Colorectal Cancer Clinical Trial
— EFExOfficial title:
The Effect of Home-based Prehabilitation on the Cardiorespiratory Fitness of High-risk Colorectal Cancer Patients Awaiting Surgery
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.
Status | Not yet recruiting |
Enrollment | 72 |
Est. completion date | October 2020 |
Est. primary completion date | April 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Hairmyres Hospital | East Kilbride | |
United Kingdom | Queen Elizabeth University Hospital | Glasgow | |
United Kingdom | University Hospital Crosshouse | Kilmarnock | |
United Kingdom | Royal Alexandra Hospital | Paisley |
Lead Sponsor | Collaborator |
---|---|
NHS Greater Glasgow and Clyde | National Heatlh Service Ayrshire and Arran, NHS Lanarkshire, University of Southampton |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Feasibility of home-based exercise | Recruitment, retention, adherence rates | Preoperative period: 4 weeks. | |
Primary | Change in cardiorespiratory fitness | Anaerobic threshold as measured by CPET | Preoperative period: 4 weeks | |
Secondary | Length of stay in high dependency and intensive care | Critical Care bed days | Postoperative period: up to 8 weeks | |
Secondary | Readmission to critical care | Critical Care bed days | Postoperative period: up to 8 weeks (within index admission) | |
Secondary | Time to medical discharge | Medically fit for discharge | Postoperative period: up to 8 weeks. | |
Secondary | Hospital length of stay | Days | Postoperative period: within 30 days. | |
Secondary | Readmission rate | Within 30 days of discharge. | ||
Secondary | Post-operative morbidity | Clavien-Dindo Scale | Post-operative period: at 30 days post-surgery (week 8). | |
Secondary | Health-related quality of life | SF-36 | Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8). | |
Secondary | Health-related quality of life | EORTC QLQ-C30 | Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8). | |
Secondary | Psychological health | Hospital Anxiety and Depression Score (HADS) | Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8). | |
Secondary | Frailty | Clinical Frailty Score (CSHA) | Baseline (week 0) and repeat testing (week 4). | |
Secondary | Redox blood samples | Redox status in pre- and post-exercise blood samples | Baseline (week 0) and repeat CPET (week 4). | |
Secondary | Survival | Overall and cancer-specific | 3 years post-operatively. |
Status | Clinical Trial | Phase | |
---|---|---|---|
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