|- candidate number||28077|
|- NTR Number||NTR6769|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-okt-2017|
|- Secondary IDs||NL69221.041.17 toetsingonline.nl - CCMO/METC|
|- Public Title||Do patients with haemophilia differ from the general population regarding sports activity and injuries? |
|- Scientific Title||Sports Participation and Injuries in Patients with Haemophilia|
|- hypothesis||In Haemophilia patients:|
1. Sports participation is dependent on age, joint status, perceived limitations and severity of haemophilia;
2. Sports participation is lower than sports participation in the general population/age matched, healthy peers;
3. Sports (related) injuries are different from those in the general population/age matched healthy peers;
4. The dose of FVIII/IX prophylaxis and timing of administration in relation to sporting events are associated with sports injury risk;
5. Joint health status, physical fitness and motor proficiency are associated with the occurrence sports injuries.
|- Healt Condition(s) or Problem(s) studied||Haemophilia, Physical activity, Sports injury|
|- Inclusion criteria||All patients with haemophilia A or B (FVIII/IX levels 0-30%), aged 6-65 years, treated at the Van Creveldkliniek. |
|- Exclusion criteria||- Refusal to participate or provide informed consent;|
- Presence of inhibitory antibodies against FVIII or FIX;
- Recent surgery: arthroplasty or arthrodesis within the last 12 months.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-nov-2017|
|- planned closingdate||31-jan-2020|
|- Target number of participants||600|
|- Interventions||This study consists of a cross-sectional baseline study in which sports participation and perceived limitations are studied.|
Based on the outcomes of these questionnaires, participants will be selected (moderate of severe haemophilia A or B, aged 6-47, actively engaged in sports at least once per week) for a prospective follow-up study.
In this follow-up, there will be a cross-sectional test for aerobic endurance and motor proficiency, followed by a one year follow-up in which sports activity will be assessed objectively (accelerometers) and subjectively (training diaries), while sports injuries will be recorded by the researcher.
|- Primary outcome||- To quantify physical activity (PA), sports participation and exposure according to age, haemophilia severity and joint status;|
- To assess the incidence of sports-related injuries in those who participate in sports at least once every week;
- To compare the incidence of sports-related injuries to the general male population.
- To assess the association of sports-related injuries with physical fitness and motor proficiency.
|- Secondary outcome||To assess/model the effect of FVIII/IX activity at the time of bleeding due to sports injuries, independent of age, presence of arthropathy, motor proficiency and physical fitness. |
|- Timepoints||Data collection (cross-sectional and follow-up): 24 months |
Data analysis: 6 months
Reporting: 6 months
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Olav Versloot|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. Kathelijn Fischer|
|- Sponsor/Initiator ||Van Creveldkliniek - UMC Utrecht|
(Source(s) of Monetary or Material Support)
|- Brief summary||Regular physical exercise is recommended for patients with haemophilia (PWH) to increase muscle strength and bone density and maintain muscle mass. As overexertion and high impact sports are considered to increase the risk of (joint) bleeding, patients with haemophilia were traditionally advised to limit themselves in engaging in low-impact sports like swimming and cycling. |
In the setting of intensive treatment, most patients with severe haemophilia are now engaging in many different sports, including those considered to increase bleeding risk, such as soccer. Although data on participation in sports are increasing, data on associated bleeding risk or sport related injuries is currently lacking.
Primary objective for this study is to assess sports participation as well as bleeding and/or injuries associated with sports participation, including a comparison to the general population and association with clotting factor levels. Secondary objectives is to assess/model the effect of FVIII/IX activity at the time of bleeding due to sports injuries, independent of age, presence of arthropathy, motor proficiency and physical fitness.
|- Main changes (audit trail)|
|- RECORD||24-okt-2017 - 5-nov-2017|