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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Surgery, Physical Activity
- 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 group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Accelerometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted27 Feb 2017
- Study start1 Jan 2016
- Primary completion1 Dec 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fizan Abdullah, MD, Ann & Robert H Lurie Children's Hospital of Chicago
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach to Inpatient Pediatric Physical Activity Measurement - The 6th Vital Sign
- ClinicalTrials.gov ID
- NCT03064529
- Acronym / sponsor ID
- 2015-734
- Conditions
- Surgery, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 27 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accelerometer Participants | Experimental | Behavioral: AccelerometerAll 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). |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children ages 3-18 undergoing elective surgery with anticipated overnight hospitalization of at least one day
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccelerometerAll participants receive a wrist worn accelerometer to measure physical activity continuously before and after surgery | Behavioural | Accelerometer Participants |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.