CClinicalTrials.gg
CompletedNCT06928181Updated Apr 15, 2025

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

An interventional study of Blood Flow Restriction Training and Sham-BFR in Osteoarthritis in the Knee, sponsored by University Hospital, Bonn. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2025-04-15.

Sponsored by University Hospital, Bonn · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Apr 2024, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Osteoarthritis in the Knee
03

In context

Muscular Atrophy

494 studies on the registry are indexed under Muscular Atrophy; 94 are open to participants now.

This study's enrollment of 20 is below the median of 33 across 335 interventional studies indexed under Muscular Atrophy.

Browse Muscular Atrophy studies →

Lead sponsor

University Hospital, Bonn is the lead sponsor of 154 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Sham comparator
    Control

    Sham-BFR Intervention with 20mmHg

    Other: Sham-BFR

  • Experimental
    Intervention

    BFR-Intervention with 80% of the 1RM

    Other: Blood Flow Restriction Training

Interventions

  • OtherBlood 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

  • OtherSham-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.

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What researchers measure

Primary outcomes

  1. Muscle Mass

    Lean Body Mass in DEXA anaylsis

    Time frame: Three Months

  2. Postoperative Pain

    0-100 mm VAS

    Time frame: Three Months

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Study locations

1 site
  • University Hospital Bonn
    Bonn, NRW 53127, Germany
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06928181
Lead sponsor
University Hospital, Bonn
Responsible party
Alexander Franz (Dr. med., B.Sc., University Hospital, Bonn) — Principal investigator
First posted
Apr 15, 2025
Start date
Apr 1, 2024
Primary completion
Feb 20, 2025
Completion
Feb 20, 2025
Last update
Apr 15, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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