- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07259356
Feasibility and Safety of Blood-Flow-Restriction Training in Patients With Hemophilia
November 26, 2025 updated by: Alexander Franz, University Hospital, Bonn
Effect of Blood Flow Restriction Training on the Subjective Perception of Pain in Hemophilic Arthropathy of the Knee Joint
In the course of a cross-over study design, 12 patients with hemophilic arthropathy will perform a training load on the knee extensor muscles.
The subjects will each perform one intervention with blood flow restriction and one with a Sham-BFR intervention.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
12
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
-
-
North Rhine-Westphalia
-
Bonn, North Rhine-Westphalia, 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:
- patients with haemophilia
- Ability for an exercise intervention
Exclusion Criteria:
- Sickle Cell Anemia
- Intravascular stents/bypasses
- Open Wounds/Infections of the lower extremity
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: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Condition
Sham-BFR Leg Press Exercise
|
Sham-BFR Exercise (20mmHg) while Leg Press Exercise (4 Sets, All out)
|
|
Experimental: Intervention Condition
BFR Leg Press Exercise
|
BFR Exercise (50% of the LOP) while Leg Press Exercise (4 Sets, All out)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain threshold
Time Frame: Pre- (Baseline, before Exercise) to immediately Post-Intervention (after the exercise training intervention) and 24 hours after intervention
|
Pain threshold measurement (PTT): The test determines the amount of pressure (in kg) over a given area in which a steadily increasing nonpainful pressure stimulus turns into a painful pressure sensation.
|
Pre- (Baseline, before Exercise) to immediately Post-Intervention (after the exercise training intervention) and 24 hours after intervention
|
|
Quality of Life Score
Time Frame: Pre- (Baseline, before Exercise) to immediately Post-Intervention (after the exercise training intervention) and 24 hours after intervention
|
Hemophilia Joint Health Score
|
Pre- (Baseline, before Exercise) to immediately Post-Intervention (after the exercise training intervention) and 24 hours after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
August 1, 2024
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
March 1, 2026
Study Registration Dates
First Submitted
May 13, 2025
First Submitted That Met QC Criteria
November 26, 2025
First Posted (Actual)
December 2, 2025
Study Record Updates
Last Update Posted (Actual)
December 2, 2025
Last Update Submitted That Met QC Criteria
November 26, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024_H
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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