Osteoarthritis in the Knee
Conditions
Brief summary
This study investigated the effects of passive Blood-Flow-Restriction Training after elective Total Knee Arthroplasty Surgery on Muscle Atrophy and Postoperative Pain.
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.
Interventions
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
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Mass | Three Months | Lean Body Mass in DEXA anaylsis |
| Postoperative Pain | Three Months | 0-100 mm VAS |
Countries
Germany