Blood-Flow Restriction Exercise Following a Knee Replacement
B-FREE in the UP! Improving Recovery After a Knee Replacement With Blood-Flow Restriction Exercise Enhancement
1 other identifier
interventional
30
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 25, 2019
CompletedFirst Submitted
Initial submission to the registry
July 10, 2019
CompletedFirst Posted
Study publicly available on registry
July 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 25, 2025
CompletedDecember 11, 2024
December 1, 2024
6.5 years
July 10, 2019
December 6, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Muscle size
quadriceps muscle thickness
Change from baseline at 10 weeks
Change in Muscle strength
quadriceps muscle strength
Change from baseline at 10 weeks
Secondary Outcomes (2)
Change in Walking performance
Change from baseline at 10 weeks
Change in Balance
Change from baseline at 10 weeks
Study Arms (2)
Adults with TKR Perform Home Exercise Program
EXPERIMENTALParticipants that have a total knee replacement will complete a home-based exercise program
Healthy Controls Only
NO INTERVENTIONParticipants that have no history of knee joint dysfunction will serve as age-matched uninjured controls
Interventions
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.
Eligibility Criteria
You may qualify if:
- years of age
- Have had a unilateral TKA \> 6 months prior to participation (Arm 1)
- No previous history of knee injury/surgery (Arm 2)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Michigan Technological University
Houghton, Michigan, 49931, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Elmer
Michigan Technological University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2019
First Posted
July 12, 2019
Study Start
June 25, 2019
Primary Completion
December 25, 2025
Study Completion
December 25, 2025
Last Updated
December 11, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share