Improving Physical Fitness Prior to Colorectal Surgery: A Pilot Study
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Yorkshire
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Scarborough, Yorkshire, Verenigd Koninkrijk
- Scarborough General Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Geen tussenkomst: Controle
Geen tussenkomst
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Experimenteel: 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.
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Monitored walking based exercise
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in fitness as assessed by Six Minute Walk Test
Tijdsspanne: Will be done at recruitment, prior to surgery and 3 months post operatively
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Fitness assessment
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Will be done at recruitment, prior to surgery and 3 months post operatively
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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The EQ-5D
Tijdsspanne: Will be done at recruitment, prior to surgery and 3 months post operatively
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Quality of life assessment
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Will be done at recruitment, prior to surgery and 3 months post operatively
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EORTC QLC-C30
Tijdsspanne: Will be done at recruitment, prior to surgery and 3 months post operatively
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Quality of life assessment
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Will be done at recruitment, prior to surgery and 3 months post operatively
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Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: John Macfie, MBChB, MD, York Teaching Hospitals NHS Foundation Trust
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- SNE 2447
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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