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

Primary Purpose

Hemophilia A

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Endurance training program
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilia A focused on measuring Training Program, Endurance, Von Willebrand factor

Eligibility Criteria

18 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Toulouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Haemophilia A patients

Arm Description

Patients will perform endurance training program on 6 consecutive weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Variation of Factor VIII in response to acute exercise before and after the endurance training program as assessed by specific bioassay
Variation of von Willebrand Factor in response to acute exercise before and after the endurance training program as assessed by specific bioassay
Variation of von Willebrand propeptide in response to acute exercise before and after the endurance training program as assessed by specific bioassay
Variation of maximal oxygen uptake in response to acute exercise before and after the endurance training program as assessed by specific endurance testing
Variation of VO2max in response to acute exercise before and after the endurance training program as assessed by specific endurance testing
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

Full Information

First Posted
July 27, 2016
Last Updated
February 21, 2017
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02851082
Brief Title
Could Physical Activity Help to Counteract the Blood Haemophilia Disturbance? A Pilot Study.
Acronym
END-HEMO
Official Title
Protected by Nature: Could Physical Activity Help to Counteract the Blood Haemophilia Disturbance? A Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia A
Keywords
Training Program, Endurance, Von Willebrand factor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Haemophilia A patients
Arm Type
Experimental
Arm Description
Patients will perform endurance training program on 6 consecutive weeks
Intervention Type
Other
Intervention Name(s)
Endurance training program
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Description
The Haem-A-QoL questionnaire was specifically designed for adults with haemophilia
Time Frame
Day 1 and after 6 weeks of training program

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabien PILLARD, MD
Organizational Affiliation
University Hospital of Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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