Improving Physical Fitness Prior to Colorectal Surgery: A Pilot Study

NCT02667795 | Completed

• 1 other identifier: SNE 2447
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Surgery

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• The EQ-5D

  Will be done at recruitment, prior to surgery and 3 months post operatively

• EORTC QLC-C30

  Will be done at recruitment, prior to surgery and 3 months post operatively

Study Arms (2)

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

Monitored walking based exercise OTHER

Monitored walking based exercise

Monitored walking based exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older
• Requiring elective resectional bowel surgery
• Gives consent to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• York Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Scarborough General Hospital

Scarborough, Yorkshire, United Kingdom

Location

Study Officials

• John Macfie, MBChB, MD

  York Teaching Hospitals NHS Foundation Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 29, 2016
• Study Start: October 1, 2016
• Primary Completion: November 21, 2018
• Study Completion: November 21, 2019
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)