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Protocol for a feasibility randomised controlled trial of a musculoskeletal exercise intervention versus usual care for children with haemophilia

Hashem, Ferhana, Bladen, Melanie, Carroll, Liz, Dodd, Charlene, Drechsler, Wendy, Lowery, David, Patel, Vishal, Pellatt-Higgins, Tracy, Saloniki, Eirini-Christina, Stephensen, David and others. (2019) Protocol for a feasibility randomised controlled trial of a musculoskeletal exercise intervention versus usual care for children with haemophilia. BMJ Open, 9 (8). Article Number 29474. E-ISSN 2044-6055. (doi:10.1136/bmjopen-2019-029474) (KAR id:74480)

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Abstract

Introduction: Haemophilia is a rare, inherited disorder in which blood does not clot normally, resulting in bleeding into joints and muscles. Long-term consequence is disabling joint pain, stiffness, muscle weakness, atrophy and reduced mobility. The purpose of this proposed feasibility of a randomised controlled trial (RCT) is to test the feasibility of an age-appropriate physiotherapy intervention designed to improve muscle strength, posture and the way boys use their joints during walking and everyday activities. Methods and analysis: A small-scale two-centre RCT of a 12-week muscle strengthening exercise intervention versus usual care for young children with haemophilia will be conducted. Primary outcomes will be safety and adherence to the exercise intervention. Secondary outcomes will include: recruitment, retention and adverse event rates, clinical data, muscle strength, joint biomechanics and foot loading patterns during walking, six-minute timed walk, timed-up-and-down-stairs, EQ-5D-Y, participants’ perceptions of the study, training requirements and relevant costs. Recruitment, follow-up, safety and adherence rates will be described as percentages. Participant diary and interview data will be analysed using a framework analysis. Demographic and disease variable distributions will be analysed for descriptive purposes and co-variant analysis. Estimates of differences between treatment arms (adjusted for baseline), and 75% and 95% confidence intervals will be calculated.

Ethics and Dissemination: The study has ethical approval from the London - Fulham Research Ethics Committee (17/LO/2043) as well as Health Research Authority approval. As well as informing the design of the definitive trial, results of this study will be presented at local, national and international physiotherapy and haemophilia meetings as well as manuscripts submitted to peer-reviewed journals. We will also share the main findings of the study to all participants and the Haemophilia Society.

Item Type: Article
DOI/Identification number: 10.1136/bmjopen-2019-029474
Uncontrolled keywords: haemophilia, physiotherapy, exercise, muscle strength, physical function
Subjects: H Social Sciences
Divisions: Faculties > Social Sciences > School of Social Policy Sociology and Social Research > Centre for Health Services Studies
Depositing User: Meg Dampier
Date Deposited: 20 Jun 2019 16:10 UTC
Last Modified: 17 Sep 2020 15:58 UTC
Resource URI: https://kar.kent.ac.uk/id/eprint/74480 (The current URI for this page, for reference purposes)
Hashem, Ferhana: https://orcid.org/0000-0002-2544-1350
Pellatt-Higgins, Tracy: https://orcid.org/0000-0002-2543-461X
Saloniki, Eirini-Christina: https://orcid.org/0000-0002-5867-2702
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