Could Physical Activity Help to Counteract the Blood Haemophilia Disturbance? A Pilot Study.

Study Overview
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Brief Summary
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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.

Official Title
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Protected by Nature: Could Physical Activity Help to Counteract the Blood Haemophilia Disturbance? A Pilot Study.

Conditions
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Hemophilia A

Intervention / Treatment
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* Other: Endurance training program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Haemophilia A patients<br>Patients will perform endurance training program on 6 consecutive weeks | Other: Endurance training program<br>* Exercise intensity will be fixed to the corresponding powers for ventilatory thresholds, if applicable for pain tolerance. The endurance interval training workout is known to induce metabolic and physiological adaptations. For intermittent workout training protocol, recovery periods at moderate intensity between periods at high intensity help to sustain repeated high intensity periods of exercise. If pain disturbs exercise tolerance, power will be lowered as necessary. A set of 3 training sessions per week of 45 minutes each for 6 consecutive weeks will be proposed (one session every two days). This scheme is usually encouraged for patients suffering from chronic diseases.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the acceptability of a 6-weeks endurance training program in patients with haemophilia A as assessed by specific clinical follow-up |  | During 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of Factor VIII in response to acute exercise before and after the endurance training program as assessed by specific bioassay |  | Day 1 and after 6 weeks of training program | 
| Variation of von Willebrand Factor in response to acute exercise before and after the endurance training program as assessed by specific bioassay |  | Day 1 and after 6 weeks of training program | 
| Variation of von Willebrand propeptide in response to acute exercise before and after the endurance training program as assessed by specific bioassay |  | Day 1 and after 6 weeks of training program | 
| Variation of maximal oxygen uptake in response to acute exercise before and after the endurance training program as assessed by specific endurance testing |  | Day 1 and after 6 weeks of training program | 
| Variation of VO2max in response to acute exercise before and after the endurance training program as assessed by specific endurance testing |  | Day 1 and after 6 weeks of training program | 
| 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 | The Haem-A-QoL questionnaire was specifically designed for adults with haemophilia | Day 1 and after 6 weeks of training program | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Training Program, Endurance, Von Willebrand factor