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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02253693
Study type Observational [Patient Registry]
Source University of Valencia
Contact
Status Completed
Phase N/A
Start date January 2015
Completion date January 2017

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