Anterior Cruciate Ligament InjuriesNCT05245864
Blood Flow Restriction Training in ACL Surgery
A study testing blood flow restriction in people with Anterior Cruciate Ligament Injuries, run by University of Arkansas at 1 site in United States.
Trial summary
This will be a randomized pilot study to determine the effectiveness of Personalized Blood Flow Restriction (PBFR) technique in conjunction with prescribed physical therapy (PT) in a cohort of anterior cruciate ligament (ACL) reconstruction subjects Read more about this study
- Who is it for?
- Ages 18 to 34 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- blood flow restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2022to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 34 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women, ages 18-34 years.
- Scheduled to undergo elective ACL surgery at UAMS.
- Capable of providing informed consent.
- Willing to exercise with BFR.
- COVID-19 negative or asymptomatic.
Who cannot join
- Any surgical indication other than ACL repair.
- Body mass index >40.
- Pregnant female.
- Neurological, musculoskeletal, or other disorder that would preclude them from completing the exercise training intervention and all performance tests.
- Hypertension as evidenced by systolic BP >150 at rest OR diastolic BP >85 at rest.
- Heart failure as evidenced by use of prescription diuretics.
Show all 16Show fewer
- History of atrial fibrillation.
- Oxygen saturation <95% on room air at rest.
- Any other medical condition that would interfere with testing or increase one's risk of complications during exercise.
- Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
- Compromised vascular circulation in the legs (e.g. peripheral vascular disease).
- History of deep vein thrombosis.
- Varicose veins in the legs.
- Known Sickle cell disease or trait.
- Unwilling to avoid using protein or amino-acid supplements during participation.
- Unwilling to avoid using BFR during prescribed post-operative physical therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Blood Flow Restriction + Progressive Resistance Functional Training to Improve Functional Outcomes After Anterior Cruciate Ligament Reconstruction
This will be a randomized pilot study to determine the effectiveness of Personalized Blood Flow Restriction (PBFR) technique in conjunction with prescribed physical therapy (PT) in a cohort of anterior cruciate ligament (ACL) reconstruction subjects
Read the detailed description
This will be a randomized pilot study to determine the effectiveness of Personalized Blood Flow Restriction (PBFR) technique in conjunction with prescribed physical therapy (PT) in a cohort of anterior cruciate ligament (ACL) reconstruction subjects. Both groups of subjects will undergo unilateral ACL reconstruction at University of Arkansas for Medical Sciences (UAMS), followed by prescribed PT at the UAMS Orthopedic Clinic at Colonel Glenn.
Up to 25 subjects will be enrolled. Half are randomized to the BFR group with the other will perform PT without BFR.
Data collection will occur at four approximate occasions: pre-surgery, 8-weeks postop, 12-weeks postop, and 16-weeks postop.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- blood flow restriction, physical therapy standard of care
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood flow restrictionOther
Blood flow to the legs will be mostly restricted temporarily during physical therapy exercises for the initial several weeks of physical therapy.
physical therapy standard of careOther
the current standard of care after surgery for ACL repair.
| Study group | Role | What they receive |
|---|---|---|
| physical therapy with blood flow restriction | Experimental | Not described Receives: Other: blood flow restriction |
| physical therapy without blood flow restriction | Other | Standard of care. Receives: Other: physical therapy standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Voluntary Contraction
Max torque produced in newton meter per second during an isometric contraction
Measured: 16-weeks post-surgery
ACL Repair Range of Motion
Measured at the knee, therefore, the degree to which the lower limb can move around knee joint in relation to the upper limb.
Measured: from enrollment to the end of treatment at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start18 Apr 2022
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Why it stopped: Difficulty recruiting subjects; funding not renewed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anterior Cruciate Ligament 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arny A Ferrando, Ph.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245864
- Sponsor's protocol ID
- 261865
- Status last verified
- Mar 2023
- First submitted
- 26 Jan 2022
- Last updated
- 9 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Blood Flow Restriction + Progressive Resistance Functional Training to Improve Functional Outcomes After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT05245864
- Acronym / sponsor ID
- 261865
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting subjects; funding not renewed.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Posted 9 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a randomized pilot study to determine the effectiveness of Personalized Blood Flow Restriction (PBFR) technique in conjunction with prescribed physical therapy (PT) in a cohort of anterior cruciate ligament (ACL) reconstruction subjects
Detailed description
This will be a randomized pilot study to determine the effectiveness of Personalized Blood Flow Restriction (PBFR) technique in conjunction with prescribed physical therapy (PT) in a cohort of anterior cruciate ligament (ACL) reconstruction subjects. Both groups of subjects will undergo unilateral ACL reconstruction at University of Arkansas for Medical Sciences (UAMS), followed by prescribed PT at the UAMS Orthopedic Clinic at Colonel Glenn.
Up to 25 subjects will be enrolled. Half are randomized to the BFR group with the other will perform PT without BFR.
Data collection will occur at four approximate occasions: pre-surgery, 8-weeks postop, 12-weeks postop, and 16-weeks postop.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physical therapy with blood flow restriction | Experimental | Other: blood flow restriction |
| physical therapy without blood flow restriction | Other | Other: physical therapy standard of careStandard of care. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women, ages 18-34 years.
- Scheduled to undergo elective ACL surgery at UAMS.
- Capable of providing informed consent.
- Willing to exercise with BFR.
- COVID-19 negative or asymptomatic.
Key exclusion criteria (16 listed)
- Any surgical indication other than ACL repair.
- Body mass index >40.
- Pregnant female.
- Neurological, musculoskeletal, or other disorder that would preclude them from completing the exercise training intervention and all performance tests.
- Hypertension as evidenced by systolic BP >150 at rest OR diastolic BP >85 at rest.
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 restrictionBlood flow to the legs will be mostly restricted temporarily during physical therapy exercises for the initial several weeks of physical therapy. | Other | physical therapy with blood flow restriction |
| physical therapy standard of carethe current standard of care after surgery for ACL repair. | Other | physical therapy without blood flow restriction |
Primary outcome
Maximal Voluntary Contraction
Time frame: 16-weeks post-surgery
Max torque produced in newton meter per second during an isometric contraction
ACL Repair Range of Motion
Time frame: from enrollment to the end of treatment at 16 weeks
Measured at the knee, therefore, the degree to which the lower limb can move around knee joint in relation to the upper limb.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Arny A Ferrando, Ph.D. principal investigator
University of Arkansas
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 in people with Anterior Cruciate Ligament Injuries, run by University of Arkansas 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 5 inclusion and 16 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 9 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximal Voluntary Contraction (time frame: 16-weeks post-surgery). 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 9 Oct 2024.