An Observational Cohort Study to Assess the Postop Activity of Colorectal Patients Undergoing Elective Surgery (PHYSPAL) (PHYSPAL)

An Observational Cohort Study to Assess the Postoperative Physical Activity of Patients Undergoing Elective Colorectal Resection.

All participants will have a physical activity monitor placed onto the right thigh in the midline which will start collecting data at midnight on the first postoperative day. This will continue until discharge or day 7, whichever is earlier. This is a non-invasive measure of activity and can discriminate between whether a patient is lying, sitting, standing or walking. There is no control group.

Study Overview

• Status: Completed
• Conditions: Colorectal (Colon or Rectal) Cancer
• Intervention / Treatment: Device: ActivPAL accelerometer; Other: Hospital Anxiety and Depression Scale (HADS) Questionnaire

Detailed Description

Recruited patients from the colorectal clinic at the Royal Derby Hospital will be invited to be included in the study, and can either attend the University of Nottingham, Centre Of Metabolism, Ageing & Physiology (COMAP) research group unit at the Royal Derby Hospital Centre or discuss the trial in detail over the phone after which a consent form will be sent to them (either by post or email). If they agree to inclusion in the study the consent form will be brought with them to be completed on the day of surgery. On the morning of surgery they will have their consent recorded and the activPAL™ accelerometer applied to the anterior thigh.

The activPAL™ is a non-invasive physical monitor that records periods spent, lying, walking and engaging in more strenuous activity. This will remain in situ for 7 days, or until discharge, whichever comes first. The investigators will ask participants to complete a short diary to note down any times the monitor is removed and the time of sleep and waking. After removal - the data is uploaded (it does not include any person-identifiable data) for analysis using software on a local computer in the COMAP unit. After discharge, they will have 2 x telephone calls and/or emails at day 10 and at day 28 to follow up from the research team to monitor progress for the next 30 days. If they develop any complications including readmission data within that time period, this will be collected from the participants' notes along with demographic data and postoperative pathology and recorded. Complications will be graded as per the Clavien-Dindo Classification system.

On postoperative day 3, day 5 and day 7 (if still an inpatient) they will also be asked to complete the Hospital Anxiety and Depression Scale (HADS) paper questionnaire. Just prior to discharge, they will complete the discharge questionnaire.

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• United Kingdom
  • Derby, United Kingdom, DE22 3DT
    • University of Nottingham, Royal Derby Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients presenting to Royal Derby Hospital who have gone through colorectal multidisciplinary team (MDT) meeting with a plan for surgical resection of colorectal cancer with curative intent.

Description

Inclusion Criteria:

• Aged 18 years and over
• Clinical diagnosis of colorectal cancer due to undergo surgical resection with curative intent
• Must be able to give informed consent

Exclusion Criteria:

• Lacking capacity to consent
• Undergoing emergency surgery
• Undergoing defunctioning surgery prior to neoadjuvant treatment
• Undergoing surgery with palliative intent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average daily energy expenditure in MET.h	Using the ActivPAL accelerometers, to assess the MET.h per each postoperative day	30 days from operation date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step count	Using the ActivPAL accelerometers, record average daily step count	From the first postoperative day until discharge or day 7, whichever is sooner.
Sit to stands	Using the ActivPAL accelerometers, record average daily sit-to-stand count	From the first postoperative day until discharge or day 7, whichever is sooner.
Time spent in bed	Using the ActivPAL accelerometers, record average time spent in bed in hours.	From the first postoperative day until discharge or day 7, whichever is sooner.
30-day complication rate	All postoperative complications will be recorded and classified as per the Clavien-Dindo classification.	30 days from operation date.

Collaborators and Investigators

• Sponsor: University of Nottingham
• Investigators: Principal Investigator: Jon Lund, DM, FRCS, University of Nottingham

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): April 24, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: June 28, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 23025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No