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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02583711
• Other study ID #: 15SM2689
• Secondary ID: 15/LO/1038
• Status: Completed
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: February 2021
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enhanced Recovery
• Surgery
• Technology

Intervention

Device:
• Activity sensor (3 axis accelerometer)
Patient cohort will wear the activity sensor from pre-admission clinic until discharge after surgical procedure

Locations

Country	Name	City	State
United Kingdom	St Mary's Hospital	London	Not In US/Canada

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Activity Pre-op		2-3 weeks
Primary	Length of Hospital Stay		hospital stay (through hospital stay, approximately to 35 days)
Primary	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
Primary	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
Primary	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	Number of Participants With Re-admission at Day 30		30 days after surgery
Secondary	Number of Participants With Complications up to 6 Weeks Post Discharge		up to 6 weeks