A new clinical trial that aims to assess the effects of exercise on patients with hemophilia is in the recruitment phase.
The study aims to enroll 132 male children with hemophilia. Boys aged 6 to 12 years with severe or moderate hemophilia A or B will be considered eligible for the study.
Those with von Willebrand disease, past history of fracture or trauma to the lower limb, orthopedic surgery, acquired brain injury or any other disturbance of the central nervous system, joint or muscle bleed in the lower limb in the past 6 weeks, and presence of lower limb pain will be excluded from the study.
Participants will be randomly allocated to 2 groups. One group will receive a 12-week exercise intervention, while the other will continue to receive their usual care as prescribed by the hematologist, physiotherapist, and other members of their healthcare team.
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According to the study protocol, the primary outcome measure will be the muscle strength of the dominant knee extensors at 24 weeks. The researchers will also analyze the muscle strength of the ankle plantar flexors and nondominant knee extensors, bleeding episodes and coagulation factor usage, 6-minute timed walk, timed up and down stairs, participation in physical activity, and Child Health Utility 9D after 24 weeks as secondary outcome measures.
“Being able to participate in games and activities with their friends is one of the things that matter most to boys with hemophilia. At present, there is a lack of robust evidence to determine whether muscle strengthening exercise can improve or negatively affect outcomes for young children with hemophilia,” the researchers wrote.
The estimated primary completion and actual study completion date are set as July 30, 2025. The study is sponsored by East Kent Hospitals University NHS Foundation Trust.
Trial of an exercise intervention for children with haemophilia (DOLPHIN-II). ClinicalTrials.gov. Last updated June 8, 2023. Accessed June 18, 2023.