Investigation of the Individual Fatigue Response During Blood Flow Restriction Training

Investigation of the Individual Fatigue Response During Blood Flow Restriction Training on a Cycle Ergometer Following Orthopedic Surgical Interventions

The aim of the present pilot study is to investigate the feasibility of an exercise pressure response approach for assessing physiological strain during BFR training in a clinically supervised setting. Patients undergoing rehabilitation following total knee arthroplasty (TKA) will be included. The results are intended to contribute to an improved evaluation of load management during BFR training.

Study Overview

• Status: Not yet recruiting
• Conditions: Total Knee Anthroplasty
• Intervention / Treatment: Device: Cycling BFR

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

Contacts and Locations

• Study Contact: Name: Alexander Franz, Dr. med., B.Sc.; Phone Number: +491703750718; Email: alexander.franz@ukbonn.de

Study Locations

• Germany
  • North Rhine-Westphalia
    • Bonn, North Rhine-Westphalia, Germany, 53127
      • University Hospital Bonn
      • Contact: Alexander Franz, Dr. med., B.Sc.; Phone Number: +491703750718; Email: alexander.franz@ukbonn.de

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Elective TKA caused by osteoarthritis of the knee
• Ability to perform cycling exercise
• Participant of the Rehab center

Exclusion Criteria:

• Open Wounds
• Iatrogenic Vessel Changes (e.g. Bypasses, Stenting)
• Sickle Cell Anemia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Load; Low Load (LL-BFR) The first group will perform cycle ergometer training with BFR at a low individual intensity (40% of heart rate reserve [HRR]) as the first session. One week later, the patients will complete the second exercise session using the protocol of the "HL-BFR" group.	Device: Cycling BFR; Cycling ergometer with blood flow restriction
Experimental: High Load; High Load (HL-BFR) The second group will perform cycle ergometer training with BFR at a higher individual intensity (60% of heart rate reserve [HRR]) as the first session. One week later, the patients will complete the second exercise session using the protocol of the "LL-BFR" group.	Device: Cycling BFR; Cycling ergometer with blood flow restriction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Pressure Response	Arterial Pulsation Pressure (mmHg) Assessed Continuously During Blood Flow Restriction Training	Baseline, continuous analysis throughout the entire training session until immediately after it ends (post-workout)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Strength [1RM]	Quadriceps Isometric Maximal Strength Assessed by Instrumented Leg Press Dynamometry	Baseline- vs. immediately after the exercise (Pre-Post-Comparison)

Collaborators and Investigators

• Sponsor: University Hospital, Bonn

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2026_A

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