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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02851082
Acronym
END-HEMO
Enrollment
18
Registered
2016-08-01
Start date
2016-04-30
Completion date
2017-01-31
Last updated
2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Keywords

Training Program, Endurance, Von Willebrand factor

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.

Interventions

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.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Determine the acceptability of a 6-weeks endurance training program in patients with haemophilia A as assessed by specific clinical follow-upDuring 6 weeks

Secondary

MeasureTime frameDescription
Variation of von Willebrand Factor in response to acute exercise before and after the endurance training program as assessed by specific bioassayDay 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 bioassayDay 1 and after 6 weeks of training program
Variation of Factor VIII in response to acute exercise before and after the endurance training program as assessed by specific bioassayDay 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 testingDay 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 questionnaireDay 1 and after 6 weeks of training programThe Haem-A-QoL questionnaire was specifically designed for adults with haemophilia
Variation of maximal oxygen uptake in response to acute exercise before and after the endurance training program as assessed by specific endurance testingDay 1 and after 6 weeks of training program

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026