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.

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.

Study Overview

• Status: Completed
• Conditions: Gastro-oesophageal Reflux Disease

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W2 1NY
    • Imperial College Healthcare NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Capsule endoscopy
24 hour oesophageal pH study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Change (%)	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. Activity levels were grouped at 1- minute intervals into restful, low, moderate or high intensity activity. Activity levels were calibrated for each participant, classifying activity into quartiles, where the most inactivity was labelled 'Restful', 2nd quartile 'low intensity', 3rd quartile 'moderate intensity' and upper quartile 'high intensity'. This provided a personalised activity profile with which to compare activity during the investigation.	Difference between baseline (2 days average) and test day (during pH monitoring)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Relative Intensity of Daily Activities (%)	Measuring the changes in restful (activity equivalent to sitting), low (activity equivalent to a slow walk), moderate (activity equivalent to a brisk walk) and high intensity activity (activity equivalent to running). Including subject-specific activity intensity quartiles, were calculated and compared.	Difference between baseline (2 days average) and test day (during pH monitoring)

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Richard M Kwasnicki, BSc Hons, Imperial College London

Publications and helpful links

General Publications

• Kwasnicki RM, Ley Greaves R, Ali R, Gummett PA, Yang GZ, Darzi A, Hoare J. Implementation of objective activity monitoring to supplement the interpretation of ambulatory esophageal PH investigations. Dis Esophagus. 2016 Apr;29(3):255-61. doi: 10.1111/dote.12312. Epub 2015 Jan 27.

Helpful Links

• Link to paper showing results of study

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: January 6, 2012
• First Submitted That Met QC Criteria: January 9, 2012
• First Posted (Estimate): January 10, 2012

Study Record Updates

• Last Update Posted (Actual): September 13, 2019
• Last Update Submitted That Met QC Criteria: August 7, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Physical activity; Accelerometry; Capsule endoscopy; Oesophageal pH
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: CRO1766

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No