Study protocol

The effect of an exercise intervention on aerobic fitness, strength and quality of life in children with haemophilia (ACTRN012605000224628)

Carolyn R Broderick^1,2 , Robert D Herbert³ , Jane Latimer³ , Julie A Curtin⁴ and Hiran C Selvadurai⁵

¹School of Medical Sciences, Faculty of Medicine, University of New South Wales, Sydney 2052, Australia

²Children's Hospital Institute of Sports Medicine, The Children's Hospital at Westmead, Westmead, NSW 2145, Australia

³School of Physiotherapy, University of Sydney, Lidcombe NSW 1825, Australia

⁴Department of Haematology, The Children's Hospital at Westmead, Westmead, NSW 2145, Australia

⁵Department of Respiratory Medicine, The Children's Hospital at Westmead, Westmead, NSW 2145, Australia

author email corresponding author email

BMC Blood Disorders 2006, 6:2doi:10.1186/1471-2326-6-2

Published:	29 May 2006

Abstract

Background

Children with haemophilia have lower levels of fitness and strength than their healthy peers. We present the protocol of a study designed to determine whether an exercise intervention improves quality of life, aerobic fitness and strength in children with haemophilia.

Methods/Design

The study will be a randomised, assessor-blinded, controlled trial of exercise treatment. Seventy children aged between 6 and 18 years with haemophilia or von Willebrand disease will be recruited from two paediatric haemophilia clinics in NSW. Each participant will be allocated to an exercise group or a control group using a concealed allocation procedure. The control group will receive usual medical care while the intervention group will receive usual medical care plus an exercise program for 12 weeks. Outcomes (VO_2peak, knee extensor strength and quality of life) will be measured at baseline and on completion of the exercise program by a blinded assessor. The primary analysis will be conducted on an intention to treat basis. The effects of the exercise intervention on each of the three primary outcomes will be estimated from between-group differences in the mean outcome adjusted for baseline scores.

Discussion

This study will be the first randomised controlled trial to examine the effects of a structured exercise program on fitness and quality of life in children with haemophilia.