Investigation of the Individual Fatigue Response During Blood Flow Restriction Training

NCT07611526 | Not Yet Recruiting

• 1 other identifier: 2026_A
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Knee Anthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Muscle Strength [1RM]

  Baseline- vs. immediately after the exercise (Pre-Post-Comparison)

Study Arms (2)

Low Load

EXPERIMENTAL

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

High Load

EXPERIMENTAL

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

Interventions

Cycling BFR DEVICE

Cycling ergometer with blood flow restriction

High Load; Low Load

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Central Study Contacts

Alexander Franz, Dr. med., B.Sc.

CONTACT

+491703750718; alexander.franz@ukbonn.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med., B.Sc.

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 28, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)