Clinical trial NCT02851082: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia A
Keywords: Training Program
Endurance
Von Willebrand factor
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Determine the acceptability of a 6-weeks endurance training program in patients with haemophilia A as assessed by specific clinical follow-up
timeFrame: During 6 weeks
Secondary outcomes:
measure: Variation of Factor VIII in response to acute exercise before and after the endurance training program as assessed by specific bioassay
timeFrame: Day 1 and after 6 weeks of training program
measure: Variation of von Willebrand Factor in response to acute exercise before and after the endurance training program as assessed by specific bioassay
timeFrame: Day 1 and after 6 weeks of training program
measure: Variation of von Willebrand propeptide in response to acute exercise before and after the endurance training program as assessed by specific bioassay
timeFrame: Day 1 and after 6 weeks of training program
measure: Variation of maximal oxygen uptake in response to acute exercise before and after the endurance training program as assessed by specific endurance testing
timeFrame: Day 1 and after 6 weeks of training program
measure: Variation of VO2max in response to acute exercise before and after the endurance training program as assessed by specific endurance testing
timeFrame: Day 1 and after 6 weeks of training program
measure: Variation of quality of life of patients in response to acute exercise before and after the endurance training program as assessed by Haem-A-QoL questionnaire
timeFrame: Day 1 and after 6 weeks of training program
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital of Toulouse
name: Fabien PILLARD, MD
role: PRINCIPAL_INVESTIGATOR
References: