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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
Sponsor:
Information provided by (Responsible Party):
York Teaching Hospitals NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Bowel Surgery Other: Monitored walking based exercise Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
No intervention



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. The EQ-5D [ Time Frame: Will be done at recruitment, prior to surgery and 3 months post operatively ]
    Quality of life assessment

  2. EORTC QLC-C30 [ Time Frame: Will be done at recruitment, prior to surgery and 3 months post operatively ]
    Quality of life assessment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: John M Trotter, MBChB 00447743826389 j.trotter@nhs.net

Locations
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United Kingdom
Scarborough General Hospital Recruiting
Scarborough, Yorkshire, United Kingdom
Contact: John Trotter       john.trotter@york.nhs.uk   
Sponsors and Collaborators
York Teaching Hospitals NHS Foundation Trust
Investigators
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Study Director: John Macfie, MBChB, MD York Teaching Hospitals NHS Foundation Trust

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Responsible Party: York Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02667795     History of Changes
Other Study ID Numbers: SNE 2447
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No