Hemophilia AEND-HEMONCT02851082
Could Physical Activity Help to Counteract the Blood Haemophilia Disturbance? A Pilot Study.
A study testing Endurance training program in people with Hemophilia A, run by University Hospital, Toulouse at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Hemophilia A
- What is being tested?
- Endurance training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hemophilia A
- Being tested
- Endurance training program
- Keywords
- Training Program, Endurance, Von Willebrand factor
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance training programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Haemophilia A patients | Experimental | Patients will perform endurance training program on 6 consecutive weeks Receives: Other: Endurance training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the acceptability of a 6-weeks endurance training program in patients with haemophilia A as assessed by specific clinical follow-up
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1 and after 6 weeks of training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabien PILLARD, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851082
- Sponsor's protocol ID
- 15 7674 03
- Acronym
- END-HEMO
- Status last verified
- Feb 2017
- First submitted
- 27 Jul 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protected by Nature: Could Physical Activity Help to Counteract the Blood Haemophilia Disturbance? A Pilot Study.
- ClinicalTrials.gov ID
- NCT02851082
- Acronym / sponsor ID
- END-HEMO / 15 7674 03
- Conditions
- Hemophilia A
- Keywords
- Training Program, Endurance, Von Willebrand factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 1 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Haemophilia A patients | Experimental | Other: Endurance training programPatients will perform endurance training program on 6 consecutive weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endurance training programExercise 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. | Other | Haemophilia A patients |
Primary outcome
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
6 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabien PILLARD, MD principal investigator
University Hospital of Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurance training program in people with Hemophilia A, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.