Physical Activity and Gastrointestinal Investigations

NCT ID: NCT01507298

Last Updated: 2019-09-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-07-31

Brief Summary

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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

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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.

Conditions

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Gastro-oesophageal Reflux Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Capsule endoscopy

No interventions assigned to this group

24 hour oesophageal pH study

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard M Kwasnicki, BSc Hons

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 25625191 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/25625191

Link to paper showing results of study

Other Identifiers

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CRO1766

Identifier Type: -

Identifier Source: org_study_id

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