Trial Outcomes & Findings for Physical Activity and Gastrointestinal Investigations (NCT NCT01507298)
NCT ID: NCT01507298
Last Updated: 2019-09-13
Results Overview
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.
COMPLETED
21 participants
Difference between baseline (2 days average) and test day (during pH monitoring)
2019-09-13
Participant Flow
Participant milestones
| Measure |
Capsule Endoscopy
A pill camera used for imaging the small bowel
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
20
|
|
Overall Study
COMPLETED
|
1
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
6
|
Reasons for withdrawal
| Measure |
Capsule Endoscopy
A pill camera used for imaging the small bowel
|
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
6
|
Baseline Characteristics
Physical Activity and Gastrointestinal Investigations
Baseline characteristics by cohort
| Measure |
Capsule Endoscopy
n=1 Participants
A pill camera used for imaging the small bowel
|
24 Hour Oesophageal pH Study
n=20 Participants
Patients wore the accelerometer before and during the ambulatory oesophageal pH test for activity levels to be recorded and compared.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 Years
STANDARD_DEVIATION 0 • n=5 Participants
|
53 Years
STANDARD_DEVIATION 11 • n=7 Participants
|
50 Years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
20 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Capsule Endoscopy
A pill camera used for imaging the small bowel.
|
24 Hour Oesophageal pH Study
n=13 Participants
Patients wore the accelerometer before and during the ambulatory oesophageal pH test for activity levels to be recorded and compared.
|
|---|---|---|
|
Physical Activity Change (%)
|
—
|
-22 Percentage change in activity
Standard Deviation 20
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Capsule Endoscopy
A pill camera used for imaging the small bowel.
|
24 Hour Oesophageal pH Study
n=13 Participants
Patients wore the accelerometer before and during the ambulatory oesophageal pH test for activity levels to be recorded and compared.
|
|---|---|---|
|
Change in Relative Intensity of Daily Activities (%)
Restful
|
—
|
8.5 Percentage change in activity
Standard Deviation 17
|
|
Change in Relative Intensity of Daily Activities (%)
Low
|
—
|
-1 Percentage change in activity
Standard Deviation 24
|
|
Change in Relative Intensity of Daily Activities (%)
Moderate
|
—
|
-1 Percentage change in activity
Standard Deviation 24
|
|
Change in Relative Intensity of Daily Activities (%)
High
|
—
|
-6 Percentage change in activity
Standard Deviation 7
|
Adverse Events
Capsule Endoscopy
24 Hour Oesophageal pH Study
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place