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

Not Applicable

Completed

• Conditions: Preoperative Care; Colorectal Neoplasms; Exercise; Aged
• Interventions: Behavioral: HIT

• Registration Number: NCT02188342
• Lead Sponsor: University of Nottingham

Brief Summary

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.

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 Timeline

• Study First Submitted: 2014-07-10
• Study First Submitted QC: 2014-07-10
• Study First Posted: 2014-07-11
• Study Start: 2015-01
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-26
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HIT exercise training	HIT	-

Primary Outcome Measures

Name	Time	Method
VO2 peak	After 31 days of HIT	Mean difference in VO2 peak following a HIT programme

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Nottingham; 🇬🇧 Derby, Derbyshire, United Kingdom