Brief Title
Could Physical Activity Help to Counteract the Blood Haemophilia Disturbance? A Pilot Study.
Official Title
Protected by Nature: Could Physical Activity Help to Counteract the Blood Haemophilia Disturbance? A Pilot Study.
Brief Summary
Physical activity is lower in patients with haemophilia than in their healthy peers.
Nevertheless, exercize is recommended for those patients and supported by evidence. Until
2013, scientific and medical evidence to encourage physical activity for patients with
haemophilia were listed to increase their locomotor function, their metabolic status, their
fitness level and their well-being. In 2013, an original publication by Groen et al.
suggested that physical activity could also interact with the specific and biological
disturbance of the disease.
We propose to consider that regular endurance exercize prescription should be encouraged in
patients with haemophilia not only for a healthier lifestyle but also because it could
positively alter the specific biological blood disturbance seen in haemophilia. Nevertheless,
before planning a well powered intervention trial we need to determine the acceptability of
regular exercize and the expected value of factor Factor VIII, von Willebrand factor and von
Willebrand propeptide after an endurance training program.
Study Type
Interventional
Primary Outcome
Determine the acceptability of a 6-weeks endurance training program in patients with haemophilia A as assessed by specific clinical follow-up
Secondary Outcome
Variation of Factor VIII in response to acute exercise before and after the endurance training program as assessed by specific bioassay
Condition
Hemophilia A
Intervention
Endurance training program
Study Arms / Comparison Groups
Haemophilia A patients
Description: Patients will perform endurance training program on 6 consecutive weeks
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
18
Start Date
April 2016
Completion Date
January 2017
Primary Completion Date
January 2017
Eligibility Criteria
Inclusion Criteria:
- Mild (FVIII:1-5%) and moderate (FVIII:6-40%) haemophilia A patients,
- Living in the Midi-Pyrenees region,
- Between 18 and 45 years old,
- Exempt from any significant medical condition that could prevent them from being
subjected to an endurance training program,
- Affiliated to a social security cover
Exclusion Criteria:
- Women
- Subjects declaring 2 or more spontaneous bleeding events and/or 4 or more induced
bleeding events out of a traumatic circumstance 6 months prior to inclusion
- Absence of signed consent
- Patient protected by Justice
Gender
Male
Ages
18 Years - 45 Years
Accepts Healthy Volunteers
No
Contacts
Fabien PILLARD, MD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT02851082
Organization ID
15 7674 03
Responsible Party
Sponsor
Study Sponsor
University Hospital, Toulouse
Study Sponsor
Fabien PILLARD, MD, Principal Investigator, University Hospital of Toulouse
Verification Date
February 2017