Enhancing Fitness With Preoperative Exercise in Colorectal Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
This study examines whether a home-based telephone-guided preoperative exercise programme is feasible and effective in improving cardiorespiratory fitness in patients with colorectal cancer who are high risk due to their existing co-morbidity.

Detailed Description
-----------------
Preoperative exercise, also know as prehabilitation, has been shown to improve physical fitness and potentially reduce postoperative complications in patients undergoing surgery. Patients are often labelled high risk for surgery due to their existing ill-health e.g. heart and lung disease. High risk patients comprise approximately 12% of all elective cancer cases, but account for 80% of all post-operative mortality. Complications significantly affect the quality of life of each CRC patient, both in the short and long-term, and can also impact on survival. It is critical that patients who are deemed at high risk of complications are optimised in the preoperative period. Exercise in the period before surgery is therefore one potential method of improving high risk patients' physical fitness levels while potentially reducing their risk of postoperative complications and subsequent mortality.

Official Title
-----------------
The Effect of Home-based Prehabilitation on the Cardiorespiratory Fitness of High-risk Colorectal Cancer Patients Awaiting Surgery

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Behavioral: Exercise intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary operable colorectal cancer; Awaiting surgery with curative intent; Deemed high risk by the responsible clinical team; Ability to mobilise independently Exclusion Criteria: Patients with primary or recurrent inoperable colorectal cancer. Patients undergoing preoperative chemo- and/or radiotherapy. Patients who decline or are deemed unfit for operative management. Patients who lack capacity to consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br> | Behavioral: Exercise intervention<br>* Graduated walking programme, strengthening exercises and respiratory muscle training.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiorespiratory fitness | Anaerobic threshold as measured by CPET | Preoperative period: 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in high dependency and intensive care | Critical Care bed days | Postoperative period: up to 8 weeks | 
| Readmission to critical care | Critical Care bed days | Postoperative period: up to 8 weeks (within index admission) | 
| Time to medical discharge | Medically fit for discharge | Postoperative period: up to 8 weeks. | 
| Hospital length of stay | Days | Postoperative period: within 30 days. | 
| Readmission rate |  | Within 30 days of discharge. | 
| Post-operative morbidity | Clavien-Dindo Scale | Post-operative period: at 30 days post-surgery (week 8). | 
| Health-related quality of life | SF-36 | Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8). | 
| Health-related quality of life | EORTC QLQ-C30 | Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8). | 
| Psychological health | Hospital Anxiety and Depression Score (HADS) | Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8). | 
| Frailty | Clinical Frailty Score (CSHA) | Baseline (week 0) and repeat testing (week 4). | 
| Redox blood samples | Redox status in pre- and post-exercise blood samples | Baseline (week 0) and repeat CPET (week 4). | 
| Survival | Overall and cancer-specific | 3 years post-operatively. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, colorectal, exercise, physical fitness