EXACT - Exercise for Adults with Crohn's disease Trial

Crohn’s disease (CD) is a relapsing inflammatory disease, mainly affecting the gastrointestinal tract, and frequently presents with abdominal pain, fever, and clinical signs of bowel obstruction or diarrhoea with passage of blood or mucus, or both. Physical exercise, whilst not currently part of the recommended treatment pathway, has been proposed as a potentially useful adjunctive therapy for CD because it may counteract some disease-specific complications by improving immunological response and psychological health, reducing fatigue, and promoting gains in muscle and bone strength. The effects of exercise training depend largely on the type, intensity and volume of the exercise stimulus. The most commonly-used model of exercise prescription in other chronic diseases has been moderate-intensity continuous training (MICT) - e.g. 30 minute of moderate-intensity continuous cycling thrice weekly - because it is well-tolerated and has beneficial effects on many different aspects of physical and mental health. However, a growing body of evidence indicates that shorter bouts of intense intermittent exercise – so-called ‘high intensity interval training’ (HIIT), e.g., 1 minute hard cycling followed by 1 minute easy cycling repeated 10 times – can elicit similar physiological adaptations compared to more-lengthy continuous exercise.

This three-arm, parallel-group, randomised controlled feasibility trial in adults with inactive or mildly active CD aims to: (i) inform the design of, and assess the feasibility of conducting, a large-scale randomised trial, and; (ii) explore the acceptability, safety and potential benefits of HIIT and MICT in this clinical population, relative to usual care. We aim to recruit 45 participants from three NHS Hospital Trusts.

The main focus of this study is feasibility and acceptability of procedures for recruitment, allocation, measurement, retention and for the intervention procedures. Secondary clinical measures will include cardiorespiratory fitness, disease status and relapse, and patient reported outcome measures including the Inflammatory Bowel Disease Quality of Life Questionnaire (IBDQ), EuroQol EQ-5D-5L, IBD Fatigue Scale, Hospital and Anxiety Depression Scale (HADS), and International Physical Activity Questionnaire (IPAQ) – Short Form.

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Funding

Funder:   Crohn's and Colitis UK 
Start date:  1 January 2016
Expiry date: 31 December 2017

Members

Internal Staff

External Collaborators

Trials and Statistics Research in the Department of Health Sciences