The Step Home Trial: Utilising Physical Activity Data in the Acute Post-operative Setting

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 Overview

• Status: Completed
• Conditions: Surgery; Technology; Enhanced Recovery
• Intervention / Treatment: Device: Activity sensor (3 axis accelerometer)

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• United Kingdom
  • Not In US/Canada
    • London, Not In US/Canada, United Kingdom, W2 1NY
      • St Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients due for elective surgical procedures will be recruited from outpatient general surgical clinic

Description

Inclusion Criteria:

• Undergoing elective surgical operative procedure

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Activity Pre-op		2-3 weeks
Length of Hospital Stay		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.	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.	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.	2-3 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Re-admission at Day 30	30 days after surgery
Number of Participants With Complications up to 6 Weeks Post Discharge	up to 6 weeks

Collaborators and Investigators

• Sponsor: Imperial College London

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: October 20, 2015
• First Posted (Estimate): October 22, 2015

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 15SM2689; 15/LO/1038 (Other Identifier: NRES London City Road & Hampstead)