Feasibility and Safety of Blood-Flow-Restriction Training in Patients With Hemophilia

NCT07259356 | Enrolling By Invitation

• 1 other identifier: 2024_H
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemophilia

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Pre- (Baseline, before Exercise) to immediately Post-Intervention (after the exercise training intervention) and 24 hours after intervention

Study Arms (2)

Control Condition

ACTIVE COMPARATOR

Sham-BFR Leg Press Exercise

Device: Control

Intervention Condition

EXPERIMENTAL

BFR Leg Press Exercise

Device: BFR Exercise (50% of the LOP) while Leg Press Exercise (4 Sets, All out)

Interventions

Control DEVICE

Sham-BFR Exercise (20mmHg) while Leg Press Exercise (4 Sets, All out)

Control Condition

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)

Intervention Condition

Eligibility Criteria

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

You may qualify if:

• patients with haemophilia
• Ability for an exercise intervention

You may not qualify if:

• Sickle Cell Anemia
• Intravascular stents/bypasses
• Open Wounds/Infections of the lower extremity

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: December 2, 2025
• Study Start: August 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)