Blood Flow Restriction Exercise Study (BFR)

July 23, 2019 updated by: University of Florida

Blood Flow Restriction Exercise for Older Adults Undergoing Knee Replacement Surgery

This pilot study will investigate the effects of blood flow restriction (BFR) exercise for up to 4-6 weeks prior to total knee arthroplasty (TKA) surgery in older patients to measure clinical outcomes such as strength, lower extremity function, and pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is to test the feasibility and efficacy of a low-resistance exercise protocol with blood flow restriction (BFR) using a tourniquet in the preoperative period of patients awaiting TKA. BFR exercise is a new exercise method that has not been studied in the perioperative period. The investigators will compare our intervention to a no-exercise group up to 4 - 6 weeks prior to surgery to determine if this type of exercise is feasible in the preoperative period and if BFR exercise will improve functional, physiological, and molecular outcomes when compared to patients without exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610-3003
        • United States, Florida UF Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • are scheduled for elective TKA for osteoarthritis
  • are scheduled for unilateral joint replacement surgery only
  • are able to give consent and follow instructions
  • are willing to complete up to 15 study visits

Exclusion Criteria:

  • patients below the age of 55 years old
  • patients over the age of 80 years old
  • patients who live in a radius greater than 45 miles from the University of Florida (a feasible distance to allow for transportation to and from the clinical center for assessment visits)
  • patients with impaired cognitive function and mental disease, (e.g. diagnosis of Alzheimer's disease)
  • patients with paraplegia/extremity amputation
  • patients with end stage renal disease requiring dialysis
  • patients with uncontrolled diabetes and insulin-dependent diabetes
  • patients with uncontrolled cardiovascular disease e.g. (Classes of Heart Failure (CHF) New York Heart Association (NYHA) class 3 or higher, BP > 180/110 mmHg)
  • patients with severe pulmonary disease requiring continuous oxygen therapy
  • patients with active neoplasm
  • patients with peripheral vascular disease or deep vein thrombosis (within the last 3 years)
  • patients with structured exercise/Physical Therapy(PT)/Occupational Therapy (OT)/fitness program enrollment within 12 weeks prior to surgery and/or more than 2 hours per month on gym/fitness room exercises
  • patients with BMI greater than 40 kg/m2
  • patients with opioid use of more than 30 mg Morphine-equivalents per day
  • patients with chronic oral steroid use
  • patients with chronic anticoagulation (e.g. Plavix, Warfarin)
  • patients with planned postoperative admission to a skilled nursing/inpatient rehab facility
  • patients with ipsilateral joint disease involving hip, ankle or spine
  • neurologic or other etiology of quadriceps wasting
  • surgery within less than 4 weeks
  • patients with comorbidities that the PI judges as not suitable for the study
  • patients with a minimal mental status (MMSE) score below 24

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: NO-EX group
Subjects allocated to the No Exercise (NO-EX) group will undergo: Strength testing, Short Physical Performance Battery (SPPB), Six-minute walk (SMW), Numerical pain scale, Self-assessed function and Six-minute walk (SMW) test. Intra-op muscle biopsies.
Device: Strength testing
Test the strength of subject's lower extremity muscles on the dynamometer system
Behavioral: Short Physical Performance Battery (SPPB)
The SPPB is a timed short distance walk, repeated chair stands, and balance test that measures lower extremity function.
Behavioral: Six-minute walk (SMW)
Subjects walk back and forth along a 100-ft hallway for six minutes after instructions to complete as many laps as possible.
Behavioral: Numerical pain scale
Measure pain using an 11-point numerical pain scale.
Behavioral: Self-assessed function
Using the Late Life Function and Disability Instrument.
Procedure: Muscle biopsies
During the course of the surgery two small muscle biopsies from the quadriceps muscle of the operative leg will be collected.
Experimental: EX-BFR group
Subjects allocated to the EX-BFR group will undergo baseline strength testing, Short Physical Performance Battery (SPPB), Numerical pain scale, Six-minute walk (SMW), Self-assessed function, and determination of 1 Repetition Maximum (1-RM). Blood flow restriction exercise, Borg Category Ratio 10 (Borg CR10) scale. Intra-op muscle biopsies.
Device: Strength testing
Test the strength of subject's lower extremity muscles on the dynamometer system
Behavioral: Short Physical Performance Battery (SPPB)
The SPPB is a timed short distance walk, repeated chair stands, and balance test that measures lower extremity function.
Behavioral: Six-minute walk (SMW)
Subjects walk back and forth along a 100-ft hallway for six minutes after instructions to complete as many laps as possible.
Behavioral: Numerical pain scale
Measure pain using an 11-point numerical pain scale.
Behavioral: Self-assessed function
Using the Late Life Function and Disability Instrument.
Procedure: Muscle biopsies
During the course of the surgery two small muscle biopsies from the quadriceps muscle of the operative leg will be collected.
Device: Determination of 1 Repetition Maximum (1-RM)
Following the warm-up, subjects will attempt to complete one repetition of the leg press exercise at progressively greater resistance until a full repetition can no longer be performed. The weight of the last complete unassisted repetition will be recorded as the 1-RM.
Device: Blood flow restriction exercise
Perform lower-extremity exercises (leg press, leg extension, leg curl, and calf extension) at an intensity of 30% of 1-RM with external compression applied to the proximal thigh of each leg.
Behavioral: Borg CR10 scale
Following each exercise session, participants will provide a rating of perceived exertion (RPE) for the session according to the Borg CR10 scale.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes between the two group assessed by muscle strength
Time Frame: Changes from baseline (pre-op) up to 2 weeks post-op
Test the strength of subject's lower extremity muscles on the dynamometer system
Changes from baseline (pre-op) up to 2 weeks post-op

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes between the two group assessed by Short Physical Performance Battery (SPPB)
Time Frame: Changes from baseline (pre-op) up to 2 weeks post-op
SPPB is a validated test to measure lower extremity function a timed short distance walk, repeated chair stands, and balance test.
Changes from baseline (pre-op) up to 2 weeks post-op
Changes between the two group assessed by Six-minute walk (SMW) test
Time Frame: Changes from baseline (pre-op) up to 2 weeks post-op
SPPB is a validated test to measure lower extremity function a timed short distance walk, repeated chair stands, and balance test.
Changes from baseline (pre-op) up to 2 weeks post-op
Changes between the two group assessed by pain
Time Frame: Changes from baseline (pre-op) up to 2 weeks post-op
Measure pain using an 11-point numerical pain scale
Changes from baseline (pre-op) up to 2 weeks post-op
Changes between the two group assessed by self-assessment outcomes
Time Frame: Changes from baseline (pre-op) up to 2 weeks post-op
Assessed using the Late Life Function and Disability Instrument
Changes from baseline (pre-op) up to 2 weeks post-op
Changes between the two group assessed by biological targets on the muscle tissue
Time Frame: Up to 4 hours (end of surgery)
Analysis of the muscle tissue will focus on metabolism, inflammation, autophagy, apoptosis and other mechanisms of muscular atrophy.
Up to 4 hours (end of surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Florida Clinical and Translational Science Institute (CTSI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rene Przkora, MD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB201601042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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