NCT03064529

Brief Summary

The present study aims to establish the feasibility of the clinical use of 3-axis accelerometers to measure physical activity in hospitalized children after elective surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P75+ for not_applicable surgery

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable surgery

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

Study Start

First participant enrolled

January 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

2.9 years

First QC Date

February 13, 2017

Last Update Submit

February 20, 2025

Conditions

SurgeryPhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Change in physical activity as measured by accelerometer data

    Continuous measurement beginning 1 week before surgery (when the accelerometer is placed on the wrist) and ending 2 weeks after (when the accelerometer is removed from the wrist)

Study Arms (1)

Accelerometer Participants

EXPERIMENTAL

All participants receive an accelerometer to wear around their wrist to measure physical activity continuously beginning 1 week before surgery (when the accelerometer is put on the wrist) and ending 2 weeks after surgery (when the accelerometer is removed from the wrist).

Behavioral: Accelerometer

Interventions

AccelerometerBEHAVIORAL

All participants receive a wrist worn accelerometer to measure physical activity continuously before and after surgery

Accelerometer Participants

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children ages 3-18 undergoing elective surgery with anticipated overnight hospitalization of at least one day

You may not qualify if:

  • Any children who are non-ambulatory, have any pre-existing mobility limitations, or have a doctor-ordered physical activity limit \>48 hours post surgery. Also, patients with surgery scheduled less than 7 days out as protocol calls for the accelerometer to be worn for 7 days pre-surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Head

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 27, 2017

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

April 1, 2019

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)