Clinical trial NCT02583711: The Step Home Trial: Utilising Physical Activity Data in the Acute Post-operative Setting
Official title: The Step Home Trial: Utilising Physical Activity Data in the Acute Post-operative Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Enhanced Recovery
Technology
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients due for elective surgical procedures will be recruited from outpatient general surgical clinic

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.


Eligibility criteria: 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

Primary outcomes:
measure: Total Activity Pre-op
timeFrame: 2-3 weeks
measure: Length of Hospital Stay
timeFrame: hospital stay (through hospital stay, approximately to 35 days)
measure: Time Spent in Light Activity - Pre-op
timeFrame: 2-3 weeks
measure: Time Spent in Moderate Activity - Preop
timeFrame: 2-3 weeks
measure: Time Spent in Vigorous Activity - Pre-op
timeFrame: 2-3 weeks
Secondary outcomes:
measure: Number of Participants With Re-admission at Day 30
timeFrame: 30 days after surgery
measure: Number of Participants With Complications up to 6 Weeks Post Discharge
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Mary's Hospital
state: Not In US/Canada
Study officials:
References: