Gastro-oesophageal Reflux Disease Clinical Trial
Official title:
An Observational Study to Compare the Outcomes of Ambulatory Gastrointestinal Investigations With Physical Activity Using Accelerometry.
This is an observational study, which aims to compare the outcomes of ambulatory
gastrointestinal investigations with physical activity using accelerometry. An ambulatory
study refers to one in which the patient is monitored freely, often outside of the hospital
environment. For this the investigators will use a lightweight (7.4g) tri-axial accelerometer
worn behind the ear.
Hypothesis 1 There is no change in the amount or nature of physical activity taken by
patients during ambulatory oesophageal pH monitoring or capsule endoscopy.
Hypothesis 2 There is no correlation between physical activity levels and speed of
gastrointestinal transit.
For capsule endoscopy, the investigators are interested in how physical activity affects the
speed of capsule transit through the GI tract. Capsule endoscopy involves a patient
swallowing a pill which contains a camera, in order to image the parts of the bowel that a
conventional endoscope cannot reach. A rapid transit may result in insufficient mucosal
visualisation, which would reduce the sensitivity of the investigation.
For oesophageal pH monitoring, it is essential that the patient behaves as they would
normally to produce measurements that represent a standard day. Using accelerometry, the
investigators can compare the amount, and nature, of physical activity taken throughout the
investigation to that of the preceding day, or week. In addition, further analysis of motion
data captured will allow us to correlate specific activities and body orientation with pH
readings to get a better insight into the pathophysiology of a patient's condition.
The studies will be conducted over 6-9 months in Imperial College Trust's medical outpatient
service. All patients undergoing capsule endoscopy or ambulatory oesophageal monitoring will
be asked to consider participating. Patients will receive the eAR sensor up to 2 days before
their investigation, and will be asked to wear it until the end of their investigation (not
whilst sleeping). Capsule endoscopy normally takes less than 12 hours, and pH monitoring
takes between 24 and 48 hours. Participation makes no difference to the standard or type of
care that they will receive, the sensor data is additional.
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