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Completed

NCT Number: NCT02868021

Blood Flow Restriction Exercise Study

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

United States, Florida UF Health

Gainesville, Florida, 32610-3003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strength testing

Device

Test the strength of subject's lower extremity muscles on the dynamometer system

Short Physical Performance Battery (SPPB)

Behavioral

The SPPB is a timed short distance walk, repeated chair stands, and balance test that measures lower extremity function.

Six-minute walk (SMW)

Behavioral

Subjects walk back and forth along a 100-ft hallway for six minutes after instructions to complete as many laps as possible.

Numerical pain scale

Behavioral

Measure pain using an 11-point numerical pain scale.

Self-assessed function

Behavioral

Using the Late Life Function and Disability Instrument.

Muscle biopsies

Procedure

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 exercise

Device

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 scale

Behavioral

Following each exercise session, participants will provide a rating of perceived exertion (RPE) for the session according to the Borg CR10 scale.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Blood Flow Restriction Exercise for Older Adults Undergoing Knee Replacement Surgery

Acronym: BFR

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 16, 2016
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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