Knee InjuriesNCT04018638
Blood-Flow Restriction Exercise Following a Knee Replacement
A study testing B-FREE in people with Knee Injuries and Knee Osteoarthritis, run by Michigan Technological University at 1 site in United States.
Trial summary
This study will determine the safety and efficacy of using blood-flow restriction exercise enhancement (B-FREE) to overcome persistent quadriceps muscle weakness that occurs following a total knee replacement (TKR). Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Injuries, Knee Osteoarthritis, Knee Arthritis
- What is being tested?
- B-FREE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2019to 25 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40-75 years of age
- Have had a unilateral TKA > 6 months prior to participation (Arm 1)
- No previous history of knee injury/surgery (Arm 2)
Who cannot join
- Are a smoker
- Have diabetes
- Have suffered a heart attack or stroke
- Have any cardiopulmonary disorders (hypertension discussed below)
- Have been diagnosed with any neurological disorders
- Have any implanted devices such as but not limited to a pacemaker or pain pump
- Uncontrolled (not medicated) Stage 1 hypertension or Stage 2 hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Technological University
Houghton, Michigan, 49931
About this study
Official title: B-FREE in the UP! Improving Recovery After a Knee Replacement With Blood-Flow Restriction Exercise Enhancement
This study will determine the safety and efficacy of using blood-flow restriction exercise enhancement (B-FREE) to overcome persistent quadriceps muscle weakness that occurs following a total knee replacement (TKR).
Read the detailed description
This study aims to determine the safety and efficacy of using B-FREE to overcome persistent quadriceps muscle weakness that occurs following a TKR. We hypothesize that B-FREE can provide a safe training stimulus and offer a home-based program to restore quadriceps muscle strength and improve functional mobility. Specifically, subjects that have a TKR will perform B-FREE at home (light weights with resistance bands and walking) 3x/wk for 10 weeks. Quadriceps muscle strength, balance, and functional mobility will be assessed before and after the program. Changes in these variables will be compared to healthy age-matched uninjured controls.
- Conditions
- Knee Injuries, Knee Osteoarthritis, Knee Arthritis
- Being tested
- B-FREE
- Medical subject headings
- Knee Injuries, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-FREEOther
Blood flow-restriction exercise enhancement (B-FREE) will be performed at home 3x/wk for 10 weeks. A blood pressure cuff will be inflated to partially occlude blood to the limb during light weight exercises involving knee extension, body weight squats, and walking.
| Study group | Role | What they receive |
|---|---|---|
| Adults with TKR Perform Home Exercise Program | Experimental | Participants that have a total knee replacement will complete a home-based exercise program Receives: Other: B-FREE |
| Healthy Controls Only | No intervention | Participants that have no history of knee joint dysfunction will serve as age-matched uninjured controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle size
quadriceps muscle thickness
Measured: Change from baseline at 10 weeks
Change in Muscle strength
quadriceps muscle strength
Measured: Change from baseline at 10 weeks
Secondary outcomes (2)
Change in Walking performance
walking distance
Measured: Change from baseline at 10 weeks
Change in Balance
balance assessment
Measured: Change from baseline at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start25 Jun 2019
- Primary completion25 Dec 2027 (estimated)
- Study completion25 Dec 2027 (estimated)
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan Technological University
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Responsible party
- Sponsor
- Investigators
- Steven Elmer, Principal investigator, Michigan Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018638
- Sponsor's protocol ID
- MichiganTU
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2019
- Last updated
- 15 Jul 2026
- 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 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B-FREE in the UP! Improving Recovery After a Knee Replacement With Blood-Flow Restriction Exercise Enhancement
- ClinicalTrials.gov ID
- NCT04018638
- Acronym / sponsor ID
- MichiganTU
- Conditions
- Knee Injuries, Knee Osteoarthritis, Knee Arthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Michigan Technological UniversityUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 25 Dec 2027 (estimated)
- Study completion
- 25 Dec 2027 (estimated)
- First posted
- 12 Jul 2019 (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.
This study will determine the safety and efficacy of using blood-flow restriction exercise enhancement (B-FREE) to overcome persistent quadriceps muscle weakness that occurs following a total knee replacement (TKR).
Detailed description
This study aims to determine the safety and efficacy of using B-FREE to overcome persistent quadriceps muscle weakness that occurs following a TKR. We hypothesize that B-FREE can provide a safe training stimulus and offer a home-based program to restore quadriceps muscle strength and improve functional mobility. Specifically, subjects that have a TKR will perform B-FREE at home (light weights with resistance bands and walking) 3x/wk for 10 weeks. Quadriceps muscle strength, balance, and functional mobility will be assessed before and after the program. Changes in these variables will be compared to healthy age-matched uninjured controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults with TKR Perform Home Exercise Program | Experimental | Other: B-FREEParticipants that have a total knee replacement will complete a home-based exercise program |
| Healthy Controls Only | No intervention | –Participants that have no history of knee joint dysfunction will serve as age-matched uninjured controls |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 40-75 years of age
- Have had a unilateral TKA > 6 months prior to participation (Arm 1)
- No previous history of knee injury/surgery (Arm 2)
Key exclusion criteria (7 listed)
- Are a smoker
- Have diabetes
- Have suffered a heart attack or stroke
- Have any cardiopulmonary disorders (hypertension discussed below)
- Have been diagnosed with any neurological disorders
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 |
|---|---|---|
| B-FREEBlood flow-restriction exercise enhancement (B-FREE) will be performed at home 3x/wk for 10 weeks. A blood pressure cuff will be inflated to partially occlude blood to the limb during light weight exercises involving knee extension, body weight squats, and walking. | Other | Adults with TKR Perform Home Exercise Program |
Primary outcome
Change in Muscle size
Time frame: Change from baseline at 10 weeks
quadriceps muscle thickness
Change in Muscle strength
Time frame: Change from baseline at 10 weeks
quadriceps muscle strength
2 secondary outcomes
Change in Walking performance
Time frame: Change from baseline at 10 weeks
Change in Balance
Time frame: Change from baseline at 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- 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.
Steven Elmer principal investigator
Michigan Technological University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-FREE in people with Knee Injuries and Knee Osteoarthritis, run by Michigan Technological University 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 3 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Muscle size (time frame: Change from baseline at 10 weeks). The study lists 2 primary outcomes in all. 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 15 Jul 2026; AzTrials last refreshed its copy on 29 Oct 2026.