Total Knee ArthroplastyBFRT-TKANCT04366336
BFRT vs Standard PT After Total Knee Arthroplasty
A study testing Blood Flow Restriction Training and Standard Physical Therapy in people with Total Knee Arthroplasty, run by Norton Healthcare at 1 site in United States.
Trial summary
Background Blood flow restriction training (BFRT) uses a specialized tourniquet system to restrict arterial inflow and venous outflow to the limb during low-load resistance exercise. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Blood Flow Restriction Training and Standard Physical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2021to 29 Dec 2021
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Status post primary TKA and cleared by surgeon for Physical Therapy.
- Ages 50-79 years old
- Able to participate fully in PT
- Primary cruciate retaining or posterior stabilized TKA.
- Knee Range of Motion of surgical extremity is a minimum of 5° on full extension to 90° on full flexion
- Exclusion Criteria:
Show all 30Show fewer
- Unable to consent for study participation
- Unable to participate in preoperative testing
- Any ligamentous or osseous reconstruction at time of surgery that limits weight bearing
- History of Deep Vein Thrombosis
- Injury or recent procedure to uninvolved extremity within 6 months
- History of endothelial dysfunction
- History of Peripheral Vascular Disease including varicose veins
- Easy bruisability
- TKA is revision
- History of surgical wound complication on involved extremity
- History of stroke
- History of dementia
- History of neuromuscular disorder
- History of Chronic Obstructive Pulmonary Disease
- History of diabetes mellitus with neuropathy
- History of previous intra-articular fracture of involved extremity causing surgical fixation
- History of sickle cell trait/disease
- Previous participation in BFRT
- Any surgical procedure affecting their ability to complete all PT sessions or testing.
- History of functionally limiting arthritis in non-surgical Lower Extremity
- Prior contralateral Total Knee Arthroplasty
- Prior Total Hip Arthroplasty
- Positive pregnancy test
- Enrollment into another clinical research trial
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Flow Restriction Training Vs Standard Physical Therapy Following Total Knee Arthroplasty Prospective Intervention Study (Blood Flow Restriction Training: BFRT)
Background Blood flow restriction training (BFRT) uses a specialized tourniquet system to restrict arterial inflow and venous outflow to the limb during low-load resistance exercise. BFRT has the potential to augment strength gains for rehabilitation patients who are unable to tolerate high intensity resistance training.
Objective To determine if BFRT will accelerate the recovery of thigh muscle function and strength in post-operative TKA compared to a standard post-operative rehabilitation protocol.
Read more
Primary Outcome Measures:
Quadriceps Strength: dynamometry (hand held)
Secondary Outcomes Measures:
Patient Reported Outcomes Knee Injury and Osteoarthritis Outcome Score, Jr Veterans Rand -12 Functional Measures Timed stair ascent Four square Test 5x Sit to Stand Test
Study Design Open label randomized clinical trial with a 1:1 allocation in random sized blocks
Sample Size Based on a Pre-TKA Quadriceps Maximal Voluntary Isometric Contraction mean of 18 with a standard deviation of 8, expecting a 20% improvement of MVIC with BFRT compared to standard Physical Therapy, with an α of 0.05 and β of 0.20 (80% power), the sample size is 63 in each arm. To account for a 20% drop-out rate, a total of 75 subjects will be enrolled in each arm Study Arms Control arm: Subjects will receive American College of Sports Medicine guided-strength training Experimental: Subjects will receive BFRT strength training as part of their post-operative physical therapy program for two months during normal post-op rehab.
Read the detailed description
Background Blood flow restriction training (BFRT) uses a specialized tourniquet system to restrict arterial inflow and venous outflow to the limb during low-load resistance exercise. BFRT has the potential to augment strength gains for rehabilitation patients who are unable to tolerate high intensity resistance training.
Objective To determine if BFRT will accelerate the recovery of thigh muscle function and strength in post-operative TKA compared to a standard post-operative rehabilitation protocol.
Primary Outcome Measures:
Quadriceps Strength: dynamometry (hand held)
Secondary Outcomes Measures:
Patient Reported Outcomes Knee Injury and Osteoarthritis Outcome Score, Jr Veterans Rand -12 Functional Measures Timed stair ascent Four square Test 5x Sit to Stand Test
Study Design Open label randomized clinical trial with a 1:1 allocation in random sized blocks
Sample Size Based on a Pre-TKA Quadriceps Maximal Voluntary Isometric Contraction mean of 18 with a standard deviation of 8, expecting a 20% improvement of MVIC with BFRT compared to standard Physical Therapy, with an α of 0.05 and β of 0.20 (80% power), the sample size is 63 in each arm. To account for a 20% drop-out rate, a total of 75 subjects will be enrolled in each arm
Study Arms Control arm: Subjects will receive American College of Sports Medicine guided-strength training Experimental: Subjects will receive BFRT strength training as part of their post-operative physical therapy program for two months during normal post-op rehab.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Blood Flow Restriction Training, Standard Physical Therapy
- Keywords
- Total Knee Arthroplasty, Blood Flow Restriction Training, Quadriceps Strengthening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction TrainingProcedure or surgery
Same as Standard PT with the exception that BFRT involves placing the pressure cuff before the start of therapeutic exercises
Standard Physical TherapyProcedure or surgery
Therapeutic exercise, including but not limited to: movement re-education, balance, and functional strength training; and Manual Physical Therapy including but not limited to passive range of motion (therapist will move your knee without your help), joint mobilization, soft-tissue mobilization and static stretching
| Study group | Role | What they receive |
|---|---|---|
| Blood Flow Restriction Training | Experimental | Blood flow restriction training (BFRT) uses a specialized tourniquet system to restrict arterial inflow and venous outflow to the limb during low-load resistance exercise.
BFRT involves placing the pressure cuff before the start of therapeutic exercises.
Therapeutic exercise, including but not limited to: movement re-education, balance, and functional strength training; Manual Physical Therapy including but not limited to passive range of motion (therapist will move your knee without your help), joint mobilization, soft-tissue mobilization and static stretching Receives: Procedure: Blood Flow Restriction Training |
| Standard Physical Therapy | Active comparator | Subjects will receive American College of Sports Medicine guided-strength training Therapeutic exercise, including but not limited to: movement re-education, balance, and functional strength training; and Manual Physical Therapy including but not limited to passive range of motion (therapist will move your knee without your help), joint mobilization, soft-tissue mobilization and static stretching Receives: Procedure: Standard Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps Strength
Quadriceps Strength measured using a handheld dynamoneter
Measured: 12 weeks post-op
Secondary outcomes (6)
Knee Injury and Osteoarthritis Outcome Score, Jr,
Knee Injury and Osteoarthritis Outcome Score, Jr,
Measured: Pre-Op, 6 and 12 weeks and 12 months post-op
Veterans Rand -12
Veterans Rand -12
Measured: Pre-Op, 6 and 12 weeks and 12 months post-op
Four square Test
Subject will be asked to walk forward, sideways, backward and sideways over four squares.
Measured: Pre-Op, 6 and 12 weeks post-op
5x Sit to Stand Test
Subject will be asked to sit in a chair with back straight and feet on a flat surface positioned about shoulder width apart, arms crossed at chest and asked to stand up and sit down five times.
Measured: Pre-Op, 6 and 12 weeks and 12 months post-op
Quadriceps Strength
Quadriceps Strength measured using a handheld dynamoneter
Measured: 6 weeks post-op
Quadriceps Strength
Quadriceps Strength measured using a handheld dynamoneter
Measured: 12 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start18 Feb 2021
- Primary completion29 Dec 2021
- Study completion29 Dec 2021
Why it stopped: Several SubInvestigators have left Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norton Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Stimac, MD, Principal investigator, Norton Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366336
- Sponsor's protocol ID
- 19-N0153
- Acronym
- BFRT-TKA
- Status last verified
- Feb 2022
- First submitted
- 24 Apr 2020
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction Training Vs Standard Physical Therapy Following Total Knee Arthroplasty Prospective Intervention Study (Blood Flow Restriction Training: BFRT)
- ClinicalTrials.gov ID
- NCT04366336
- Acronym / sponsor ID
- BFRT-TKA / 19-N0153
- Conditions
- Total Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty, Blood Flow Restriction Training, Quadriceps Strengthening
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Several SubInvestigators have left Institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Norton HealthcareUniversity, hospital or other
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 29 Dec 2021 (actual)
- Study completion
- 29 Dec 2021 (actual)
- First posted
- 28 Apr 2020 (actual)
- 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.
Background Blood flow restriction training (BFRT) uses a specialized tourniquet system to restrict arterial inflow and venous outflow to the limb during low-load resistance exercise. BFRT has the potential to augment strength gains for rehabilitation patients who are unable to tolerate high intensity resistance training.
Objective To determine if BFRT will accelerate the recovery of thigh muscle function and strength in post-operative TKA compared to a standard post-operative rehabilitation protocol.
Primary Outcome Measures:
Quadriceps Strength: dynamometry (hand held)
Secondary Outcomes Measures:
Patient Reported Outcomes Knee Injury and Osteoarthritis Outcome Score, Jr Veterans Rand -12 Functional Measures Timed stair ascent Four square Test 5x Sit to Stand Test
Study Design Open label randomized clinical trial with a 1:1 allocation in random sized blocks
Sample Size Based on a Pre-TKA Quadriceps Maximal Voluntary Isometric Contraction mean of 18 with a standard deviation of 8, expecting a 20% improvement of MVIC with BFRT compared to standard Physical Therapy, with an α of 0.05 and β of 0.20 (80% power), the sample size is 63 in each arm. To account for a 20% drop-out rate, a total of 75 subjects will be enrolled in each arm Study Arms Control arm: Subjects will receive American College of Sports Medicine guided-strength training Experimental: Subjects will receive BFRT strength training as part of their post-operative physical therapy program for two months during normal post-op rehab.
Detailed description
Background Blood flow restriction training (BFRT) uses a specialized tourniquet system to restrict arterial inflow and venous outflow to the limb during low-load resistance exercise. BFRT has the potential to augment strength gains for rehabilitation patients who are unable to tolerate high intensity resistance training.
Objective To determine if BFRT will accelerate the recovery of thigh muscle function and strength in post-operative TKA compared to a standard post-operative rehabilitation protocol.
Primary Outcome Measures:
Quadriceps Strength: dynamometry (hand held)
Secondary Outcomes Measures:
Patient Reported Outcomes Knee Injury and Osteoarthritis Outcome Score, Jr Veterans Rand -12 Functional Measures Timed stair ascent Four square Test 5x Sit to Stand Test
Study Design Open label randomized clinical trial with a 1:1 allocation in random sized blocks
Sample Size Based on a Pre-TKA Quadriceps Maximal Voluntary Isometric Contraction mean of 18 with a standard deviation of 8, expecting a 20% improvement of MVIC with BFRT compared to standard Physical Therapy, with an α of 0.05 and β of 0.20 (80% power), the sample size is 63 in each arm. To account for a 20% drop-out rate, a total of 75 subjects will be enrolled in each arm
Study Arms Control arm: Subjects will receive American College of Sports Medicine guided-strength training Experimental: Subjects will receive BFRT strength training as part of their post-operative physical therapy program for two months during normal post-op rehab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood Flow Restriction Training | Experimental | Procedure: Blood Flow Restriction TrainingBlood flow restriction training (BFRT) uses a specialized tourniquet system to restrict arterial inflow and venous outflow to the limb during low-load resistance exercise. BFRT involves placing the pressure cuff before the start of therapeutic exercises. Therapeutic exercise, including but not limited to: movement re-education, balance, and functional strength training; Manual Physical Therapy including but not limited to passive range of motion (therapist will move your knee without your help), joint mobilization, soft-tissue mobilization and static stretching |
| Standard Physical Therapy | Active comparator | Procedure: Standard Physical TherapySubjects will receive American College of Sports Medicine guided-strength training Therapeutic exercise, including but not limited to: movement re-education, balance, and functional strength training; and Manual Physical Therapy including but not limited to passive range of motion (therapist will move your knee without your help), joint mobilization, soft-tissue mobilization and static stretching |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Status post primary TKA and cleared by surgeon for Physical Therapy.
- Ages 50-79 years old
- Able to participate fully in PT
- Primary cruciate retaining or posterior stabilized TKA.
- Knee Range of Motion of surgical extremity is a minimum of 5° on full extension to 90° on full flexion
Key exclusion criteria (0 listed)
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 TrainingSame as Standard PT with the exception that BFRT involves placing the pressure cuff before the start of therapeutic exercises | Procedure or surgery | Blood Flow Restriction Training |
| Standard Physical TherapyTherapeutic exercise, including but not limited to: movement re-education, balance, and functional strength training; and Manual Physical Therapy including but not limited to passive range of motion (therapist will move your knee without your help), joint mobilization, soft-tissue mobilization and static stretching | Procedure or surgery | Standard Physical Therapy |
Primary outcome
Quadriceps Strength
Time frame: 12 weeks post-op
Quadriceps Strength measured using a handheld dynamoneter
6 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score, Jr,
Time frame: Pre-Op, 6 and 12 weeks and 12 months post-op
Veterans Rand -12
Time frame: Pre-Op, 6 and 12 weeks and 12 months post-op
Four square Test
Time frame: Pre-Op, 6 and 12 weeks post-op
5x Sit to Stand Test
Time frame: Pre-Op, 6 and 12 weeks and 12 months post-op
Quadriceps Strength
Time frame: 6 weeks post-op
Quadriceps Strength
Time frame: 12 months post-op
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
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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.
Jeffrey Stimac, MD principal investigator
Norton Healthcare
1 site 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 Training and Standard Physical Therapy in people with Total Knee Arthroplasty, run by Norton Healthcare at 1 site 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 30 inclusion and 0 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: withdrawn, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 withdrawn before enrolling participants, so there are no results.
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?
Quadriceps Strength (time frame: 12 weeks post-op). 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 7 Mar 2022; AzTrials last refreshed its copy on 3 Nov 2026.