Physical Activity and Gastrointestinal Investigations

• Sponsor: Imperial College London (Other)
• Overall Status: Completed
• CT.gov ID: NCT01507298
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Actual Duration (Months): 16
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational
• Actual Enrollment: 21 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: An Observational Study to Compare the Outcomes of Ambulatory Gastrointestinal Investigations With Physical Activity Using Accelerometry.
• Actual Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Capsule endoscopy
24 hour oesophageal pH study

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Link to paper showing results of study

Publications

None provided.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT01507298
• Other Study ID Numbers: CRO1766
• First Posted: Jan 10, 2012
• Last Update Posted: Sep 13, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Imperial College London: Physical activity; Accelerometry; Oesophageal pH; Capsule endoscopy
• Additional relevant MeSH terms: Gastroesophageal Reflux

Study Results

Participant Flow

Arm/Group Title	Capsule Endoscopy	24 Hour Oesophageal pH Study
Arm/Group Description	A pill camera used for imaging the small bowel	Patients wore the accelerometer before and during the ambulatory oesophageal pH test for activity levels to be recorded and compared.
Period Title: Overall Study
STARTED	1	20
COMPLETED	1	14
NOT COMPLETED	0	6

Baseline Characteristics

Arm/Group Title	Capsule Endoscopy	24 Hour Oesophageal pH Study	Total
Arm/Group Description	A pill camera used for imaging the small bowel	Patients wore the accelerometer before and during the ambulatory oesophageal pH test for activity levels to be recorded and compared.	Total of all reporting groups
Overall Participants	1	20	21
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	35 (0)	53 (11)	50 (12)
Sex: Female, Male (Count of Participants)
Female	0 0%	10 50%	10 47.6%
Male	1 100%	10 50%	11 52.4%
Region of Enrollment (participants) [Number]
United Kingdom	1 100%	20 100%	21 100%

Outcome Measures

1. Primary Outcome

Title	Physical Activity Change (%)
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Capsule Endoscopy	24 Hour Oesophageal pH Study
Arm/Group Description	A pill camera used for imaging the small bowel.	Patients wore the accelerometer before and during the ambulatory oesophageal pH test for activity levels to be recorded and compared.
Measure Participants	0	13
Mean (Standard Deviation) [Percentage change in activity]	-22 (20)

2. Secondary Outcome

Title	Change in Relative Intensity of Daily Activities (%)
Description	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)

Outcome Measure Data

Analysis Population Description

Raw data captured for capsule endoscopy group not analysed to produce activity metrics due to insufficient numbers recruited (i.e. 1 subject).

Arm/Group Title	Capsule Endoscopy	24 Hour Oesophageal pH Study
Arm/Group Description	A pill camera used for imaging the small bowel	Patients wore the accelerometer before and during the ambulatory oesophageal pH test for activity levels to be recorded and compared.
Measure Participants	0	13
Restful	8.5 (17)
Low	-1 (24)
Moderate	-1 (24)
High	-6 (7)

Adverse Events

Time Frame	2 days
Adverse Event Reporting Description	No adverse events were anticipated from participation in this study.
Arm/Group Title	Capsule Endoscopy		24 Hour Oesophageal pH Study
Arm/Group Description	A pill camera used to image the small bowel.		Patients wore the accelerometer before and during the ambulatory oesophageal pH test for activity levels to be recorded and compared.
All Cause Mortality
	Capsule Endoscopy		24 Hour Oesophageal pH Study
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/20 (0%)
Serious Adverse Events
	Capsule Endoscopy		24 Hour Oesophageal pH Study
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Capsule Endoscopy		24 Hour Oesophageal pH Study
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.