Bowel SurgeryNCT02667795
Improving Physical Fitness Prior to Colorectal Surgery: A Pilot Study
A study testing Monitored walking based exercise in people with Bowel Surgery, run by York Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
It is generally accepted that physically fit patients cope much better with the stress of surgery and recover faster. Consequently several research studies have tried to increase people's level of fitness before they have surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Surgery
- What is being tested?
- Monitored walking based exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2016to 21 Nov 2019
- Phase
- Interventional
- 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
Who may be able to join
- Aged 18 years or older
- Requiring elective resectional bowel surgery
- Gives consent to participate in the study
Who cannot join
- Younger than 18 years of age.
- A history of unstable angina/unstable coronary artery disease or a heart attack in the previous month.
- Any heart related disease including but not limited to aortic stenosis, pericarditis or any thromboembolic disease.
- Severe Infections and fever.
- Uncontrolled metabolic diseases.
- Resting heart rate of more than 120 BPM.
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- Systolic blood pressure of more than 180 mm Hg or diastolic blood pressure of more than 110 mm Hg.
- Recent cerebrovascular accident.
- Pregnancy
- Pre-existing severe physical disability.
- Unwilling to allow their GP to be informed of their participation in the study.
- Not able or unwilling to consent to take part in the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Scarborough General Hospital
Scarborough, Yorkshire
About this study
It is generally accepted that physically fit patients cope much better with the stress of surgery and recover faster. Consequently several research studies have tried to increase people's level of fitness before they have surgery. These previous research studies have usually required patients to carry out intense, structured exercise programmes that involve going to a gym. However such programmes are not 'user friendly' especially if people are not used to taking a lot of exercise. In this pilot study we want to test the feasibility of a home based programme that tries to increase patients' level of fitness by gradually increasing the number of steps they walk every day.
Read the detailed description
Participants will be randomised into one of two groups. One group of participants will be asked to increase their level of activity by gradually walking further (the exercise group) and the other group will carry on with their usual level of activity (the usual activity group) .
Assessments People in both groups will have an assessment on 3 occasions: when they join the study, just before surgery and 3 months after surgery.
This assessment involves:
Walking for 6 minutes up and down a corridor to see how far they can walk. Asking them for some information about their medical history Completing three questionnaires about how they are feeling and their quality of life.
People who are randomised to the exercise group will be advised about how many steps to take based on how they did in the initial walking assessment. The number of days or weeks they will be asked to take a daily walk will depend on how much time there is between them joining the study and the date of their surgery. We think this will be about 2 weeks.
- Conditions
- Bowel Surgery
- Being tested
- Monitored walking based exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitored walking based exerciseOther
Monitored walking based exercise
| Study group | Role | What they receive |
|---|---|---|
| Monitored walking based exercise | Experimental | Participants will be given a personalised daily exercise target. Participants will be given an activity tracker (a Fitbit ZipTM). The participants will be asked to wear the device all day to monitor their activity. Once a day the participants will be asked to complete the walking target they have been given at completion of their baseline assessment. This target should be completed in one go. The walking programme will last a minimum of 2 weeks and a maximum duration of 4 weeks. The length of time will depend on the length of time between recruitment and when the participant is scheduled to have their surgery. Receives: Other: Monitored walking based exercise |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fitness as assessed by Six Minute Walk Test
Fitness assessment
Measured: Will be done at recruitment, prior to surgery and 3 months post operatively
Secondary outcomes (2)
The EQ-5D
Quality of life assessment
Measured: Will be done at recruitment, prior to surgery and 3 months post operatively
EORTC QLC-C30
Quality of life assessment
Measured: Will be done at recruitment, prior to surgery and 3 months post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startOct 2016
- Primary completion21 Nov 2018
- Study completion21 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel SurgeryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- York Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Macfie, MBChB, MD, Study director, York Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667795
- Sponsor's protocol ID
- SNE 2447
- Status last verified
- Oct 2020
- First submitted
- 7 Jan 2016
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Physical Fitness Prior to Colorectal Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT02667795
- Acronym / sponsor ID
- SNE 2447
- Conditions
- Bowel Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- York Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 21 Nov 2019 (actual)
- First posted
- 29 Jan 2016 (estimated)
- 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.
It is generally accepted that physically fit patients cope much better with the stress of surgery and recover faster. Consequently several research studies have tried to increase people's level of fitness before they have surgery. These previous research studies have usually required patients to carry out intense, structured exercise programmes that involve going to a gym. However such programmes are not 'user friendly' especially if people are not used to taking a lot of exercise. In this pilot study we want to test the feasibility of a home based programme that tries to increase patients' level of fitness by gradually increasing the number of steps they walk every day.
Detailed description
Participants will be randomised into one of two groups. One group of participants will be asked to increase their level of activity by gradually walking further (the exercise group) and the other group will carry on with their usual level of activity (the usual activity group) .
Assessments People in both groups will have an assessment on 3 occasions: when they join the study, just before surgery and 3 months after surgery.
This assessment involves:
Walking for 6 minutes up and down a corridor to see how far they can walk. Asking them for some information about their medical history Completing three questionnaires about how they are feeling and their quality of life.
People who are randomised to the exercise group will be advised about how many steps to take based on how they did in the initial walking assessment. The number of days or weeks they will be asked to take a daily walk will depend on how much time there is between them joining the study and the date of their surgery. We think this will be about 2 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitored walking based exercise | Experimental | Other: Monitored walking based exerciseParticipants will be given a personalised daily exercise target. Participants will be given an activity tracker (a Fitbit ZipTM). The participants will be asked to wear the device all day to monitor their activity. Once a day the participants will be asked to complete the walking target they have been given at completion of their baseline assessment. This target should be completed in one go. The walking programme will last a minimum of 2 weeks and a maximum duration of 4 weeks. The length of time will depend on the length of time between recruitment and when the participant is scheduled to have their surgery. |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or older
- Requiring elective resectional bowel surgery
- Gives consent to participate in the study
Key exclusion criteria (12 listed)
- Younger than 18 years of age.
- A history of unstable angina/unstable coronary artery disease or a heart attack in the previous month.
- Any heart related disease including but not limited to aortic stenosis, pericarditis or any thromboembolic disease.
- Severe Infections and fever.
- Uncontrolled metabolic diseases.
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 |
|---|---|---|
| Monitored walking based exerciseMonitored walking based exercise | Other | Monitored walking based exercise |
Primary outcome
Change in fitness as assessed by Six Minute Walk Test
Time frame: Will be done at recruitment, prior to surgery and 3 months post operatively
Fitness assessment
2 secondary outcomes
The EQ-5D
Time frame: Will be done at recruitment, prior to surgery and 3 months post operatively
EORTC QLC-C30
Time frame: Will be done at recruitment, prior to surgery and 3 months post operatively
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 23 Oct 2020.
- 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.
John Macfie, MBChB, MD study director
York Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitored walking based exercise in people with Bowel Surgery, run by York Teaching Hospitals NHS Foundation Trust 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 12 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 23 Oct 2020. 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?
Change in fitness as assessed by Six Minute Walk Test (time frame: Will be done at recruitment, prior to surgery and 3 months post operatively). 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 23 Oct 2020.