VECTOR
Research type
Research Study
Full title
Vibrational exercise for Crohn's Disease to observe response - VECTOR
IRAS ID
339311
Contact name
L Bottoms
Contact email
Sponsor organisation
University of Hertfordshire
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Crohn's disease (CD) is a long‐term inflammatory condition of the digestive system. People with CD often have unpredictable and debilitating symptoms, including abdominal pain, diarrhoea, and fatigue. They also require long-term treatment with frequent negative effects and often need surgery and hospitalisations. Therefore, people with CD report a low health-related quality of life.
Exercise might be a simple, safe, low-cost intervention for improving HRQOL in people with CD. This is because it can potentially simultaneously improve several aspects of physical, mental and social well-being. Adults with CD have been shown to be less active than the general population. One barrier to exercise is lack of time, however whole-body vibration exercise (where you stand and squat on a vibrating plate) can be done over a much shorter duration and at a lower intensity to gain potentially similar or at times greater benefits.
This study begins to understand whether undertaking a supervised 6-week vibration exercise programme for adults with mild to moderately active Crohn’s disease improves HRQoL and other symptoms such as fatigue.
The study will recruit 168 adults with mild to moderately active CD. After initial assessments, participants will be randomised to a 6-week supervised whole body vibration exercise programme alongside a lifestyle education programme or lifestyle education programme only. Both groups will receive the same contact time with the research team and their usual care for their CD. Participants will complete assessments of their HRQOL, disease activity, inflammation, physical fitness, subjective fatigue, muscle fatigue and mental health. We will also conduct a phone interview at the end of the trial to understand the participants' experience of receiving the vibration exercise.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
24/EM/0106
Date of REC Opinion
7 Aug 2024
REC opinion
Further Information Favourable Opinion