The aim of this study is to investigate whether exercise changes FVIII levels in patients with moderate and mild haemophilia.
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is the change in FVIII levels because of
exercise in moderate and mild haemophilia A patients.
Secondary outcome
The secundary endpoints of this study are von Willebrand factor, von
Willebrand propeptide and t-PA before and 10 minutes after exercise in moderate
and mild haemophilia A patients.
Background summary
Besides the fact that exercise is part of a healthy lifestyle, it is shown that
exercise increases levels of factor VIII (FVIII) in healthy subjects. It has
been suggested that moderate and mild haemophilia A patients are also able to
increase their endogenous FVIII levels during exercise. If FVIII increases in
moderate and mild haemophilia A patients during exercise, patients might reduce
the risk of bleeding episodes. This might have positive implications towards
docters'recomendations concerning sports and subsequently increase quality of
life.
Study objective
The aim of this study is to investigate whether exercise changes FVIII levels
in patients with moderate and mild haemophilia.
Study design
In this trial, coagulation components of 20 patients with FVIII levels from
1-20% will be measured before and 10 minutes after a standardised incremental
exercise test, till volitional exhaustion, on an electronically braked cycle
ergometer. Blood samples will be drawn according to the Van Creveldkliniek,
haemophilia treatment centre protocol. FVIII levels, von Willebrand factor
(vWf), propeptide, bloodtype and t-PA will be tested in one batch, via standard
laboratory protocol.
Study burden and risks
Participants will be subjected to 1 extra venapuncture and an incremental
exercise test. Their routine visit will be extended by approximately 30
minutes. the risk is considered to be minimal. A certified and experienced
nurse will draw bloodsamples following haemophilia treatment center protocol.
Postbus 85500
3508 ab Utrecht
Nederland
Postbus 85500
3508 ab Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
• Haemophilia A
• FVIII activity 1-20%.
• 18-40 years of age
• Male
• Normally active
• Able to complete the exercise test without great difficulty
Exclusion criteria
• History of inhibitors
• No access to standard haemophilia care since birth (e.g. immigration from other country)
• Joint damage which complicates riding a bicycle
• A known medical condition that may deteriorate during strenuous physical activities
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26839.041.09 |