Primary objectives:1. To quantify physical activity, sports participation and exposure according to age, haemophilia severity and joint status;2. To assess the incidence of sports-related injuries in those who participate in sports at least once…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Sports participation Including type, duration, frequency and level.
- Sports is defined as "all forms of physical activity which, through casual
or organised participation, aim at expressing or improving physical
fitness and mental well-being, forming social relationships or obtaining
results in competition at all levels."
- Type of sports will be collected using the Modified Activity Questionnaire
(MAQ) for children and adults.
- Duration and frequency will be collected using the accelerometers and
activity diary that we will ask our participants to complete.
- Level is described as the number of training and game sessions per week:
1. untrained (*1x/week),
2. recreationally trained (1-2x/week)
3. trained (3x/week)
4. well-trained (>4-5x/week)
5. professional (>5x/week).
For those performing sports at least once per week and participating in injury
registration, duration and frequency per week will be recorded for every season
(spring, summer, fall, winter), as sports participation varies throughout the
year.
2. Sports Injuries: including nature, location, severity, mechanism, date.
Sports injuries will be collected using a standardized form. Participants will
be contacted by the researcher every two weeks via their preferred method.
In case of a reported injury, a standardized form will be completed by the
researcher to collect detailed, specific injury data. Participants will be
actively followed by to researcher to document any injuries.
Nature: Bone, joint, ligament, muscle, etc.
Location: Anatomical
Severity: Total time loss from work/school and sports
participation
Mechanism: Description of the originating trauma/overload; predefined
mechanisms
Risk categories: Sports will be classified according to the risk
classifications used by the National Hemophilia Foundation (NHF). This
classification consists of 5 categories in which sports are classified
reflecting the risk of acute injury or collision that can be expected while
participating in a specific activity:
1. Safe
1.5 Safe to moderate risk
2 Moderate risk
2.5 Moderate risk to dangerous
3 Dangerous
Secondary outcome
Bleeding data:
- Bleeding
- Joint bleed
- Soft-tissue bleed
- Re-bleed (after an initial moderate to excellent response to treatment, a new
bleed (both joint and soft-tissue) is defined as a bleed occurring >72 h after
stopping treatment for the original bleed for which treatment was initiated.
All other bleeds will be considered new bleeds).
Background summary
Physical activity is part of a healthy lifestyle and promotes general
well-being. In addition, regular physical exercise is especially recommended
for patients with haemophilia 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 usually 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 have
gradually become more active in many different sports, including those
considered to increase bleeding risk, such as soccer. This had lead to concerns
about an increased bleeding risk on one hand, on the other hand it has lead to
criticism from society and some haemophilia consultants.
Data on associated bleeding risk or sport related injuries and the role of
consumption and timing of FVIII/FIX administration in injuries is currently
lacking. It is important to increase our knowledge in this area to be able to
improve our advises regarding sports, exercise and injury prevention for
patients with haemophilia.
Study objective
Primary objectives:
1. To quantify physical activity, sports participation and exposure according
to age, haemophilia severity and joint status;
2. To assess the incidence of sports-related injuries in those who participate
in sports at least once every week;
3. To compare the incidence of sports-related injuries to the general male
population;
4. To assess the association of sports-related injuries with physical fitness
and motor proficiency.
Secondary objectives:
1. To assess/model the association between FVIII/IX activity at the time of
bleeding due to sports injuries and the time of administering of clotting
factor, independent of age, presence of arthropathy, motor proficiency and
physical fitness.
Study design
For assessment of sports participation: cross-sectional observational
single-centre study.
For assessment of the association of sports participation and FVIII/IX levels
with sports-related injuries and bleeding: observational single-centre cohort
study with one year follow-up.
Study burden and risks
Patient risks are considered minimal as this will be an observational study
without any invasive measurements. Patient burden will consist of completing
two questionnaires (±20 minutes), a single test session of physical fitness and
motor proficiency (±1.5 hour), wearing an accelerometer (1 week, 8-12 hours per
day), completing sports diaries during this same period (5 minutes per day) and
reporting sports injuries (5 minutes per week).
Questionnaires will be completed during regular clinic visits, or will be sent
home to the participants. If possible, assessments of physical fitness and
motor proficiency will be performed on days that patients visit the clinic for
their regular visits. Only if this is not possible, participants will be asked
to visit the clinic once for the physical fitness and motor proficiency
assessments. To limit travel time and demands on the participants,
participating patients that do not have an appointment at the clinic within a
reasonable period will be given the opportunity to be tested in their region of
habitat.
The procedures for testing patients externally will be identical to those when
tested at the UMC Utrecht: based on the results of the MAQ, patients are deemed
eligible for participation or not. In case of an eligible patient, their
physician or physiotherapist at the van Creveldkliniek will ask whether the
patient is interested in participating in this study. When a patient is
interested, the investigator will send a patient information form with informed
consent form for more information (see section 9.6: 'recruitment and consent*).
The investigator will contact the patient after 2 weeks to answer any questions
and to ask whether the patient is willing to participate in the study. In case
of an external test site, this is explicitly communicated with the patient.
The testing procedure on location is identical to the procedure described in
section 7.3 of the protocol (*study procedures*). Quality of the testing is
warranted because the same protocol, same equipment (which is transported from
the UMC Utrecht) and same researcher will be used during the external
measurements. The protocol is unaltered and will be identical to the one used
in the UMC Utrecht. The only thing that changes is the location. These
locations will be private physiotherapy clinics, thereby assuring safety to the
participants due to the demands placed on these practices. It needs to be
stressed that the clinics that will be used will not be part of the study, we
will only use their location and facilities
Participants will be asked to wear accelerometers on a daily basis for a period
of maximal 1 week. During this period, it's important to wear these devices for
at least seven consecutive days. An accelerometer is a small (approximately
3x3x1 cm) and light (approximately 20 grams) device that is worn at the hip.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
For cross-sectional assessment of sports participation (questionnaires): all
haemophilia A and B patients with factor VIII/IX levels of 0-30% aged 6 to 65
years (N<= ±450), For the longitudinal follow-up (sports participation and
FVIII/IX levels with sports-related injuries and bleeding): all patients with
severe, moderate or mild haemophilia A or B (factor VIII/IX levels of 0-30%),
aged 6 to 47 years (born between 1-1-1970 and 31-12-2011), who are engaged in
(organised) sports at least once per week (N<= ±200).
Exclusion criteria
Refusal to participate or provide informed consent;
Presence of inhibitory antibodies against FVIII or FIX;
Arthroplasty or arthrodesis within the last 12 months.
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 | NL62291.041.17 |