Improving Physical Fitness Prior to Colorectal Surgery: A Pilot Study
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|ClinicalTrials.gov Identifier: NCT02667795|
Recruitment Status : Recruiting
First Posted : January 29, 2016
Last Update Posted : February 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bowel Surgery||Other: Monitored walking based exercise||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Improving Physical Fitness Prior to Colorectal Surgery: A Pilot Study|
|Study Start Date :||October 2016|
|Actual Primary Completion Date :||November 21, 2018|
Experimental: Monitored walking based exercise
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.
Other: Monitored walking based exercise
Monitored walking based exercise
No Intervention: Control
- 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
- The EQ-5D [ Time Frame: Will be done at recruitment, prior to surgery and 3 months post operatively ]Quality of life assessment
- EORTC QLC-C30 [ Time Frame: Will be done at recruitment, prior to surgery and 3 months post operatively ]Quality of life assessment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02667795
|Contact: John M Trotter, MBChBfirstname.lastname@example.org|
|Scarborough General Hospital||Recruiting|
|Scarborough, Yorkshire, United Kingdom|
|Contact: John Trotter email@example.com|
|Study Director:||John Macfie, MBChB, MD||York Teaching Hospitals NHS Foundation Trust|