Effects of Passive Blood-Flow-Restriction on Muscle Atrophy and Pain After Elective Total Knee Arthroplasty

Effects of Passive Blood-Flow-Restriction Training on Muscle Atrophy and Pain After Elective Total Knee Arthroplasty

This study investigated the effects of passive Blood-Flow-Restriction Training after elective Total Knee Arthroplasty Surgery on Muscle Atrophy and Postoperative Pain.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis in the Knee
• Intervention / Treatment: Other: Sham-BFR; Other: Blood Flow Restriction Training

Detailed Description

This is the first study invesigating the effects of passive Blood-Flow-Restriction Training on Muscle Atrophy and Postoperative Pain after Elective Total Knee Arthroplasty Surgery.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Bonn, NRW, Germany, 53127
      • University Hospital Bonn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The study includes all patients with a medical indication for surgical treatment of the lower extremity (total or partial knee arthroplasty) who are eligible for either inpatient or outpatient rehabilitation.
• All participating patients have signed the informed consent form for study participation as well as the data protection declaration after receiving comprehensive explanation, counseling, and information.
• All patients have consented to the surgical procedure and received medical clearance for surgery from both the orthopedic and anesthesiology departments.

Exclusion Criteria:

• Acute or chronic infections of the extremities
• Open wounds on the lower extremity
• Pregnancy and breastfeeding
• Patients who are unable to understand the patient information and study design (e.g., due to language barriers), or whose compliance is deemed insufficient by the study team

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control; Sham-BFR Intervention with 20mmHg	Other: Sham-BFR; Patients in the control group (CG) follow the same exercise protocol as those in the BFR intervention group; however, the cuff is only inflated to a minimal pressure of 20 mmHg. This pressure does not induce any relevant venous stasis, nor can any local or systemic metabolic effects be expected.
Experimental: Intervention; BFR-Intervention with 80% of the 1RM	Other: Blood Flow Restriction Training; BFR training involves the application of blood flow restriction during passive or active movement interventions to elicit an additional metabolic stimulus. The cuffs are applied as proximally as possible on the thigh, and a pressure is exerted during the movement that partially restricts venous return from the limb, resulting in venous pooling. Venous occlusion is achieved using a cuff system commonly employed in resistance training (Delfi Medical Innovations Inc., Vancouver, Canada; CE-certified). The pressure applied is individually determined at the start of each training session based on the participant's arterial occlusion pressure, measured via duplex ultrasonography. For this measurement, the participant rests in a supine position while the cuff is gradually inflated until no blood flow is detectable in the limb (i.e., occlusion pressure). For the BFR intervention, 60-80% of this occlusion pressure is subsequently applied. The exercise protocol consists of daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Mass	Lean Body Mass in DEXA anaylsis	Three Months
Postoperative Pain	0-100 mm VAS	Three Months

Collaborators and Investigators

• Sponsor: University Hospital, Bonn

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): February 20, 2025
• Study Completion (Actual): February 20, 2025

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Muscular Atrophy
• Other Study ID Numbers: 2023_A_TKA_BFR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No