Osteoarthritis, KneeBFRNCT02868021
Blood Flow Restriction Exercise Study
A study testing Strength testing, Short Physical Performance Battery (SPPB) and Six-minute walk (SMW) in people with Osteoarthritis, Knee, run by University of Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Strength testing, Short Physical Performance Battery (SPPB) and Six-minute walk (SMW)
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2016to 1 Aug 2018
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
United States, Florida UF Health
Gainesville, Florida, 32610-3003
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Strength testing, Short Physical Performance Battery (SPPB), Six-minute walk (SMW), Numerical pain scale, Self-assessed function
- Keywords
- Elderly, Exercise
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength testingDevice
Test the strength of subject's lower extremity muscles on the dynamometer system
Short Physical Performance Battery (SPPB)Behavioural
The SPPB is a timed short distance walk, repeated chair stands, and balance test that measures lower extremity function.
Six-minute walk (SMW)Behavioural
Subjects walk back and forth along a 100-ft hallway for six minutes after instructions to complete as many laps as possible.
Numerical pain scaleBehavioural
Measure pain using an 11-point numerical pain scale.
Self-assessed functionBehavioural
Using the Late Life Function and Disability Instrument.
Muscle biopsiesProcedure or surgery
During the course of the surgery two small muscle biopsies from the quadriceps muscle of the operative leg will be collected.
Determination of 1 Repetition Maximum (1-RM)Device
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.
Blood flow restriction exerciseDevice
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.
Borg CR10 scaleBehavioural
Following each exercise session, participants will provide a rating of perceived exertion (RPE) for the session according to the Borg CR10 scale.
| Study group | Role | What they receive |
|---|---|---|
| NO-EX group | Placebo comparator | 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. Receives: Device: Strength testing; Behavioral: Short Physical Performance Battery (SPPB); Behavioral: Six-minute walk (SMW); Behavioral: Numerical pain scale; Behavioral: Self-assessed function; Procedure: Muscle biopsies |
| EX-BFR group | Experimental | 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. Receives: Device: Strength testing; Behavioral: Short Physical Performance Battery (SPPB); Behavioral: Six-minute walk (SMW); Behavioral: Numerical pain scale; Behavioral: Self-assessed function; Procedure: Muscle biopsies; Device: Determination of 1 Repetition Maximum (1-RM); Device: Blood flow restriction exercise; Behavioral: Borg CR10 scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes between the two group assessed by muscle strength
Test the strength of subject's lower extremity muscles on the dynamometer system
Measured: Changes from baseline (pre-op) up to 2 weeks post-op
Secondary outcomes (5)
Changes between the two group assessed by Short Physical Performance Battery (SPPB)
SPPB is a validated test to measure lower extremity function a timed short distance walk, repeated chair stands, and balance test.
Measured: Changes from baseline (pre-op) up to 2 weeks post-op
Changes between the two group assessed by Six-minute walk (SMW) test
SPPB is a validated test to measure lower extremity function a timed short distance walk, repeated chair stands, and balance test.
Measured: Changes from baseline (pre-op) up to 2 weeks post-op
Changes between the two group assessed by pain
Measure pain using an 11-point numerical pain scale
Measured: Changes from baseline (pre-op) up to 2 weeks post-op
Changes between the two group assessed by self-assessment outcomes
Assessed using the Late Life Function and Disability Instrument
Measured: Changes from baseline (pre-op) up to 2 weeks post-op
Changes between the two group assessed by biological targets on the muscle tissue
Analysis of the muscle tissue will focus on metabolism, inflammation, autophagy, apoptosis and other mechanisms of muscular atrophy.
Measured: Up to 4 hours (end of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study start12 Dec 2016
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rene Przkora, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868021
- Sponsor's protocol ID
- IRB201601042
- Acronym
- BFR
- Status last verified
- Jul 2019
- First submitted
- 11 Aug 2016
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction Exercise for Older Adults Undergoing Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT02868021
- Acronym / sponsor ID
- BFR / IRB201601042
- Conditions
- Osteoarthritis, Knee
- Keywords
- Elderly, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 16 Aug 2016 (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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NO-EX group | Placebo comparator | Device: Strength testing, Behavioral: Short Physical Performance Battery (SPPB), Behavioral: Six-minute walk (SMW), Behavioral: Numerical pain scale, Behavioral: Self-assessed function, Procedure: Muscle biopsiesSubjects 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. |
| EX-BFR group | Experimental | Device: Strength testing, Behavioral: Short Physical Performance Battery (SPPB), Behavioral: Six-minute walk (SMW), Behavioral: Numerical pain scale, Behavioral: Self-assessed function, Procedure: Muscle biopsies, Device: Determination of 1 Repetition Maximum (1-RM), Device: Blood flow restriction exercise, Behavioral: Borg CR10 scaleSubjects 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. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (22 listed)
- 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
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 |
|---|---|---|
| Strength testingTest the strength of subject's lower extremity muscles on the dynamometer system | Device | EX-BFR group, NO-EX group |
| Short Physical Performance Battery (SPPB)The SPPB is a timed short distance walk, repeated chair stands, and balance test that measures lower extremity function. | Behavioural | EX-BFR group, NO-EX group |
| 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. | Behavioural | EX-BFR group, NO-EX group |
| Numerical pain scaleMeasure pain using an 11-point numerical pain scale. | Behavioural | EX-BFR group, NO-EX group |
| Self-assessed functionUsing the Late Life Function and Disability Instrument. | Behavioural | EX-BFR group, NO-EX group |
| Muscle biopsiesDuring the course of the surgery two small muscle biopsies from the quadriceps muscle of the operative leg will be collected. | Procedure or surgery | EX-BFR group, NO-EX group |
| 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 | EX-BFR group |
| Blood flow restriction exercisePerform 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. | Device | EX-BFR group |
| Borg CR10 scaleFollowing each exercise session, participants will provide a rating of perceived exertion (RPE) for the session according to the Borg CR10 scale. | Behavioural | EX-BFR group |
Primary outcome
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
5 secondary outcomes
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
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
Changes between the two group assessed by pain
Time frame: 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
Changes between the two group assessed by biological targets on the muscle tissue
Time frame: Up to 4 hours (end of surgery)
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 24 Jul 2019.
- 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.
Rene Przkora, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength testing, Short Physical Performance Battery (SPPB) and Six-minute walk (SMW) in people with Osteoarthritis, Knee, run by University of Florida 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 4 inclusion and 22 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 24 Jul 2019. 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. Some participants in this study may receive a placebo. 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?
Changes between the two group assessed by muscle strength (time frame: Changes from baseline (pre-op) up to 2 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 24 Jul 2019.