Improving Physical Fitness Prior to Colorectal Surgery: A... | NCT02667795

Studies
Improving Physical Fitness Prior to Colorectal Surgery: A Pilot Study

NCT02667795

Sponsor

York Teaching Hospitals NHS Foundation Trust

Status

Completed

Last Update Posted

Oct 23, 2020Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Bowel Surgery

Interventions

Monitored walking based exercise

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Nov 21, 2018Actual

Completion Date

Nov 21, 2019Actual

First Submitted Date

Jan 7, 2016

First Submission Date that Met QC Criteria

Jan 26, 2016

First Posted Date

Jan 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2020

Last Update Posted Date

Oct 23, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Monitored walking based exercise	Experimental	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
Control	No Intervention	No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Monitored walking based exercise	Other	Monitored walking based exercise	Monitored walking based exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in fitness as assessed by Six Minute Walk Test	Fitness assessment	Will be done at recruitment, prior to surgery and 3 months post operatively

Secondary Outcomes

Measure	Description	Time Frame
The EQ-5D	Quality of life assessment	Will be done at recruitment, prior to surgery and 3 months post operatively
EORTC QLC-C30	Quality of life assessment

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Macfie, MBChB, MD	York Teaching Hospitals NHS Foundation Trust	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Scarborough General Hospital		Scarborough	Yorkshire		United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided