NCT03328039

Brief Summary

This is an observational, non-interventional study to assess the equivalence of wearable monitors with formal CPET testing for the prediction of physiological reserve before major surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2017

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

December 8, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
9 months until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

May 20, 2019

Status Verified

February 1, 2018

Enrollment Period

1.9 years

First QC Date

December 8, 2016

Last Update Submit

May 17, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Successful recoding of accelerometer data

    Successful recoding of accelerometer data

    7 days

Interventions

Physiological data capture only

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Recently, low-cost, wearable activity monitors have become very popular. They can record lots of information about a person's general health and activity. In this study, we would like to see if an activity monitor can help predict a person's risk of developing complications after having major surgery.

You may qualify if:

  • Aged 18 years or older with capacity to consent
  • Clinical indications for planned CPET testing before planned major elective surgery

You may not qualify if:

  • Atrial fibrillation
  • Nickel allergy
  • Unable to wear a watch
  • Unable to conduct CPET
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

Location

Related Publications (1)

  • Jones L, Tan L, Carey-Jones S, Riddell N, Davies R, Brownsdon A, Kelson M, Williams-Thomas R, Busse M, Davies MM, Morgan MPG. Can wearable technology be used to approximate cardiopulmonary exercise testing metrics? Perioper Med (Lond). 2021 Mar 16;10(1):9. doi: 10.1186/s13741-021-00180-w.

Study Officials

  • Matt Morgan, PhD

    Cardiff University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 8, 2016

First Posted

November 1, 2017

Study Start

February 1, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

May 20, 2019

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

Only on request.

Locations