Status:
COMPLETED
Exploratory Pilot Study of Physical Activity Monitoring in Adult Patients With Haemophilia A by Means of Accelerometry
Lead Sponsor:
University of Valencia
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Hemophilia A, Congenital
Eligibility:
MALE
18-65 years
Brief Summary
Research Question: Does an specific and pre-defined physical exercise prescribed by a specialist provide any benefit on haemophilic arthropathy, the quality of life or the physical condition of patien...
Detailed Description
Specific details of Treatment/Intervention: Physical exercises that are part of the specific medical program prescribed for each patient. The exercise program for each patient will depend of the haem...
Eligibility Criteria
Inclusion
- Male patients over 18
- Patients diagnosed with haemophilia A and under prophylaxis treatment with the same FVIII for 2 years prior to the inclusion in the study.
- Patients with haemophilic arthropathy in, at least, one of the four load-bearing joints (knees and ankles), according to clinical and/or radiographic criteria (at least 3 in the Gilbert scale and /or at least 3 in the Pettersson scale) and/or Chronic synovitis evidenced by ultrasound.
- Patients with signed informed consent.
Exclusion
- Patients who have developed an inhibitor antibody (≥5 Bethesda units), at the moment of the inclusion in the study.
- Development of inhibitors
- Modification, during follow-up, of FVIII with which the patient started the study.
- The patient decides to withdraw voluntarily from the study.
- Major orthopaedic surgery
Key Trial Info
Start Date :
January 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT02253693
Start Date
January 1 2015
End Date
January 1 2017
Last Update
January 9 2018
Active Locations (2)
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1
University of Valencia
Valencia, Spain, 46010
2
Hospital Universitari i Politècnic La Fe de Valencia
Valencia, Spain, 46026