Sports Participation and Injuries in Patients with Haemophilia

Sports Participation and Injuries in Patients with Haemophilia - SPRAIN

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50696

Enrollment

450

Registered

2018-04-04

Start date

2018-10-03

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding disorder sports injury

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
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).	—

Countries

Netherlands

Outcome results