Gastro-oesophageal Reflux Disease
Conditions
Keywords
Physical activity, Accelerometry, Oesophageal pH, Capsule endoscopy
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. 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.
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.
Interventions
None listed
Sponsors
Imperial College London
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity Change (%) | Difference between baseline (2 days average) and test day (during pH monitoring) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Relative Intensity of Daily Activities (%) | Difference between baseline (2 days average) and test day (during pH monitoring) | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Capsule Endoscopy A pill camera used for imaging the small bowel | 1 |
| 24 Hour Oesophageal pH Study Patients wore the accelerometer before and during the ambulatory oesophageal pH test for activity levels to be recorded and compared. | 20 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 6 |
Baseline characteristics
| Characteristic | Capsule Endoscopy | 24 Hour Oesophageal pH Study | Total |
|---|---|---|---|
| Age, Continuous | 35 Years STANDARD_DEVIATION 0 | 53 Years STANDARD_DEVIATION 11 | 50 Years STANDARD_DEVIATION 12 |
| Region of Enrollment United Kingdom | 1 participants | 20 participants | 21 participants |
| Sex: Female, Male Female | 0 Participants | 10 Participants | 10 Participants |
| Sex: Female, Male Male | 1 Participants | 10 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 20 |
| other Total, other adverse events | 0 / 1 | 0 / 20 |
| serious Total, serious adverse events | 0 / 1 | 0 / 20 |
Outcome results
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.
Time frame: Difference between baseline (2 days average) and test day (during pH monitoring)
Population: Due to significant differences in expected and actual recruitment for the capsule endoscopy arm (i.e. 1 subject), raw data collected were not analysed to produce activity metrics.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 24 Hour Oesophageal pH Study | Physical Activity Change (%) | -22 Percentage change in activity | Standard Deviation 20 |
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.
Time frame: Difference between baseline (2 days average) and test day (during pH monitoring)
Population: Raw data captured for capsule endoscopy group not analysed to produce activity metrics due to insufficient numbers recruited (i.e. 1 subject).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 24 Hour Oesophageal pH Study | Change in Relative Intensity of Daily Activities (%) | Restful | 8.5 Percentage change in activity | Standard Deviation 17 |
| 24 Hour Oesophageal pH Study | Change in Relative Intensity of Daily Activities (%) | Low | -1 Percentage change in activity | Standard Deviation 24 |
| 24 Hour Oesophageal pH Study | Change in Relative Intensity of Daily Activities (%) | Moderate | -1 Percentage change in activity | Standard Deviation 24 |
| 24 Hour Oesophageal pH Study | Change in Relative Intensity of Daily Activities (%) | High | -6 Percentage change in activity | Standard Deviation 7 |