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CompletedNCT06942065ClinicalTrials.gov record

Clinical-randomized Study of the Influence of Rehabilitation Therapy Using Strength and Blood Flow Restriction Training on Muscular Fitness and Regeneration After Elective Total Knee Arthroplasty

Osteoarthritis (OA) of the Knee · Muscle Atrophy

THE QUICK READ

What this study involves

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Study type
Interventional
Phase
Not applicable
Age range
18 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
25 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The present study investigates the effects of blood flow restriction training on muscular recovery during out-patient rehabilitation after elective total knee arthroplasty

Read the full description

The present study evaluated the impact of blood flow restriction training in the context of three-week outpatient rehabilitation following TKA, in accordance with the guidelines of the German Pension Insurance System. The in-rehabilitation and post-rehabilitation muscle status, strength, knee functionality, impairments in daily life and subjective pain perception were measured.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

  • Physical Fitness for Rehabilitation
  • Primary TKA surgery
  • BMI \< 35

Exclusion Criteria:

  • Sickle Cell Anemia
  • Vascular Intervention on the lower extremities
  • Open Wounds
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Treatment, groups and participation

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Assignment
Random assignment
Masking
Double masked
Control Group

Control sham condition which performed the exercise with a fixed pressure of 20mmHg

Procedure: Sham-BFR

Blood Flow Restriction Group

This intervention groups performed training on the operated limb with a BFR pressure corresponding to 60% of the individual limb occlusion pressure

Procedure: Blood Flow Restriction Training

Sham-BFR PROCEDURE

The exercise protocol for the operated leg (with sham pressure of 20mmHg) consisted of four sets with 75 repetitions (reps) in total (1. Set: 30 reps, 2.-4. Set: 15 reps) with 30% of the individual one-repetition maximum for each exercise and were performed five times per week during the three-week outpatient rehabilitation.

Blood Flow Restriction Training PROCEDURE

The exercise protocol for the operated leg (with a BFR pressure of 60% of the LOP) consisted of four sets with 75 repetitions (reps) in total (1. Set: 30 reps, 2.-4. Set: 15 reps) with 30% of the individual one-repetition maximum for each exercise and were performed five times per week during the three-week outpatient rehabilitation.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Postoperative Pain

Time frame: Pre- to 6 weeks Post Rehabilitation

Postoperative Pain was assessed by KOOS and SF-36

Muscle Strength

Time frame: Pre- to 6 weeks Post Rehabilitation

Isometric muscle strength was measured on a DDRobotec (Dynamic Devices AG, Zurich, Switzerland), a pneumatic, computer-controlled leg press

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

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1 locations

University Hospital BonnBonn, North Rhine-Westphalia, GermanyStatus unknown

Study team and timeline

Lead sponsor
University Hospital, Bonn
Study start
Jun 1, 2023 Actual
Primary completion
Dec 31, 2024 Actual
Study completion
Jan 1, 2025 Actual
First posted
Apr 24, 2025 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

Clinical-randomized Study of the Influence of Rehabilitation Therapy Using Strength and Blood Flow Restriction Training on Muscular Fitness and Regeneration After Elective Total Knee Arthroplasty

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026