Enhanced Recovery, Surgery, Technology
Conditions
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.
Interventions
DEVICEActivity sensor (3 axis accelerometer)
Patient cohort will wear the activity sensor from pre-admission clinic until discharge after surgical procedure
Sponsors
Imperial College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | hospital stay (through hospital stay, approximately to 35 days) | — |
| 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. |
| Total Activity Pre-op | 2-3 weeks | — |
| 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. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Complications up to 6 Weeks Post Discharge | up to 6 weeks |
| Number of Participants With Re-admission at Day 30 | 30 days after surgery |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Cohort Normal healthy cohort not undergoing colorectal surgical management | 11 |
| Patients Wearing WAM Pre-op and Post-op on the Ward Patients who underwent colorectal surgery and wore a wearable activity monitor at home pre-operatively and also post-operatively on the ward until discharge | 28 |
| Patients Who Wore WAM Pre-op, Post-op on the Ward and Home Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home. | 10 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 10 | 0 |
Baseline characteristics
| Characteristic | Healthy Cohort | Patients Wearing WAM Pre-op and Post-op on the Ward | Patients Who Wore WAM Pre-op, Post-op on the Ward and Home | Total |
|---|---|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 7.26 | 67 years STANDARD_DEVIATION 11.2 | 65 years STANDARD_DEVIATION 9.2 | 66 years STANDARD_DEVIATION 10.2 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United Kingdom | 11 participants | 28 participants | 10 participants | 49 participants |
| Sex: Female, Male Female | 6 Participants | 16 Participants | 5 Participants | 27 Participants |
| Sex: Female, Male Male | 5 Participants | 12 Participants | 5 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 28 | 0 / 10 |
| other Total, other adverse events | 0 / 11 | 0 / 28 | 0 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 28 | 0 / 10 |
Outcome results
Primary
Length of Hospital Stay
Time frame: hospital stay (through hospital stay, approximately to 35 days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Cohort | Length of Hospital Stay | 7 days |
| Patients Wearing WAM Pre-op and Post-op on the Ward | Length of Hospital Stay | 8 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.
Time frame: 2-3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Cohort | Time Spent in Light Activity - Pre-op | 95 minutes of activity per 24 hour period | Standard Deviation 24 |
| Patients Wearing WAM Pre-op and Post-op on the Ward | Time Spent in Light Activity - Pre-op | 75 minutes of activity per 24 hour period | Standard Deviation 41 |
| Patients Who Wore WAM Pre-op, Post-op on the Ward and Home | Time Spent in Light Activity - Pre-op | 87 minutes of activity per 24 hour period | Standard Deviation 38 |
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.
Time frame: 2-3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Cohort | Time Spent in Moderate Activity - Preop | 87 minutes of activity per 24 hour period | Standard Deviation 25 |
| Patients Wearing WAM Pre-op and Post-op on the Ward | Time Spent in Moderate Activity - Preop | 80 minutes of activity per 24 hour period | Standard Deviation 56 |
| Patients Who Wore WAM Pre-op, Post-op on the Ward and Home | Time Spent in Moderate Activity - Preop | 98 minutes of activity per 24 hour period | Standard Deviation 40 |
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.
Time frame: 2-3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Cohort | Time Spent in Vigorous Activity - Pre-op | 0 minutes of activity per 24 hour period | Standard Deviation 0 |
| Patients Wearing WAM Pre-op and Post-op on the Ward | Time Spent in Vigorous Activity - Pre-op | 0 minutes of activity per 24 hour period | Standard Deviation 1 |
| Patients Who Wore WAM Pre-op, Post-op on the Ward and Home | Time Spent in Vigorous Activity - Pre-op | 0 minutes of activity per 24 hour period | Standard Deviation 1 |
Primary
Total Activity Pre-op
Time frame: 2-3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Cohort | Total Activity Pre-op | 177 minutes of activity per 24 hour period | Standard Deviation 43 |
| Patients Wearing WAM Pre-op and Post-op on the Ward | Total Activity Pre-op | 154 minutes of activity per 24 hour period | Standard Deviation 88 |
| Patients Who Wore WAM Pre-op, Post-op on the Ward and Home | Total Activity Pre-op | 186 minutes of activity per 24 hour period | Standard Deviation 73 |
Secondary
Number of Participants With Complications up to 6 Weeks Post Discharge
Time frame: up to 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Cohort | Number of Participants With Complications up to 6 Weeks Post Discharge | 10 Participants |
| Patients Wearing WAM Pre-op and Post-op on the Ward | Number of Participants With Complications up to 6 Weeks Post Discharge | 4 Participants |
Secondary
Number of Participants With Re-admission at Day 30
Time frame: 30 days after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Cohort | Number of Participants With Re-admission at Day 30 | 3 Participants |
| Patients Wearing WAM Pre-op and Post-op on the Ward | Number of Participants With Re-admission at Day 30 | 1 Participants |