The purpose of this feasibility study is to determine whether a structured exercise programme prior to oesophagectomy has: acceptable adherence, is safe, and improves physiological measures of physical fitness above standard care.
The number of patients with oesophageal cancer is rising dramatically in the UK. Curative cancer surgery (oesophagectomy) is offered to around 40% of affected patients. However, oesophagectomy is a major operation with a high risk of complications. Around 1 in 3 patients will suffer such a complication after surgery, mostly due to heart or lung problems. Most complications are not due to the surgery itself, but related to the patient's physical fitness before their operation. Studies in other surgeries, but not oesophagectomy, have shown that complications may be reduced by improving a patient's physical fitness before their operation. The ExPO team has developed a pre-operative Personalised Exercise Programme (my-PEP), specifically for patients undergoing oesophagectomy. my-PEP has 4 main components: three are exercise modalities (aerobic exercise, breathing exercises and muscle strengthening); the fourth is where a participant's potential barriers to exercise are assessed and behavioural change techniques (BCTs) are suggested to improve exercise engagement in the trial. In total, 32 patients who are due to undergo oesophagectomy at the Norfolk and Norwich Hospital will be recruited and then randomly divided into 2 arms of 16 each. One arm will receive my-PEP in the standard 3-4 months prior to surgery, the other will receive standard care advice to exercise at home. The research objectives are to obtain feasibility data on whether my-PEP is acceptable, adhered to and safe, and whether it improves patient fitness above standard care. Follow up will be 90 days after surgery to obtain a preliminary imprecise estimate of whether my-PEP reduces complications. If the ExPO trial shows promise in these areas, this will inform and justify a future large multi-centre trial to definitively answer whether my-PEP can reduce complications after oesophagectomy. If so, my-PEP could potentially change and improve the pre-operative management of oesophageal cancer patients across the NHS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
32
A pre-operative personalised exercise programme (my-PEP) consisting of: 1) actions to promote exercise, using behavioural change techniques (BCTs), 2) home inspiratory muscle training (IMT), 3) a home exercise programme (HEP) - which is also current standard care, 4) a 4 week hospital-supervised aerobic and muscle strengthening programme (Hos-PEP) .
Written advice on exercise at home
University of East Anglia
Norwich, Norfolk, United Kingdom
RECRUITINGRecruitment rate
The number of participants recruited from all eligible patients
Time frame: 0 months
Drop-out rate
Number of patients that drop-out from trial
Time frame: 12 months
Decline rate
Number of patients that decline to participate in the trial
Time frame: 0 months
Change in physical activity levels
Measured with International Physical Activity Questionnaire (IPAQ)
Time frame: 0 and 4 months
Change in attitudes to exercise
Measured with Determinates of Physical Activity Questionnaire (DPAQ)
Time frame: 0 and 4 months
Trial Adherence
Physical activity diary used to assess adherence
Time frame: 12 months
Adverse Events
The number of adverse events during the trial assessed using CTCAE
Time frame: 12 months
Change in physiological fitness
Assessed with maximal cardiopulmonary exercise test on a bicycle ergometer
Time frame: 0 and 4 months
Change in respiratory muscle strength
Assessed with mean inspiratory pressure testing in cmH20
Time frame: 0 and 4 months
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Post-operative cardiopulmonary complications
Cardiopulmonary complication rates as per ECCG definition.
Time frame: 90-days post surgery
Post-operative non-cardiopulmonary complications
Inpatient, 30-day and 90-day non-cardiopulmonary complication rates as per ECCG definition.
Time frame: 90-days post surgery
Post-operative length of stay
Duration of post-operative stay in days
Time frame: 90-days post surgery
Post-operative mortality
Number of post-operative deaths
Time frame: 90-days post surgery
Change in Quality of Life
Assessed using QLQ C30 and OG25
Time frame: 0, 4, 7 months