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SurgeryNCT03064529

A Novel Approach to Inpatient Pediatric Physical Activity Measurement - The 6th Vital Sign

A study testing Accelerometer in people with Surgery and Physical Activity, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Surgery, Physical Activity
What is being tested?
Accelerometer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
175 participants
Where
1 siteUnited States
Study dates
1 Jan 2016to Apr 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Ann & Robert H. Lurie Children's Hospital

    Chicago, Illinois, 60611

Other trials in United States

About this study

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.

Read the detailed description

Purpose:

A nearly universal aspect of hospitalization is a loss of physical activity due to confinement to bed, deconditioning, respiratory compromise, and pain with recovery comprising multifactorial components such as the return to activity, adequate pain control, and overall neurologic function. Assessment of recovery from surgery and the ability to return to full, normal activity has previously been dependent upon subjective clinical evaluation that are subject to observer-to-observer variability, selection bias, or variable interpretation of the qualitative description of movement. Bedside assessments utilizing an accelerometer could change clinical practice by having readily available, quantifiable, reliable and highly accurate data for healthcare providers when they make day-to-day decisions of medical care, as. The present study aims to establish the feasibility of the clinical use of 3-axis accelerometers to measure physical activity in the hospitalized children after abdominal surgery.

Methods:

Participants:

The target study population will be 25 English- or Spanish-speaking children ages 3-18 undergoing elective abdominal surgery with anticipated overnight hospitalization of at least one day. Children must be freely ambulatory without any pre-existing mobility-limitations. Study enrollment and recruitment will occur in Lurie outpatient urology and pediatric surgery clinics over a 6 month period. Parental/guardian consent will be obtained at the preoperative clinical visit.

Accelerometers Actigraph accelerometers (model GT3X; Pensacola, FL) will be obtained from Lurie Consortium to Lower Obesity in Chicago Children (CLOCC). Study participants will be asked to wear accelerometers at the same location throughout the study period unless there is a contraindication to maintain the same location and requires relocation (e.g. interference by IV access). Location preference is the wrist. Patients will wear accelerometers continuously (except for when bathing) for 7 days prior to surgery, the accelerometer will be removed for the operation and placed back on the patient immediately after the operation through 14 days postoperative. Accelerometers will be mailed to children 10 days preoperatively for those whose surgeries are scheduled >2 weeks from preoperative clinic visit along with a return envelop for return of the accelerometer postoperatively; those children who are scheduled for surgery within 2 weeks of their preoperative clinic visit will be provided accelerometers at that clinic visit. Accelerometers will be returned at postoperative clinic visit if within 8 days after surgery or mailed back if postoperative clinic visit is more than 8 days postoperative. Actigraph software will be purchased and will allow preprogramming of accelerometers to begin collection of data 1 week prior to planned surgery date. Reminder phone calls will be placed remind patients to start wearing accelerometers 1 week prior to surgery. Accelerometer movement count data epoch will be measured at 5-second intervals.

Being tested
Accelerometer
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AccelerometerBehavioural

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

Study groups in NCT03064529
Study groupRoleWhat they receive
Accelerometer ParticipantsExperimentalAll 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).
Receives: Behavioral: Accelerometer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in physical activity as measured by accelerometer data

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2017
  2. Study start1 Jan 2016
  3. Primary completion1 Dec 2018
  4. Study completionApr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03064529
Sponsor's protocol ID
2015-734
Status last verified
Feb 2025
First submitted
13 Feb 2017
Last updated
24 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Accelerometer in people with Surgery and Physical Activity, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in physical activity as measured by accelerometer data (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.

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