Actively Recruiting
Development Of a haemophiLia PHysiotherapy INtervention for Optimum Musculoskeletal Health in Children (DOLPHIN-II) - a Randomised Controlled Trial
Led by East Kent Hospitals University NHS Foundation Trust · Updated on 2024-08-30
132
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
E
East Kent Hospitals University NHS Foundation Trust
Lead Sponsor
G
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate whether a specially designed muscle strengthening exercise program can improve outcomes for boys aged 6 to 12 years with haemophilia. Haemophilia is a condition where the blood does not clot normally, causing bleeding into muscles and joints, leading to weakness and pain. The study addresses a key question about the role of exercise in preventing and treating joint damage in young children with haemophilia, as current evidence is lacking. Participants will be randomly assigned to one of two groups: one group will complete a 12-week exercise program aimed at strengthening leg muscles, while the other group will continue with their usual medical care. The exercise program was developed with input from boys with haemophilia, their parents, and physiotherapists to ensure it is suitable and acceptable. Both groups will be monitored over the course of the study. During the study, researchers will assess muscle strength, walking ability through a six-minute walk test, and the time taken to ascend and descend 12 steps. Physical activity will be tracked using a wrist-worn device, and participants' satisfaction with their health will be recorded. The main outcome measured will be muscle strength of the dominant knee extensors at 24 weeks. The study team includes healthcare professionals and parents to ensure meaningful outcomes and effective communication of results to families and the wider community.
CONDITIONS
Brief Title
Trial of an Exercise Intervention for Children With Haemophilia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6-12 years
- Diagnosed with severe or moderate haemophilia A or B
You will not qualify if you...
- Diagnosis of von Willebrand disease
- Past fracture or trauma to the lower limb
- History of orthopaedic surgery
- Acquired brain injury or other central nervous system disturbance
- Joint or muscle bleed in the lower limb within the past 6 weeks
- Presence of lower limb pain or inability to fully comply with verbal instructions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants in the exercise group complete a 12-week exercise routine designed to strengthen their leg muscles. Participants in the usual care group continue their regular care as prescribed by their healthcare team.
Weekly visits for up to 12 weeks
Duration - 12 weeks
Participants are monitored after the exercise intervention to assess muscle strength, walking ability, stair climbing, physical activity, bleeding episodes, and health satisfaction.
1 visit at 24 weeks
Trial Site Locations
Total: 1 location
1
Haemophilia Centre
Canterbury, Kent, United Kingdom, CT1 3NG
Actively Recruiting
Research Team
D
David Stephensen, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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