HemophiliaNCT07259356
Feasibility and Safety of Blood-Flow-Restriction Training in Patients With Hemophilia
A study testing BFR Exercise (50% of the LOP) while Leg Press Exercise (4 Sets, All out) in people with Hemophilia, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemophilia
- What is being tested?
- BFR Exercise (50% of the LOP) while Leg Press Exercise (4 Sets, All out)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2024to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with haemophilia
- Ability for an exercise intervention
Who cannot join
- Sickle Cell Anemia
- Intravascular stents/bypasses
- Open Wounds/Infections of the lower extremity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Hemophilia
- Being tested
- Control, BFR Exercise (50% of the LOP) while Leg Press Exercise (4 Sets, All out)
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDevice
Sham-BFR Exercise (20mmHg) while Leg Press Exercise (4 Sets, All out)
BFR Exercise (50% of the LOP) while Leg Press Exercise (4 Sets, All out)Device
BFR Exercise (50% of the LOP) while Leg Press Exercise (4 Sets, All out)
| Study group | Role | What they receive |
|---|---|---|
| Control Condition | Active comparator | Sham-BFR Leg Press Exercise Receives: Device: Control |
| Intervention Condition | Experimental | BFR Leg Press Exercise Receives: Device: BFR Exercise (50% of the LOP) while Leg Press Exercise (4 Sets, All out) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain threshold
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.
Measured: Pre- (Baseline, before Exercise) to immediately Post-Intervention (after the exercise training intervention) and 24 hours after intervention
Quality of Life Score
Hemophilia Joint Health Score
Measured: Pre- (Baseline, before Exercise) to immediately Post-Intervention (after the exercise training intervention) and 24 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Aug 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Franz, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259356
- Sponsor's protocol ID
- 2024_H
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Blood Flow Restriction Training on the Subjective Perception of Pain in Hemophilic Arthropathy of the Knee Joint
- ClinicalTrials.gov ID
- NCT07259356
- Acronym / sponsor ID
- 2024_H
- Conditions
- Hemophilia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Condition | Active comparator | Device: ControlSham-BFR Leg Press Exercise |
| Intervention Condition | Experimental | Device: BFR Exercise (50% of the LOP) while Leg Press Exercise (4 Sets, All out)BFR Leg Press Exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with haemophilia
- Ability for an exercise intervention
Key exclusion criteria (3 listed)
- Sickle Cell Anemia
- Intravascular stents/bypasses
- Open Wounds/Infections of the lower extremity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlSham-BFR Exercise (20mmHg) while Leg Press Exercise (4 Sets, All out) | Device | Control Condition |
| BFR Exercise (50% of the LOP) while Leg Press Exercise (4 Sets, All out)BFR Exercise (50% of the LOP) while Leg Press Exercise (4 Sets, All out) | Device | Intervention Condition |
Primary outcome
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BFR Exercise (50% of the LOP) while Leg Press Exercise (4 Sets, All out) in people with Hemophilia, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain threshold (time frame: Pre- (Baseline, before Exercise) to immediately Post-Intervention (after the exercise training intervention) and 24 hours after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.