Physical Activity and Gastrointestinal Investigations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01507298
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : December 12, 2014
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

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.

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.

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.

Condition or disease
Gastro-oesophageal Reflux Disease

Study Type : Observational
Actual Enrollment : 30 participants
Time Perspective: Prospective
Official Title: An Observational Study to Compare the Outcomes of Ambulatory Gastrointestinal Investigations With Physical Activity Using Accelerometry.
Study Start Date : March 2012
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Capsule endoscopy
24 hour oesophageal pH study

Primary Outcome Measures :
  1. Physical activity [ Time Frame: 5 Days per patient ]
    The primary outcome measure is amount of physical activity undertaken by participants throughout the study period. Participant motion data will be collected using a tri-axial accelerometer in the eAR sensor. Signal processing methods will be used to produce an activity index in the form of a numerical value, from the raw data.

Secondary Outcome Measures :
  1. Subgroup analysis and vertical orientation [ Time Frame: 5 Days per patient ]
    Secondary outcome measurements will be produced through further processing of the raw data. This includes firstly breaking physical activity down into sub groups, i.e. low, moderate, and high intensity exercise undertaken. Secondly, we will produce a third outcome measurement by calculating the variation in vertical orientation of participants throughout the study period using two the constant influence of gravity on two of the axes of the accelerometer.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Those who have been advised to undergo 24 hour oesophageal pH monitoring, or capsule endoscopy (from GI outpatients clinic)

Inclusion Criteria:

  • Planned 24 hour oesophageal pH monitoring study, or capsule endoscopy

Exclusion Criteria:

  1. Undergone previous capsule endoscopy or ambulatory oesophageal pH test
  2. Currently a hospital in-patient
  3. Severe mobility disorder (unable to walk or mobilise independently)
  4. Age less than 18 or above 65
  5. Physically unable to wear eAR sensor (eg. bilateral hearing aids or particularly small ears)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01507298

United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Principal Investigator: Richard M Kwasnicki, BSc Hons Imperial College London

Responsible Party: Imperial College London Identifier: NCT01507298     History of Changes
Other Study ID Numbers: CRO1766
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: March 2013

Keywords provided by Imperial College London:
Physical activity
Oesophageal pH
Capsule endoscopy

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases