The Effect of Home-based Prehabilitation on the Cardiorespiratory Fitness of High-risk Colorectal Cancer Patients Awaiting Surgery
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 72
- Locations
- 8
- Primary Endpoint
- Change in cardiorespiratory fitness
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control
Intervention
Intervention: Exercise intervention (Behavioral)
Outcomes
Primary Outcomes
Change in cardiorespiratory fitness
Time Frame: Preoperative period: 4 weeks
Anaerobic threshold as measured by CPET
Secondary Outcomes
- Hospital length of stay(Postoperative period: within 30 days.)
- Survival(3 years post-operatively.)
- Readmission rate(Within 30 days of discharge.)
- Post-operative morbidity(Post-operative period: at 30 days post-surgery (week 8).)
- Psychological health(Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).)
- Frailty(Baseline (week 0) and repeat testing (week 4).)
- Length of stay in high dependency and intensive care(Postoperative period: up to 8 weeks)
- Readmission to critical care(Postoperative period: up to 8 weeks (within index admission))
- Time to medical discharge(Postoperative period: up to 8 weeks.)
- Redox blood samples(Baseline (week 0) and repeat CPET (week 4).)
- Health-related quality of life(Baseline (week 0), post-intervention (week 4), at 30 days postoperatively (week 8).)