Supervised Exercise for Post-surgery Colorectal Cancer Patients

Summary

Participants will undergo preoperative baseline screening and will be randomised to either normal postoperative care or a 12-week supervised exercise programme comprising of both an aerobic and resistance component

They will be assessed prior to surgery which will include cardiopulmonary exercise testing (CPET). This is a well-established method of assessing aerobic exercise response and is widely used in the perioperative period for assessment of cancer patients with co-morbidity. The assessment days will also include:

* muscle ultrasound (vastus lateralis) to ascertain muscle structure (thickness, pennation angle and fascicle length),
* blood tests,
* functional composite scores,
* quality of life questionnaires,

The assessment days will be carried out at four time points during the study; prior to surgery, before commencement of the exercise program, halfway through the intervention (6 weeks post commencement of exercise) and at the end of the study. In the week before the assessment days patients will wear a physical activity monitor to characterise their daily movements. The control group will also be assessed at the same time points and wear the activity monitors but will not take part in the exercise program.

All participants will have a physical activity monitor placed onto the right thigh in the midline at postoperative day 1 until discharge or day 7, whichever is sooner. This is a non-invasive measure of activity and can discriminate between whether a patient is lying, sitting, standing or walking.

Once participants self-report feeling able to start exercising again post-discharge, they will commence the 12 week programme. The intervention will consist of 2 resistance training (RET) sessions per week and 75 minutes of vigorous or 150 minutes of moderate aerobic exercise per week (can be split according to patient preference). They will receive a diary to log their sessions and will be monitored via twice weekly virtual follow-up (either telephone or video calling) and for the first 6 weeks weekly visits to ensure that they are adherent to the exercise protocol and provide any support/advice. Satisfactory compliance with the programme will be considered to be the completion of at least 27 sessions over the 12 week period, with a minimum of 13 out of 18 and 14 out of 18 sessions completed in the first and last 6 weeks, respectively.

Conditions

• Colorectal Cancer
• Colorectal Neoplasms

Interventions

BEHAVIORAL

Aerobic and resistance training 12 week exercise programme

See arm/group description

DIAGNOSTIC_TEST

Venous blood sampling

full blood count, urea \& electrolytes, C-reactive protein, coagulation screen, liver function tests, erythrocyte sedimentation rate.

DIAGNOSTIC_TEST

Muscle Ultrasound

Ultrasound of vastus lateralis to ascertain muscle structure (thickness, pennation angle and fascicle length)

DIAGNOSTIC_TEST

Cardiopulmonary exercise testing (CPET)

The assessment of anaerobic threshold as a measure of changes in aerobic function between the two groups will be assessed using CPET

BEHAVIORAL

Quality of life questionnaire completion

The use of validated questionnaires to assess quality of life parameters; Duke Activity Status Index (DASI), EORTC-QLQ C30 (quality of life for cancer patients) and the International Physical Activity Questionnaire (IPAQ).

Sponsors & Collaborators

• University Hospitals of Derby and Burton NHS Foundation Trust

  collaborator OTHER

• University of Nottingham

  lead OTHER

Principal Investigators

• Jon Lund, MD, FRCS · [email protected]

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-13

Primary Completion

2024-01-27

Completion

2024-01-27

Countries

• United Kingdom

Study Locations