Physical Activity and Gastrointestinal Investigations

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01507298
First received: January 6, 2012
Last updated: March 27, 2013
Last verified: March 2013

January 6, 2012
March 27, 2013
March 2012
July 2013   (final data collection date for primary outcome measure)
Physical activity [ Time Frame: 5 Days per patient ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01507298 on ClinicalTrials.gov Archive Site
Subgroup analysis and vertical orientation [ Time Frame: 5 Days per patient ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Physical Activity and Gastrointestinal Investigations
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.

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Those who have been advised to undergo 24 hour oesophageal pH monitoring, or capsule endoscopy (from GI outpatients clinic)

Gastro-oesophageal Reflux Disease
Not Provided
  • Capsule endoscopy
  • 24 hour oesophageal pH study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
Not Provided
July 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01507298
CRO1766
No
Imperial College London
Imperial College London
Not Provided
Principal Investigator: Richard M Kwasnicki, BSc Hons Imperial College London
Imperial College London
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP