Effect of pre-operative exercise on cardiovascular fitness in patients undergoing surgery for major upper gastro-intestinal cancer.

Not Applicable

• Conditions: Cancer involving the upper gastrointestinal tract, including oesophagus, stomach, duodenum, pancreas, liver and bile duct.; Surgery - Other surgery; Anaesthesiology - Anaesthetics; Cancer - Oesophageal (gullet)

• Registration Number: ACTRN12617000265370
• Lead Sponsor: Hunter New England Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-21
• Study Completion: 2018-06-29
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

All patients undergoing major upper gastrointestinal (GI) cancer surgery at John Hunter and Newcastle Private Hospitals

Exclusion Criteria

- Unresectable/ metastatic disease at any point within the study
- Known Class III/IV heart failure or moderate to severe pulmonary hypertension
- Poorly controlled cardiac arrhythmia/ excluded by an anaesthetist or a cardiologist
- Uncontrolled hypertension >180/100
- Angina
- Claudication
- Vascular Aneurysm
- Severe COPD with FEV1<50% predicted
- For safety reasons, we cannot enrol people who don’t speak basic English in a
maximal intensity exercise program as we cannot provide a safe environment
without a trained, NSW Health registered translator for every exercise session.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in mean anaerobic threshold as determined by;<br>- Proportion of participants achieving an increase of at least 1.8mL/kg/min as determined by serial cardiopulmonary exercise testing prior and following participation in exercise program.<br><br>CPET testing will be performed on a calibrated electronically-braked cycle ergometer. The rate at which power will increase each minute will be individualised, with the aim of achieving a test duration of between 8 and 12 minutes. Breath-by-breath expired gas analysis will be undertaken using a Medisoft Exp'air metabolic cart. Peak exercise capacity will be defined as the rate of oxygen consumption averaged over the final 20 second epoch of the CPET. Lactate threshold will be determined using the ‘combined method[time point of initial CPET is following the first clinic visit to book surgery and the final CPET is in the week prior to surgery]

Secondary Outcome Measures

Name	Time	Method
Major surgical complication as defined by Clavien-Dindo IIIb or greater[90 days postoperatively];Change in serum C1q prior to and following exercise program[initial test following clinic visit where surgery is booked<br>final test in the week prior to surgery];Sarcopaenia as determined by CT Scan at time of diagnosis and 3 months following surgery[Initial scan around the time of initial clinic visit and subsequent CT scan 3 months following surgery];Physiotherapist supervised 6 minute walk test result[measured during initial and final exercise session];Mortality[90 days post-operatively];Days spent in ICU (mean)[Days spent in ICU post-operatively prior to discharge.];Length of stay (mean)[length of stay post-operatively];Post-operative pulmonary complication as defined by the Melbourne Group Scale[30 days post-operatively]