SurgeryNCT02583711
The Step Home Trial: Utilising Physical Activity Data in the Acute Post-operative Setting
An observational study of Surgery and Enhanced Recovery, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This is an observational study, which aims to assess how physical activity levels following surgical procedures correlate with patient recovery and length of hospital stay, as well as the utility of this physical activity data to the postoperative surgical team. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery, Enhanced Recovery, Technology
- What is being tested?
- Activity sensor (3 axis accelerometer)
- Type of treatment
- Medical device
- How many people
- 59 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Oct 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients due for elective surgical procedures will be recruited from outpatient general surgical clinic
Who may be able to join
- Undergoing elective surgical operative procedure
Who cannot join
- Unable to mobilise independently Have medical condition characterized by movement disorder e.g. Parkinson's Disease Unable to understand and complete the SF-36 (unless interpreter present) or lack capacity to consent Psychological Disorder Aged less than 18
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St Mary's Hospital
London, Not in US/Canada, W2 1NY
About this study
This is an observational study, which aims to assess how physical activity levels following surgical procedures correlate with patient recovery and length of hospital stay, as well as the utility of this physical activity data to the postoperative surgical team. Surgical teams frequently enquire about their patients' physical activity levels on postoperative ward rounds. Although this information is often provided anecdotally by nursing staff and junior doctors, there are no objective data made available to the clinician. Such data has the potential to supplement other observations (e.g. heart rate, blood pressure, temperature) to help gain an impression of a patient's recovery and physical status, this in turn could provide evidence to help facilitate early discharge as well as to predict medium to longterm outcomes. Advances in wearable technology allow the investigators to collect detailed information with regard to activity with minimal disruption.
Recent literature has shown that these wristworn sensors can feasibly be worn in hospital pre and postoperatively, with evidence of a correlation between the amount of steps taken postoperatively and the length of hospital stay. This study will provide further evidence for the usability and utility of wearable sensors in the inpatient surgical setting. It will provide supporting evidence for surgeons to confidently analyse and assess patients in hospital, allowing for safe and expedient discharge home as well as identify highrisk patients who are likely to require extra support and surveillance in the community setting.
- Conditions
- Surgery, Enhanced Recovery, Technology
- Being tested
- Activity sensor (3 axis accelerometer)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity sensor (3 axis accelerometer)Device
Patient cohort will wear the activity sensor from pre-admission clinic until discharge after surgical procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Activity Pre-op
Measured: 2-3 weeks
Length of Hospital Stay
Measured: hospital stay (through hospital stay, approximately to 35 days)
Time Spent in Light Activity - Pre-op
Signal vector magnitude (SVM) and cut point analysis algorithms are used with the tri-axial accelerometer data to quantify activity into sedentary, light, moderate and vigorous activity.
The time spent in the different activity levels was analysed from the recorded accelerometer data and analysed.
Measured: 2-3 weeks
Time Spent in Moderate Activity - Preop
Signal vector magnitude (SVM) and cut point analysis algorithms are used with the tri-axial accelerometer data to quantify activity into sedentary, light, moderate and vigorous activity.
The time spent in the different activity levels was analysed from the recorded accelerometer data and analysed.
Measured: 2-3 weeks
Time Spent in Vigorous Activity - Pre-op
Signal vector magnitude (SVM) and cut point analysis algorithms are used with the tri-axial accelerometer data to quantify activity into sedentary, light, moderate and vigorous activity.
The time spent in the different activity levels was analysed from the recorded accelerometer data and analysed.
Measured: 2-3 weeks
Secondary outcomes (2)
Number of Participants With Re-admission at Day 30
Measured: 30 days after surgery
Number of Participants With Complications up to 6 Weeks Post Discharge
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583711
- Sponsor's protocol ID
- 15SM2689
- Other IDs
- 15/LO/1038
- Status last verified
- Feb 2021
- First submitted
- 30 Sep 2015
- Last updated
- 9 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Step Home Trial: Utilising Physical Activity Data in the Acute Post-operative Setting
- ClinicalTrials.gov ID
- NCT02583711
- Acronym / sponsor ID
- 15SM2689
- Conditions
- Surgery, Enhanced Recovery, Technology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Posted 9 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study, which aims to assess how physical activity levels following surgical procedures correlate with patient recovery and length of hospital stay, as well as the utility of this physical activity data to the postoperative surgical team. Surgical teams frequently enquire about their patients' physical activity levels on postoperative ward rounds. Although this information is often provided anecdotally by nursing staff and junior doctors, there are no objective data made available to the clinician. Such data has the potential to supplement other observations (e.g. heart rate, blood pressure, temperature) to help gain an impression of a patient's recovery and physical status, this in turn could provide evidence to help facilitate early discharge as well as to predict medium to longterm outcomes. Advances in wearable technology allow the investigators to collect detailed information with regard to activity with minimal disruption.
Recent literature has shown that these wristworn sensors can feasibly be worn in hospital pre and postoperatively, with evidence of a correlation between the amount of steps taken postoperatively and the length of hospital stay. This study will provide further evidence for the usability and utility of wearable sensors in the inpatient surgical setting. It will provide supporting evidence for surgeons to confidently analyse and assess patients in hospital, allowing for safe and expedient discharge home as well as identify highrisk patients who are likely to require extra support and surveillance in the community setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients due for elective surgical procedures will be recruited from outpatient general surgical clinic
Key inclusion criteria (1 listed)
- Undergoing elective surgical operative procedure
Key exclusion criteria (1 listed)
- Unable to mobilise independently Have medical condition characterized by movement disorder e.g. Parkinson's Disease Unable to understand and complete the SF-36 (unless interpreter present) or lack capacity to consent Psychological Disorder Aged less than 18
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 |
|---|---|---|
| Activity sensor (3 axis accelerometer)Patient cohort will wear the activity sensor from pre-admission clinic until discharge after surgical procedure | Device | – |
Primary outcome
Total Activity Pre-op
Time frame: 2-3 weeks
Length of Hospital Stay
Time frame: hospital stay (through hospital stay, approximately to 35 days)
Time Spent in Light Activity - Pre-op
Time frame: 2-3 weeks
Signal vector magnitude (SVM) and cut point analysis algorithms are used with the tri-axial accelerometer data to quantify activity into sedentary, light, moderate and vigorous activity. The time spent in the different activity levels was analysed from the recorded accelerometer data and analysed.
Time Spent in Moderate Activity - Preop
Time frame: 2-3 weeks
Signal vector magnitude (SVM) and cut point analysis algorithms are used with the tri-axial accelerometer data to quantify activity into sedentary, light, moderate and vigorous activity. The time spent in the different activity levels was analysed from the recorded accelerometer data and analysed.
Time Spent in Vigorous Activity - Pre-op
Time frame: 2-3 weeks
Signal vector magnitude (SVM) and cut point analysis algorithms are used with the tri-axial accelerometer data to quantify activity into sedentary, light, moderate and vigorous activity. The time spent in the different activity levels was analysed from the recorded accelerometer data and analysed.
2 secondary outcomes
Number of Participants With Re-admission at Day 30
Time frame: 30 days after surgery
Number of Participants With Complications up to 6 Weeks Post Discharge
Time frame: up to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Surgery
Not yet recruiting
The Contribution of Accelerated Recovery (mERAS) Approach to Postoperative Recovery in Pediatric Laparoscopic Surgery Cases
mERAS Intervention, The ASA (American Society of Anesthesiologists) Score
RecruitingObservational study
Label-free Femtosecond Laser Imaging Combined With the Fast Lung Artificial Intelligence Model for Rapid Intraoperative Diagnosis of Lung Surgical Specimens: A Multicentre, Prospective, Parallel-workflow, Non-inferiority Study.
Lung Cancer
RecruitingPhase 3
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
Ganglioneuroblastoma, Nodular, Neuroblastoma
Not yet recruiting
The Effect of Compound Chamomile and Lidocaine Hydronchloride Gel as an Endotracheal Tube Lubricant on Postoperative Pharyngeal and Laryngeal Complications in Thoracic Surgery Patients
Postoperative Sore Throat
Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
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?
An observational study of Surgery and Enhanced Recovery, run by Imperial College London at 1 site in United Kingdom.
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 9 Mar 2021. 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 Kingdom. 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?
Yes. Results are posted in the registry (first posted 9 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Activity Pre-op (time frame: 2-3 weeks). The study lists 5 primary outcomes in all. 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 9 Mar 2021; AzTrials last refreshed its copy on 26 Oct 2026.