Supportive exercise programmes for accelerating recovery after major abdominal cancer surgery

Not Applicable

• Conditions: Malignant neoplasms of digestive organs; Colorectal cancer; Cancer

• Registration Number: ISRCTN82233115
• Lead Sponsor: orfolk and Norwich University Hospitals NHS Foundation Trust

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34245094 (added 01/11/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-07
• Last Update Posted: 19 December 2023
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1146

Inclusion Criteria

1. Male and female participants = 18 years old
2. Awaiting a curative elective colorectal resection for cancer
3. American Society of Anaesthesiologists physical status I-III (ASA, 2014)
4. Able and willing to provide informed consent
5. Understand verbal and written instructions in English
6. Patients who are already participating (or have participated) in other trials may be eligible, but this must be agreed in advance by the relevant trial teams

Exclusion Criteria

1. Contra-indications to exercise (e.g. lower limb amputation without prosthesis, orthopaedic disorder exacerbated by exercise, chronic lung disease causing desaturation with exercise or shortness of breath at rest, severe psychiatric health problems)
2. Cardiovascular contraindications (e.g. unstable angina, acute left ventricular failure, uncontrolled cardiac arrhythmias, uncontrolled hypertension, cardiac event in the previous 6 weeks, cerebral vascular disease resulting in transient ischaemic attacks)
3. Participation in other treatment trials, where this has not been agreed in advance with both trial teams

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health-related quality of life is measured using the Study Short-Form Health Questionnaire (SF-36) at baseline and 12 months post-randomisation.

Secondary Outcome Measures

Name	Time	Method
1. Post-operative morbidity is measured 30 days post-surgery<br>2. Cardiopulmonary fitness <br>3. Grip strength<br>4. Length of hospital stay is recorded at discharge following operation<br>5. Fitness for discharge is recorded at discharge following operation<br>6. Re-admission rate is determined 90 days post-surgery<br>7. Post-operative mortality is measured 90 days post-surgery<br>8. Physical activity behaviour is measured 6 and 12 months<br>9. Psychological health status is measured 6 and 12 months