Exploratory Pilot Study of Physical Activity Monitoring in Adult Patients With Haemophilia A by Means of Accelerometry
Condition: Hemophilia A, Congenital
MeSH terms: Hemophilia A
Study type: Observational [Patient Registry]

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 patients with haemophilia A and haemophilic arthropathy? Does adherence
      to physical exercise improve when monitoring patients with an accelerometer? Do compliant
      patients find higher benefit on haemophilic arthropathy, quality of life or the physical
      condition than non-compliant patients?

      Primary Endpoint: Assess in patients with haemophilia A and haemophilic arthropathy if a
      prescribed and specific physical exercise monitored by an accelerometer is producing any
      change in the following domains: progress of haemophilic arthropathy; health-related quality
      of life; physical condition.

      Secondary Endpoints: Evaluate the adherence to physical exercise in patients with haemophilia
      A and haemophilic arthropathy by means of accelerometry, and asses if compliant patients
      achieve higher improvement in these 3 domains than non-complaint patients.
    

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 haemophilic arthropathy, the level
      of physical condition and the preferences of the patient.

      Monitoring of physical activity will be made by means of accelerometers. Its use does not
      alter the daily activities and does not require any change of the patients' individual
      habits. The assessment of the patients' cardiovascular condition will be made using pulse
      monitors. Normal examinations in clinical practice will be revised as well as those specific
      to each patient reference health centre, muscle strength and joint use testing which will be
      validated with force measurement devices. Assess by means of an ultrasound system the
      baseline situation of the joints used for daily activities for injury control. Determine the
      likelihood of fracture and assess the bone quality by means of densitometry. Thermal cameras
      will allow to analyse the characteristics of Joint inflammation. It may be suitable for
      bleeding evolution control. Measurements given by densitometers will allows to determine the
      state of bones of the participants in the study (osteoporosis measurement). Number of
      bleeding events/hemarthrosis during the period of study. Determine the activity of
      hemarthros/synovitis using thermal images.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with haemophilia A presenting joint disease (haemophilic arthropathy) and
        who are under prophylaxis treatment with FVIII
      
Keywords: Hemophilia A; Hemophilic arthropathy; Accelerometry