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Completed

NCT Number: NCT02583711

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Mary's Hospital

London, Not in US/Canada, W2 1NY, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Activity sensor (3 axis accelerometer)

Device

Patient cohort will wear the activity sensor from pre-admission clinic until discharge after surgical procedure

Primary outcomes

  1. Total Activity Pre-op

    Time frame: 2-3 weeks

  2. Length of Hospital Stay

    Time frame: hospital stay (through hospital stay, approximately to 35 days)

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Number of Participants With Re-admission at Day 30

    Time frame: 30 days after surgery

  2. Number of Participants With Complications up to 6 Weeks Post Discharge

    Time frame: up to 6 weeks

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 22, 2015
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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