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

Hemophilia A Clinical Trial

— END-HEMO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02851082
• Other study ID #: 15 7674 03
• Status: Completed
• Phase: N/A
• First received: July 27, 2016
• Last updated: February 21, 2017
• Start date: April 2016
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Other:
• Endurance training program
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.

Locations

Country	Name	City	State
France	University Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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