N/A N=21

Physical Activity and Gastrointestinal Investigations

Gastro-oesophageal Reflux Disease

Bottom Line

View on ClinicalTrials.gov: NCT01507298 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2019

Primary outcome: Primary: Physical Activity Change (%) — -22 Percentage change in activity

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Imperial College London
Primary completion: Jul 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Physical Activity Change (%)	-22	—
SECONDARY Change in Relative Intensity of Daily Activities (%)	8.5; -1; -1; -6	—

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.

Eligibility Criteria

Inclusion Criteria

Planned 24 hour oesophageal pH monitoring study, or capsule endoscopy

Exclusion Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01507298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.