Blood Flow Restriction Exercise Study

NCT02868021 | Completed DMC

• 1 other identifier: IRB201601042
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Elderly; Exercise

Outcome Measures

Primary Outcomes (1)

• Changes between the two group assessed by muscle strength

  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 Outcomes (5)

• Changes between the two group assessed by Short Physical Performance Battery (SPPB)

  Changes from baseline (pre-op) up to 2 weeks post-op

• Changes between the two group assessed by Six-minute walk (SMW) test

  Changes from baseline (pre-op) up to 2 weeks post-op

• Changes between the two group assessed by pain

  Changes from baseline (pre-op) up to 2 weeks post-op

• Changes between the two group assessed by self-assessment outcomes

  Changes from baseline (pre-op) up to 2 weeks post-op

• Changes between the two group assessed by biological targets on the muscle tissue

  Up to 4 hours (end of surgery)

Study Arms (2)

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.

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.

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

Interventions

Strength testing DEVICE

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

EX-BFR group; NO-EX group

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.

EX-BFR group; NO-EX group

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.

EX-BFR group; NO-EX group

Numerical pain scale BEHAVIORAL

Measure pain using an 11-point numerical pain scale.

EX-BFR group; NO-EX group

Self-assessed function BEHAVIORAL

Using the Late Life Function and Disability Instrument.

EX-BFR group; NO-EX group

Muscle biopsies PROCEDURE

During the course of the surgery two small muscle biopsies from the quadriceps muscle of the operative leg will be collected.

EX-BFR group; NO-EX group

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.

EX-BFR group

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.

EX-BFR group

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.

EX-BFR group

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• University of Florida Clinical and Translational Science Institute (CTSI): collaborator

Study Sites (1)

United States, Florida UF Health

Gainesville, Florida, 32610-3003, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Interventions

Walking; Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Rene Przkora, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 16, 2016
• Study Start: December 12, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: July 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)