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

NCT02851082 | Completed

• 1 other identifier: 15 7674 03
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophilia A

Keywords

Training Program; Endurance; Von Willebrand factor

Outcome Measures

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

  During 6 weeks

Secondary Outcomes (6)

• 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

Study Arms (1)

Haemophilia A patients

EXPERIMENTAL

Patients will perform endurance training program on 6 consecutive weeks

Other: Endurance training program

Interventions

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.

Haemophilia A patients

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Women
• Absence of signed consent
• Patient protected by Justice

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital of Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

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

Study Officials

• Fabien PILLARD, MD

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: August 1, 2016
• Study Start: April 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

FR (1)