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Blood Flow Restriction Exercise Study (BFR)

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strength testing
Short Physical Performance Battery (SPPB)
Six-minute walk (SMW)
Numerical pain scale
Self-assessed function
Muscle biopsies
Determination of 1 Repetition Maximum (1-RM)
Blood flow restriction exercise
Borg CR10 scale
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Osteoarthritis, Knee focused on measuring Elderly, Exercise

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • United States, Florida UF Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

NO-EX group

EX-BFR group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes between the two group assessed by muscle strength
Test the strength of subject's lower extremity muscles on the dynamometer system

Secondary Outcome Measures

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.
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.
Changes between the two group assessed by pain
Measure pain using an 11-point numerical pain scale
Changes between the two group assessed by self-assessment outcomes
Assessed using the Late Life Function and Disability Instrument
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.

Full Information

First Posted
August 11, 2016
Last Updated
July 23, 2019
Sponsor
University of Florida
Collaborators
University of Florida Clinical and Translational Science Institute (CTSI)
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1. Study Identification

Unique Protocol Identification Number
NCT02868021
Brief Title
Blood Flow Restriction Exercise Study
Acronym
BFR
Official Title
Blood Flow Restriction Exercise for Older Adults Undergoing Knee Replacement Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 12, 2016 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
University of Florida Clinical and Translational Science Institute (CTSI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Elderly, Exercise

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NO-EX group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
EX-BFR group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Strength testing
Intervention Description
Test the strength of subject's lower extremity muscles on the dynamometer system
Intervention Type
Behavioral
Intervention Name(s)
Short Physical Performance Battery (SPPB)
Intervention Description
The SPPB is a timed short distance walk, repeated chair stands, and balance test that measures lower extremity function.
Intervention Type
Behavioral
Intervention Name(s)
Six-minute walk (SMW)
Intervention Description
Subjects walk back and forth along a 100-ft hallway for six minutes after instructions to complete as many laps as possible.
Intervention Type
Behavioral
Intervention Name(s)
Numerical pain scale
Intervention Description
Measure pain using an 11-point numerical pain scale.
Intervention Type
Behavioral
Intervention Name(s)
Self-assessed function
Intervention Description
Using the Late Life Function and Disability Instrument.
Intervention Type
Procedure
Intervention Name(s)
Muscle biopsies
Intervention Description
During the course of the surgery two small muscle biopsies from the quadriceps muscle of the operative leg will be collected.
Intervention Type
Device
Intervention Name(s)
Determination of 1 Repetition Maximum (1-RM)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Blood flow restriction exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Borg CR10 scale
Intervention Description
Following each exercise session, participants will provide a rating of perceived exertion (RPE) for the session according to the Borg CR10 scale.
Primary Outcome Measure Information:
Title
Changes between the two group assessed by muscle strength
Description
Test the strength of subject's lower extremity muscles on the dynamometer system
Time Frame
Changes from baseline (pre-op) up to 2 weeks post-op
Secondary Outcome Measure Information:
Title
Changes between the two group assessed by Short Physical Performance Battery (SPPB)
Description
SPPB is a validated test to measure lower extremity function a timed short distance walk, repeated chair stands, and balance test.
Time Frame
Changes from baseline (pre-op) up to 2 weeks post-op
Title
Changes between the two group assessed by Six-minute walk (SMW) test
Description
SPPB is a validated test to measure lower extremity function a timed short distance walk, repeated chair stands, and balance test.
Time Frame
Changes from baseline (pre-op) up to 2 weeks post-op
Title
Changes between the two group assessed by pain
Description
Measure pain using an 11-point numerical pain scale
Time Frame
Changes from baseline (pre-op) up to 2 weeks post-op
Title
Changes between the two group assessed by self-assessment outcomes
Description
Assessed using the Late Life Function and Disability Instrument
Time Frame
Changes from baseline (pre-op) up to 2 weeks post-op
Title
Changes between the two group assessed by biological targets on the muscle tissue
Description
Analysis of the muscle tissue will focus on metabolism, inflammation, autophagy, apoptosis and other mechanisms of muscular atrophy.
Time Frame
Up to 4 hours (end of surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rene Przkora, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
United States, Florida UF Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-3003
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Blood Flow Restriction Exercise Study

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