Blood-Flow Restriction Exercise Following a Knee Replacement

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04018638
• Other study ID #: MichiganTU
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 25, 2019
• Est. completion date: July 25, 2024

Study information

• Verified date: March 2023
• Source: Michigan Technological University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: July 25, 2024
• Est. primary completion date: December 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthritis
• Knee Injuries
• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• B-FREE
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.

Locations

Country	Name	City	State
United States	Michigan Technological University	Houghton	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Michigan Technological University	Blue Cross Blue Shield of Michigan Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Muscle size	quadriceps muscle thickness	Change from baseline at 10 weeks
Primary	Change in Muscle strength	quadriceps muscle strength	Change from baseline at 10 weeks
Secondary	Change in Walking performance	walking distance	Change from baseline at 10 weeks
Secondary	Change in Balance	balance assessment	Change from baseline at 10 weeks