NCT01507298

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
6.2 years until next milestone

Results Posted

Study results publicly available

September 13, 2019

Completed
Last Updated

September 13, 2019

Status Verified

August 1, 2019

Enrollment Period

1.3 years

First QC Date

January 6, 2012

Results QC Date

September 11, 2015

Last Update Submit

August 7, 2019

Conditions

Gastro-oesophageal Reflux Disease

Keywords

Physical activityAccelerometryOesophageal pHCapsule endoscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in Relative Intensity of Daily Activities (%)

    Difference between baseline (2 days average) and test day (during pH monitoring)

Study Arms (2)

Capsule endoscopy

24 hour oesophageal pH study

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those who have been advised to undergo 24 hour oesophageal pH monitoring, or capsule endoscopy (from GI outpatients clinic)

You may qualify if:

  • Planned 24 hour oesophageal pH monitoring study, or capsule endoscopy

You may not qualify if:

  • Undergone previous capsule endoscopy or ambulatory oesophageal pH test
  • Currently a hospital in-patient
  • Severe mobility disorder (unable to walk or mobilise independently)
  • Age less than 18 or above 65
  • Physically unable to wear eAR sensor (eg. bilateral hearing aids or particularly small ears)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 25625191RESULT

Related Links

MeSH Terms

Conditions

Gastroesophageal RefluxMotor Activity

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesBehavior

Results Point of Contact

Title
Dr. Richard Mark Kwasnicki
Organization
Imperial College London
rmk107@ic.ac.uk
07851759471

Study Officials

  • Richard M Kwasnicki, BSc Hons

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2012

First Posted

January 10, 2012

Study Start

March 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

September 13, 2019

Results First Posted

September 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)