Improving Physical Fitness Prior to Colorectal Surgery: A Pilot Study

Bowel Surgery Clinical Trial

Official title:

Improving Physical Fitness Prior to Colorectal Surgery: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02667795
• Other study ID #: SNE 2447
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: November 21, 2019

Study information

• Verified date: October 2020
• Source: York Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 21, 2019
• Est. primary completion date: November 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bowel Surgery

Intervention

Other:
• Monitored walking based exercise
Monitored walking based exercise

Locations

Country	Name	City	State
United Kingdom	Scarborough General Hospital	Scarborough	Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
York Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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