Trial Outcomes & Findings for The Step Home Trial: Utilising Physical Activity Data in the Acute Post-operative Setting (NCT NCT02583711)
NCT ID: NCT02583711
Last Updated: 2021-03-09
Results Overview
Recruitment status
COMPLETED
Target enrollment
59 participants
Primary outcome timeframe
2-3 weeks
Results posted on
2021-03-09
Participant Flow
Participant milestones
| Measure |
Healthy Cohort
Normal healthy cohort not undergoing colorectal surgical management
|
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
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
38
|
10
|
|
Overall Study
COMPLETED
|
11
|
28
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
10
|
0
|
Reasons for withdrawal
| Measure |
Healthy Cohort
Normal healthy cohort not undergoing colorectal surgical management
|
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
|
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
10
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Healthy Cohort
n=11 Participants
Normal healthy cohort not undergoing colorectal surgical management
|
Patients Wearing WAM Pre-op and Post-op on the Ward
n=28 Participants
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 Wore WAM Pre-op, Post-op on the Ward and Home
n=10 Participants
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
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 7.26 • n=11 Participants
|
67 years
STANDARD_DEVIATION 11.2 • n=28 Participants
|
65 years
STANDARD_DEVIATION 9.2 • n=10 Participants
|
66 years
STANDARD_DEVIATION 10.2 • n=49 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=11 Participants
|
16 Participants
n=28 Participants
|
5 Participants
n=10 Participants
|
27 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=11 Participants
|
12 Participants
n=28 Participants
|
5 Participants
n=10 Participants
|
22 Participants
n=49 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
11 participants
n=11 Participants
|
28 participants
n=28 Participants
|
10 participants
n=10 Participants
|
49 participants
n=49 Participants
|
PRIMARY outcome
Timeframe: 2-3 weeksOutcome measures
| Measure |
Healthy Cohort
n=11 Participants
Normal healthy cohort not undergoing colorectal surgical management
|
Patients Wearing WAM Pre-op and Post-op on the Ward
n=28 Participants
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 Wore WAM Pre-op, Post-op on the Ward and Home
n=10 Participants
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 Activity Pre-op
|
177 minutes of activity per 24 hour period
Standard Deviation 43
|
154 minutes of activity per 24 hour period
Standard Deviation 88
|
186 minutes of activity per 24 hour period
Standard Deviation 73
|
PRIMARY outcome
Timeframe: hospital stay (through hospital stay, approximately to 35 days)Outcome measures
| Measure |
Healthy Cohort
n=28 Participants
Normal healthy cohort not undergoing colorectal surgical management
|
Patients Wearing WAM Pre-op and Post-op on the Ward
n=10 Participants
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 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.
|
|---|---|---|---|
|
Length of Hospital Stay
|
7 days
Interval 3.0 to 33.0
|
8 days
Interval 4.0 to 13.0
|
—
|
PRIMARY outcome
Timeframe: 2-3 weeksSignal 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.
Outcome measures
| Measure |
Healthy Cohort
n=11 Participants
Normal healthy cohort not undergoing colorectal surgical management
|
Patients Wearing WAM Pre-op and Post-op on the Ward
n=28 Participants
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 Wore WAM Pre-op, Post-op on the Ward and Home
n=10 Participants
Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home.
|
|---|---|---|---|
|
Time Spent in Light Activity - Pre-op
|
95 minutes of activity per 24 hour period
Standard Deviation 24
|
75 minutes of activity per 24 hour period
Standard Deviation 41
|
87 minutes of activity per 24 hour period
Standard Deviation 38
|
PRIMARY outcome
Timeframe: 2-3 weeksSignal 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.
Outcome measures
| Measure |
Healthy Cohort
n=11 Participants
Normal healthy cohort not undergoing colorectal surgical management
|
Patients Wearing WAM Pre-op and Post-op on the Ward
n=28 Participants
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 Wore WAM Pre-op, Post-op on the Ward and Home
n=10 Participants
Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home.
|
|---|---|---|---|
|
Time Spent in Moderate Activity - Preop
|
87 minutes of activity per 24 hour period
Standard Deviation 25
|
80 minutes of activity per 24 hour period
Standard Deviation 56
|
98 minutes of activity per 24 hour period
Standard Deviation 40
|
PRIMARY outcome
Timeframe: 2-3 weeksSignal 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.
Outcome measures
| Measure |
Healthy Cohort
n=11 Participants
Normal healthy cohort not undergoing colorectal surgical management
|
Patients Wearing WAM Pre-op and Post-op on the Ward
n=28 Participants
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 Wore WAM Pre-op, Post-op on the Ward and Home
n=10 Participants
Patients who underwent colorectal surgery and wore a wearable activity monitor both pre-operatively, and post-operatively both on the ward and at home.
|
|---|---|---|---|
|
Time Spent in Vigorous Activity - Pre-op
|
0 minutes of activity per 24 hour period
Standard Deviation 0
|
0 minutes of activity per 24 hour period
Standard Deviation 1
|
0 minutes of activity per 24 hour period
Standard Deviation 1
|
SECONDARY outcome
Timeframe: 30 days after surgeryOutcome measures
| Measure |
Healthy Cohort
n=28 Participants
Normal healthy cohort not undergoing colorectal surgical management
|
Patients Wearing WAM Pre-op and Post-op on the Ward
n=10 Participants
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 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.
|
|---|---|---|---|
|
Number of Participants With Re-admission at Day 30
|
3 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 6 weeksOutcome measures
| Measure |
Healthy Cohort
n=28 Participants
Normal healthy cohort not undergoing colorectal surgical management
|
Patients Wearing WAM Pre-op and Post-op on the Ward
n=10 Participants
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 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.
|
|---|---|---|---|
|
Number of Participants With Complications up to 6 Weeks Post Discharge
|
10 Participants
|
4 Participants
|
—
|
Adverse Events
Healthy Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients Wearing WAM Pre-op and Post-op on the Ward
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients Who Wore WAM Pre-op, Post-op on the Ward and Home
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place