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

Sponsor
Imperial College London (Other)
Overall Status
Completed
CT.gov ID
NCT02583711
Collaborator
(none)
59
1
24
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Activity sensor (3 axis accelerometer)

Study Design

Study Type:
Observational
Actual Enrollment :
59 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Step Home Trial: Utilising Physical Activity Data in the Acute Post-operative Setting
Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Oct 1, 2017
Actual Study Completion Date :
Oct 1, 2017

Outcome Measures

Primary Outcome Measures

  1. Total Activity Pre-op [2-3 weeks]

  2. Length of Hospital Stay [hospital stay (through hospital stay, approximately to 35 days)]

  3. 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.

  4. 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.

  5. 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.

Secondary Outcome Measures

  1. Number of Participants With Re-admission at Day 30 [30 days after surgery]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St Mary's Hospital London Not In US/Canada United Kingdom W2 1NY

Sponsors and Collaborators

  • Imperial College London

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Imperial College London
ClinicalTrials.gov Identifier:
NCT02583711
Other Study ID Numbers:
  • 15SM2689
  • 15/LO/1038
First Posted:
Oct 22, 2015
Last Update Posted:
Mar 9, 2021
Last Verified:
Feb 1, 2021

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title 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
Arm/Group Description Normal healthy cohort not undergoing colorectal surgical management Patients who underwent colorectal surgery and wore a wearable activity monitor at home pre-operatively and also post-operatively on the ward until discharge Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home.
Period Title: Overall Study
STARTED 11 38 10
COMPLETED 11 28 10
NOT COMPLETED 0 10 0

Baseline Characteristics

Arm/Group Title 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
Arm/Group Description Normal healthy cohort not undergoing colorectal surgical management Patients who underwent colorectal surgery and wore a wearable activity monitor at home pre-operatively and also post-operatively on the ward until discharge Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home. Total of all reporting groups
Overall Participants 11 28 10 49
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
65
(7.26)
67
(11.2)
65
(9.2)
66
(10.2)
Sex: Female, Male (Count of Participants)
Female
6
54.5%
16
57.1%
5
50%
27
55.1%
Male
5
45.5%
12
42.9%
5
50%
22
44.9%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%
Region of Enrollment (participants) [Number]
United Kingdom
11
100%
28
100%
10
100%
49
100%

Outcome Measures

1. Primary Outcome
Title Total Activity Pre-op
Description
Time Frame 2-3 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title 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
Arm/Group Description Normal healthy cohort not undergoing colorectal surgical management Patients who underwent colorectal surgery and wore a wearable activity monitor at home pre-operatively and also post-operatively on the ward until discharge Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home.
Measure Participants 11 28 10
Mean (Standard Deviation) [minutes of activity per 24 hour period]
177
(43)
154
(88)
186
(73)
2. Primary Outcome
Title Length of Hospital Stay
Description
Time Frame hospital stay (through hospital stay, approximately to 35 days)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Patients Wearing WAM Pre-op and Post-op on the Ward Patients Who Wore WAM Pre-op, Post-op on the Ward and Home
Arm/Group Description Patients who underwent colorectal surgery and wore a wearable activity monitor at home pre-operatively and also post-operatively on the ward until discharge Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home.
Measure Participants 28 10
Median (Full Range) [days]
7
8
3. Primary Outcome
Title Time Spent in Light Activity - Pre-op
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title 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
Arm/Group Description Normal healthy cohort not undergoing colorectal surgical management Patients who underwent colorectal surgery and wore a wearable activity monitor at home pre-operatively and also post-operatively on the ward until discharge Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home.
Measure Participants 11 28 10
Mean (Standard Deviation) [minutes of activity per 24 hour period]
95
(24)
75
(41)
87
(38)
4. Primary Outcome
Title Time Spent in Moderate Activity - Preop
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title 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
Arm/Group Description Normal healthy cohort not undergoing colorectal surgical management Patients who underwent colorectal surgery and wore a wearable activity monitor at home pre-operatively and also post-operatively on the ward until discharge Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home.
Measure Participants 11 28 10
Mean (Standard Deviation) [minutes of activity per 24 hour period]
87
(25)
80
(56)
98
(40)
5. Primary Outcome
Title Time Spent in Vigorous Activity - Pre-op
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title 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
Arm/Group Description Normal healthy cohort not undergoing colorectal surgical management Patients who underwent colorectal surgery and wore a wearable activity monitor at home pre-operatively and also post-operatively on the ward until discharge Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home.
Measure Participants 11 28 10
Mean (Standard Deviation) [minutes of activity per 24 hour period]
0
(0)
0
(1)
0
(1)
6. Secondary Outcome
Title Number of Participants With Re-admission at Day 30
Description
Time Frame 30 days after surgery

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Patients Wearing WAM Pre-op and Post-op on the Ward Patients Who Wore WAM Pre-op, Post-op on the Ward and Home
Arm/Group Description Patients who underwent colorectal surgery and wore a wearable activity monitor at home pre-operatively and also post-operatively on the ward until discharge Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home.
Measure Participants 28 10
Count of Participants [Participants]
3
27.3%
1
3.6%
7. Secondary Outcome
Title Number of Participants With Complications up to 6 Weeks Post Discharge
Description
Time Frame up to 6 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Patients Wearing WAM Pre-op and Post-op on the Ward Patients Who Wore WAM Pre-op, Post-op on the Ward and Home
Arm/Group Description Patients who underwent colorectal surgery and wore a wearable activity monitor at home pre-operatively and also post-operatively on the ward until discharge Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home.
Measure Participants 28 10
Count of Participants [Participants]
10
90.9%
4
14.3%

Adverse Events

Time Frame 30 days
Adverse Event Reporting Description
Arm/Group Title 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
Arm/Group Description Normal healthy cohort not undergoing colorectal surgical management Patients who underwent colorectal surgery and wore a wearable activity monitor at home pre-operatively and also post-operatively on the ward until discharge Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home.
All Cause Mortality
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/11 (0%) 0/28 (0%) 0/10 (0%)
Serious Adverse Events
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/11 (0%) 0/28 (0%) 0/10 (0%)
Other (Not Including Serious) Adverse Events
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/11 (0%) 0/28 (0%) 0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Ms Aliza Abeles
Organization Imperial College London
Phone 07834987667
Email aliza.abeles@gmail.com
Responsible Party:
Imperial College London
ClinicalTrials.gov Identifier:
NCT02583711
Other Study ID Numbers:
  • 15SM2689
  • 15/LO/1038
First Posted:
Oct 22, 2015
Last Update Posted:
Mar 9, 2021
Last Verified:
Feb 1, 2021