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

Completed

• Conditions: Enhanced Recovery; Surgery; Technology

• Registration Number: NCT02583711
• Lead Sponsor: Imperial College London

Brief 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. 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-09-30
• Study Start: 2015-10
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-22
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Results First Submitted: 2021-01-25
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-17
• Last Update Submitted: 2021-02-17
• Results First Posted: 2021-03-09
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Undergoing elective surgical operative procedure

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

St Mary's Hospital; 🇬🇧 London, Not In US/Canada, United Kingdom