Could Physical Activity Help to Counteract the Blood Haemophilia Disturbance? A Pilot Study. (END-HEMO)

Protected by Nature: 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.

Study Overview

• Status: Completed
• Conditions: Hemophilia A
• Intervention / Treatment: Other: Endurance training program

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • University Hospital of Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Haemophilia A patients; Patients will perform endurance training program on 6 consecutive weeks

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Fabien PILLARD, MD, University Hospital of Toulouse

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: July 27, 2016
• First Submitted That Met QC Criteria: July 27, 2016
• First Posted (Estimate): August 1, 2016

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 21, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Endurance; Training Program; Von Willebrand factor
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Hemophilia A
• Other Study ID Numbers: 15 7674 03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided