Colorectal (Colon or Rectal) CancerPHYSPALNCT05934643
An Observational Cohort Study to Assess the Postop Activity of Colorectal Patients Undergoing Elective Surgery (PHYSPAL)
An observational study of Colorectal (Colon or Rectal) Cancer, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal (Colon or Rectal) Cancer
- What is being tested?
- ActivPAL accelerometer and Hospital Anxiety and Depression Scale (HADS) Questionnaire
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2023to 30 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Lacking capacity to consent
- Undergoing emergency surgery
- Undergoing defunctioning surgery prior to neoadjuvant treatment
- Undergoing surgery with palliative intent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham, Royal Derby Hospital
Derby, DE22 3DT
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal (Colon or Rectal) Cancer
- Being tested
- ActivPAL accelerometer, Hospital Anxiety and Depression Scale (HADS) Questionnaire
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActivPAL accelerometerDevice
All patient will have an accelerometer (activPAL) applied to characterise the type and quantity of movement during the inpatient postoperative period after undergoing major surgery for colorectal cancer surgery.
Hospital Anxiety and Depression Scale (HADS) QuestionnaireOther
The use of the HADS questionnaire to ascertain if any correlation between level of activity and and inpatient mood.
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily energy expenditure in MET.h
Using the ActivPAL accelerometers, to assess the MET.h per each postoperative day
Measured: 30 days from operation date
Secondary outcomes (4)
Step count
Using the ActivPAL accelerometers, record average daily step count
Measured: 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
Measured: 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.
Measured: 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.
Measured: 30 days from operation date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start1 Sep 2023
- Primary completion24 Apr 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal (Colon or Rectal) CancerStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon Lund, DM, FRCS, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934643
- Sponsor's protocol ID
- 23025
- Acronym
- PHYSPAL
- Status last verified
- Apr 2025
- First submitted
- 9 Jun 2023
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cohort Study to Assess the Postoperative Physical Activity of Patients Undergoing Elective Colorectal Resection.
- ClinicalTrials.gov ID
- NCT05934643
- Acronym / sponsor ID
- PHYSPAL / 23025
- Conditions
- Colorectal (Colon or Rectal) Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Lacking capacity to consent
- Undergoing emergency surgery
- Undergoing defunctioning surgery prior to neoadjuvant treatment
- Undergoing surgery with palliative intent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActivPAL accelerometerAll patient will have an accelerometer (activPAL) applied to characterise the type and quantity of movement during the inpatient postoperative period after undergoing major surgery for colorectal cancer surgery. | Device | – |
| Hospital Anxiety and Depression Scale (HADS) QuestionnaireThe use of the HADS questionnaire to ascertain if any correlation between level of activity and and inpatient mood. | Other | – |
Primary outcome
Average daily energy expenditure in MET.h
Time frame: 30 days from operation date
Using the ActivPAL accelerometers, to assess the MET.h per each postoperative day
4 secondary outcomes
Step count
Time frame: From the first postoperative day until discharge or day 7, whichever is sooner.
Sit to stands
Time frame: From the first postoperative day until discharge or day 7, whichever is sooner.
Time spent in bed
Time frame: From the first postoperative day until discharge or day 7, whichever is sooner.
30-day complication rate
Time frame: 30 days from operation date.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Lund, DM, FRCS principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal (Colon or Rectal) Cancer, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average daily energy expenditure in MET.h (time frame: 30 days from operation date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.