Assessing The Effectiveness of a Preoperative High Intensity Interval Training Programme In Older Colorectal Cancer Patients (HITCa)

July 26, 2017 updated by: University of Nottingham

Effectiveness of Short Term, High Intensity, Interval Exercise Training in Older Colorectal Cancer Patients in Improving Preoperative Fitness

The primary aim of this study is to determine whether an improvement in aerobic fitness, as judged by an increase in VO2peak, can be achieved within 31 days via HIT programme in a group of older, colorectal cancer patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

12 high intensity interval training exercise sessions on a static cycle ergometer, over a period of 31 days. Each session lasts 18 minutes.

At the beginning and end of the study the following measures will be used to assess change in fitness, body composition and muscle metabolism. DXA scan, USS of thigh, VO2 peak cycling test, short performance battery tests, quality of life questionnaires and muscle biopsy.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Derbyshire
      • Derby, Derbyshire, United Kingdom, DE22 3DT
        • University of Nottingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed colorectal cancer
  • Offered curative treatment by the Royal Derby Hospital NHS Foundation Trust Colorectal Cancer Multidisciplinary Team
  • Male and female
  • 18-88 years of age

Exclusion Criteria:

  • Uncontrolled hypertension (BP > 160/100),
  • Angina,
  • Heart failure (class III/IV),
  • Cardiac arrthymias,
  • Right to left cardiac shunt,
  • Recent cardiac event,
  • Previous stroke/TIA,
  • Aneurysm (large vessel or intracranial),
  • Severe respiratory disease including pulmonary hypertension,
  • COPD/asthma with an FEV1 less than 1.5 l,
  • Coagulation disorders,
  • Scarring disorders.
  • Current neoadjuvant chemo/radiotherapy
  • Inability to complete the consent process Involvement in invasive research study in previous 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HIT exercise training
Behavioral: HIT
12 HIT exercise sessions in 31 days on a stationary cycle ergometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VO2 peak
Time Frame: After 31 days of HIT
Mean difference in VO2 peak following a HIT programme
After 31 days of HIT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anaerobic threshold
Time Frame: After 31 days of HIT
Mean difference in anaerobic threshold following a HIT programme
After 31 days of HIT
Muscle protein synthesis
Time Frame: After 31 days of HIT
Assessment of D2O evaluated muscle protein synthesis following HIT programme
After 31 days of HIT
Body composition
Time Frame: After 31 days of HIT
DXA and USS assessed changes in lean muscle mass and architecture following a HIT programme
After 31 days of HIT
Feasibility
Time Frame: After 31 days of HIT
Determination of patient compliance and adherence to HIT programme
After 31 days of HIT
Quality of life
Time Frame: After 31 days of HIT
Quality of life and performance questionnaires to measure subjective outcomes (EQ-5D, IPAQ, DASI, WEMWBS)
After 31 days of HIT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Collaborators

University Hospitals of Derby and Burton NHS Foundation Trust

Investigators

  • Principal Investigator: John Williams, BSc MBChB FRCA PhD, University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

July 10, 2014

First Submitted That Met QC Criteria

July 10, 2014

First Posted (Estimate)

July 11, 2014

Study Record Updates

Last Update Posted (Actual)

July 31, 2017

Last Update Submitted That Met QC Criteria

July 26, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HITCa

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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