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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
History of Changes
  Purpose

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
Gastro-oesophageal Reflux Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Observational Study to Compare the Outcomes of Ambulatory Gastrointestinal Investigations With Physical Activity Using Accelerometry.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: March 2012
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Capsule endoscopy
24 hour oesophageal pH study

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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)

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507298

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

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01507298     History of Changes
Other Study ID Numbers: CRO1766
Study First Received: January 6, 2012
Last Updated: March 27, 2013
Health Authority: United Kingdom: National Health Service

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

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

ClinicalTrials.gov processed this record on May 21, 2013