Trial of an Exercise Intervention for Children With Haemophilia

NCT05895032 | Recruiting DMC

• 1 other identifier: 2020/HAEMO/01
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

"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.

Conditions

Hemophilia; Child, Only; Musculoskeletal Diseases or Conditions

Keywords

Physical Therapy; Exercise; Muscle strength

Outcome Measures

Primary Outcomes (1)

• Muscle strength of the dominant knee extensors at 24 weeks

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

  24-weeks

Secondary Outcomes (6)

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

  24 weeks

• Bleeding episodes and coagulation factor usage

  24 weeks

• Six-minute timed walk (6MTW)

  24 weeks

• Timed up and down stairs (TUDS)

  24 weeks

• Participation in physical activity

  24 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

12-week exercise intervention

Other: Exercise

Usual care

ACTIVE COMPARATOR

Participants will continue to receive their usual care as prescribed by the haematologist, physiotherapist and other members of the healthcare team.

Other: Usual Care

Interventions

Exercise OTHER

12-week exercise intervention

Exercise

Usual Care OTHER

usual care

Usual care

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6-12 years, with severe or moderate haemophilia A or B

You may not qualify if:

• 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
• presence of lower limb pain or unable to fully comply with verbal instructions.

Sponsors & Collaborators

• East Kent Hospitals University NHS Foundation Trust: lead
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator
• University of Kent: collaborator

Study Sites (1)

Haemophilia Centre

Canterbury, Kent, CT1 3NG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hemophilia A; Musculoskeletal Diseases; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• David Stephensen, PhD

  East Kent Hospitals University NHS Foundation Trust

  STUDY CHAIR

Central Study Contacts

David Stephensen, PhD

CONTACT

01227783166; david.stephensen@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: It is impossible to blind those in receipt and those delivering the intervention as to group allocation. However, it will be possible, although perhaps challenging, to blind the assessor to group allocation. Consequently, we will attempt a single blind approach in which the participant and physiotherapists delivering the intervention will be encouraged to withhold their group allocation from the assessors collecting data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A single-blinded, two-arm pragmatic randomised controlled trial

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: June 8, 2023
• Study Start: May 6, 2021
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)