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

NCT02583711 | Completed Results

• 2 other identifiers: 15SM268915/LO/1038
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Enhanced Recovery; Technology

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• 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

Interventions

Activity sensor (3 axis accelerometer) DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Undergoing elective surgical operative procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

St Mary's Hospital

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

Location

Results Point of Contact

• Title: Ms Aliza Abeles
• Organization: Imperial College London

aliza.abeles@gmail.com

07834987667

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 22, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 9, 2021
• Results First Posted: March 9, 2021

Record last verified: 2021-02

Locations

GB (1)