Health TrialsbyHealthPanel

Trial of an Exercise Intervention for Children With Haemophilia

ConditionsHemophiliaChild, OnlyMusculoskeletal Diseases or Conditions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age6-12
SponsorEast Kent Hospitals University NHS Foundation Trust

About this trial

"Being able to participate in games and activities with their friends" is one of the things that matters most to boys with haemophilia. 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 haemophilia. With the help of boys with haemophilia, their parents and physiotherapists the investigators have developed an exercise programme designed to increase muscle strength. Using this intervention the investigators will undertake a single-blinded, two-arm pragmatic randomised controlled trial (RCT) of a 12-week intervention verses usual care of boys with haemophilia aged 6-12 years of age.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

von Willebrand disease

past history of fracture or trauma to the lower limb

orthopaedic 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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise

    Other intervention

    12-week exercise intervention

  • Usual Care

    Other intervention

    usual care

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: ExerciseExperimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Muscle strength of the dominant knee extensors at 24 weeks

Maximum isometric torque (Newton.metres/kilogram of body weight)

Time frame
24-weeks

Secondary outcomes

1

Muscle strength of the ankle plantarflexors and non-dominant knee extensors at 24 weeks

maximum isometric torque (Newton.metres/kilogram of body weight)

Time frame
24 weeks
2

Bleeding episodes and coagulation factor usage

Number of bleeding episodes (number) and amount of coagulation factor used for treatment (number)

Time frame
24 weeks
3

Six-minute timed walk (6MTW)

Distance walked in 6 minutes (metres)

Time frame
24 weeks
4

Timed up and down stairs (TUDS)

Time taken to ascend and descend a flight of 12 steps (seconds)

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

East Kent Hospitals University NHS Foundation Trust

Lead sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Collaborator

University of Kent

Collaborator

Source ClinicalTrials.gov
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