraindicated
- Additional back, hip, or knee surgery in the previous 12 months
- History of vascular or cardiac impairment
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 RestrictionDelfi's Personalized Tourniquet System for Blood Flow Restriction has been specifically designed to safely regulate and control tourniquet pressure. Occlusion pressures will be set at 80% of total occlusive pressure as determined by the Doppler sensor. Each subject will perform 4 sets of each exercise (1 set of 30 repetitions followed by 3 sets of 15 repetitions). The pressure will remain through completion of the final set, but not to exceed 5 minutes. One minute rest without tourniquet application will be performed between 5 minute cycles. Sets and repetitions will remain constant for each subject; however, resistance will be incrementally increased after the subject is able to complete all 75 repetitions without loss of proper form. | Other | Blood Flow Restriction (BFR) |
| Standard rehabilitationStandard of care for post-operative condition | Other | Standard rehabilitation (control group) |
Primary outcome
Peak Torque (foot-pounds), best repetition out of 15 repetitions
Time frame: 12 weeks and 6 months post operative
Change in isokinetic peak torque knee extension and knee flexion at 180 degrees/sec and at 300 degrees/second
3 secondary outcomes
Thigh circumference (centimeters)
Time frame: baseline, 6 weeks, 12 weeks, and 6 months
Visual Analog Scale (VAS), 0 to 40 mm self report pain scale
Time frame: baseline, 6 weeks, 12 weeks, and 6 months
Lower Extremity Functional Scale (LEFS) Questionnaire
Time frame: baseline, 6 weeks, 12 weeks, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Individual participant dataSharing planned: No
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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.
John S Mason, DSc, DPT principal investigator
Keller Army Community Hospital
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 and Standard rehabilitation in people with Knee Injuries, run by Keller Army Community Hospital 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 21 Aug 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peak Torque (foot-pounds), best repetition out of 15 repetitions (time frame: 12 weeks and 6 months post operative). 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 21 Aug 2020.