Clinical trial NCT02667795: Improving Physical Fitness Prior to Colorectal Surgery: A Pilot Study
Official title: Improving Physical Fitness Prior to Colorectal Surgery: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Surgery
Lead sponsor: York Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Requiring elective resectional bowel surgery
* Gives consent to participate in the study

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
measure: Change in fitness as assessed by Six Minute Walk Test
timeFrame: Will be done at recruitment, prior to surgery and 3 months post operatively
Secondary outcomes:
measure: The EQ-5D
timeFrame: Will be done at recruitment, prior to surgery and 3 months post operatively
measure: EORTC QLC-C30
timeFrame: Will be done at recruitment, prior to surgery and 3 months post operatively
Other outcomes:
Locations:
city: Scarborough
country: United Kingdom
facility: Scarborough General Hospital
state: Yorkshire
Study officials:
affiliation: York Teaching Hospitals NHS Foundation Trust
name: John Macfie, MBChB, MD
role: STUDY_DIRECTOR
References: