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

April 16, 2025 updated by: Alexander Franz, University Hospital, Bonn
The present study investigates the effects of blood flow restriction training on muscular recovery during out-patient rehabilitation after elective total knee arthroplasty

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Sickle Cell Anemia
  • Vascular Intervention on the lower extremities
  • Open Wounds

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control Group
Control sham condition which performed the exercise with a fixed pressure of 20mmHg
Procedure: Sham-BFR
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.
Experimental: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain
Time Frame: Pre- to 6 weeks Post Rehabilitation
Postoperative Pain was assessed by visual analoge scale (0-100mm)
Pre- to 6 weeks Post Rehabilitation
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
Pre- to 6 weeks Post Rehabilitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

April 16, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023_E

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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