Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-01-01 @ 12:35 AM
Study NCT ID:
NCT02667795
Status:
COMPLETED
Last Update Posted:
2020-10-23
First Post:
2016-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Physical Fitness Prior to Colorectal Surgery: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-21', 'studyFirstSubmitDate': '2016-01-07', 'studyFirstSubmitQcDate': '2016-01-26', 'lastUpdatePostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': 'Fitness assessment'}], 'secondaryOutcomes': [{'measure': 'The EQ-5D', 'timeFrame': 'Will be done at recruitment, prior to surgery and 3 months post operatively', 'description': 'Quality of life assessment'}, {'measure': 'EORTC QLC-C30', 'timeFrame': 'Will be done at recruitment, prior to surgery and 3 months post operatively', 'description': 'Quality of life assessment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bowel Surgery']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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) .\n\nAssessments People in both groups will have an assessment on 3 occasions: when they join the study, just before surgery and 3 months after surgery.\n\nThis assessment involves:\n\nWalking 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.\n\nPeople 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older\n* Requiring elective resectional bowel surgery\n* Gives consent to participate in the study\n\nExclusion Criteria:\n\n* Younger than 18 years of age.\n* A history of unstable angina/unstable coronary artery disease or a heart attack in the previous month.\n* Any heart related disease including but not limited to aortic stenosis, pericarditis or any thromboembolic disease.\n* Severe Infections and fever.\n* Uncontrolled metabolic diseases.\n* Resting heart rate of more than 120 BPM.\n* Systolic blood pressure of more than 180 mm Hg or diastolic blood pressure of more than 110 mm Hg.\n* Recent cerebrovascular accident.\n* Pregnancy\n* Pre-existing severe physical disability.\n* Unwilling to allow their GP to be informed of their participation in the study.\n* Not able or unwilling to consent to take part in the study'}, 'identificationModule': {'nctId': 'NCT02667795', 'briefTitle': 'Improving Physical Fitness Prior to Colorectal Surgery: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'York Teaching Hospitals NHS Foundation Trust'}, 'officialTitle': 'Improving Physical Fitness Prior to Colorectal Surgery: A Pilot Study', 'orgStudyIdInfo': {'id': 'SNE 2447'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Monitored walking based exercise', 'description': '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.', 'interventionNames': ['Other: Monitored walking based exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention'}], 'interventions': [{'name': 'Monitored walking based exercise', 'type': 'OTHER', 'description': 'Monitored walking based exercise', 'armGroupLabels': ['Monitored walking based exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Scarborough', 'state': 'Yorkshire', 'country': 'United Kingdom', 'facility': 'Scarborough General Hospital', 'geoPoint': {'lat': 54.27966, 'lon': -0.40443}}], 'overallOfficials': [{'name': 'John Macfie, MBChB, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'York Teaching Hospitals NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'York Teaching Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}