Gastro-oesophageal Reflux Disease Clinical Trial
Official title:
An Observational Study to Compare the Outcomes of Ambulatory Gastrointestinal Investigations With Physical Activity Using Accelerometry.
NCT number | NCT01507298 |
Other study ID # | CRO1766 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2012 |
Est. completion date | July 2013 |
Verified date | August 2019 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College Healthcare NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London |
United Kingdom,
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) |
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