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Active, Not Recruiting

NCT Number: NCT04018638

Blood-Flow Restriction Exercise Following a Knee Replacement

This study will determine the safety and efficacy of using blood-flow restriction exercise enhancement (B-FREE) to overcome persistent quadriceps muscle weakness that occurs following a total knee replacement (TKR).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Knee Injuries Arthritis Joint Diseases Knee Arthritis Knee Osteoarthritis Leg Injuries Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases Wounds and Injuries

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michigan Technological University

Houghton, Michigan, 49931, United States

About this study

This study aims to determine the safety and efficacy of using B-FREE to overcome persistent quadriceps muscle weakness that occurs following a TKR. We hypothesize that B-FREE can provide a safe training stimulus and offer a home-based program to restore quadriceps muscle strength and improve functional mobility. Specifically, subjects that have a TKR will perform B-FREE at home (light weights with resistance bands and walking) 3x/wk for 10 weeks. Quadriceps muscle strength, balance, and functional mobility will be assessed before and after the program. Changes in these variables will be compared to healthy age-matched uninjured controls.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 40-75 years of age
  • Have had a unilateral TKA > 6 months prior to participation (Arm 1)
  • No previous history of knee injury/surgery (Arm 2)

Exclusion criteria

  • Are a smoker
  • Have diabetes
  • Have suffered a heart attack or stroke
  • Have any cardiopulmonary disorders (hypertension discussed below)
  • Have been diagnosed with any neurological disorders
  • Have any implanted devices such as but not limited to a pacemaker or pain pump
  • Uncontrolled (not medicated) Stage 1 hypertension or Stage 2 hypertension

Treatment and study plan

B-FREE

Other

Blood flow-restriction exercise enhancement (B-FREE) will be performed at home 3x/wk for 10 weeks. A blood pressure cuff will be inflated to partially occlude blood to the limb during light weight exercises involving knee extension, body weight squats, and walking.

Primary outcomes

  1. Change in Muscle size

    Time frame: Change from baseline at 10 weeks

    quadriceps muscle thickness

  2. Change in Muscle strength

    Time frame: Change from baseline at 10 weeks

    quadriceps muscle strength

Secondary outcomes

  1. Change in Walking performance

    Time frame: Change from baseline at 10 weeks

    walking distance

  2. Change in Balance

    Time frame: Change from baseline at 10 weeks

    balance assessment

Sponsors and collaborators

Lead sponsor

Michigan Technological University

Other

Collaborators

  • Blue Cross Blue Shield of Michigan Foundation

Registry information

Official study title

B-FREE in the UP! Improving Recovery After a Knee Replacement With Blood-Flow Restriction Exercise Enhancement

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Jul 12, 2019
Registry last updated
Jul 15, 2026

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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