Blood-Flow Restriction Exercise Following a Knee Replacement

Not Applicable

Active, not recruiting

• Conditions: Knee Arthritis; Knee Osteoarthritis; Knee Injuries
• Interventions: Other: B-FREE

• Registration Number: NCT04018638
• Lead Sponsor: Michigan Technological University

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2019-06-25
• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-07-11
• Study First Posted: 2019-07-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-12-25
• Study Completion: 2025-12-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adults with TKR Perform Home Exercise Program	B-FREE	Participants that have a total knee replacement will complete a home-based exercise program

Primary Outcome Measures

Name	Time	Method
Change in Muscle size	Change from baseline at 10 weeks	quadriceps muscle thickness
Change in Muscle strength	Change from baseline at 10 weeks	quadriceps muscle strength

Secondary Outcome Measures

Name	Time	Method
Change in Balance	Change from baseline at 10 weeks	balance assessment
Change in Walking performance	Change from baseline at 10 weeks	walking distance

Trial Locations

Locations (1)

Michigan Technological University; 🇺🇸 Houghton, Michigan, United States