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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Preoperative Care, Colorectal Neoplasms, Aged, Exercise

Intervention / Treatment
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* Behavioral: HIT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 88 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIT exercise training<br> | Behavioral: HIT<br>* 12 HIT exercise sessions in 31 days on a stationary cycle ergometer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2 peak | 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 | Mean difference in anaerobic threshold following a HIT programme | After 31 days of HIT | 
| Muscle protein synthesis | Assessment of D2O evaluated muscle protein synthesis following HIT programme | After 31 days of HIT | 
| Body composition | DXA and USS assessed changes in lean muscle mass and architecture following a HIT programme | After 31 days of HIT | 
| Feasibility | Determination of patient compliance and adherence to HIT programme | After 31 days of HIT | 
| Quality of life | Quality of life and performance questionnaires to measure subjective outcomes (EQ-5D, IPAQ, DASI, WEMWBS) | After 31 days of HIT |