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Completed

NCT Number: NCT02851082

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

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.

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Toulouse

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endurance training program

Other

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.

Primary outcomes

  1. Determine the acceptability of a 6-weeks endurance training program in patients with haemophilia A as assessed by specific clinical follow-up

    Time frame: During 6 weeks

Secondary outcomes

  1. Variation of Factor VIII in response to acute exercise before and after the endurance training program as assessed by specific bioassay

    Time frame: Day 1 and after 6 weeks of training program

  2. Variation of von Willebrand Factor in response to acute exercise before and after the endurance training program as assessed by specific bioassay

    Time frame: Day 1 and after 6 weeks of training program

  3. Variation of von Willebrand propeptide in response to acute exercise before and after the endurance training program as assessed by specific bioassay

    Time frame: Day 1 and after 6 weeks of training program

  4. Variation of maximal oxygen uptake in response to acute exercise before and after the endurance training program as assessed by specific endurance testing

    Time frame: Day 1 and after 6 weeks of training program

  5. Variation of VO2max in response to acute exercise before and after the endurance training program as assessed by specific endurance testing

    Time frame: Day 1 and after 6 weeks of training program

  6. 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

    Time frame: Day 1 and after 6 weeks of training program

    The Haem-A-QoL questionnaire was specifically designed for adults with haemophilia

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: END-HEMO

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 1, 2016
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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