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

Not Applicable

Completed

• Conditions: Hemophilia A
• Interventions: Other: Endurance training program

• Registration Number: NCT02851082
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-07-27
• Study First Submitted QC: 2016-07-27
• Study First Posted: 2016-08-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Haemophilia A patients	Endurance training program	Patients will perform endurance training program on 6 consecutive weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	Day 1 and after 6 weeks of training program	The Haem-A-QoL questionnaire was specifically designed for adults with haemophilia

Trial Locations

Locations (1)

University Hospital of Toulouse; 🇫🇷 Toulouse, France