Exercise Prior to Oesophagectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pre-operative Personalised Exercise Programme to Improve Physical Fitness and Reduce Post-operative Cardiopulmonary Complications After Oesophagectomy in Patients With Oesophageal Adenocarcinoma: A Feasibility Randomised Controlled Trial

Conditions
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Postoperative Complications (Cardiopulmonary), Oesophageal Adenocarcinoma

Intervention / Treatment
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* Behavioral: Pre-operative Exercise Programme (my-PEP)
* Behavioral: Home Exercise Programme (HEP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with oesophageal adenocarcinoma (OAC) who are scheduled for neoadjuvant chemotherapy and subsequent oesophagectomy. Must have histological evidence of OAC Must be capable of giving informed consent and complying with trial procedures. Exclusion Criteria: Patients with oesophageal squamous cell carcinoma. Patients with concomitant illness or disability that makes them unsuitable for an exercise programme, as determined by a clinician (e.g. severe musculoskeletal or neurological disease, unstable angina, severe aortic stenosis, uncontrolled dysrhythmias and uncompensated heart failure). WHO performance status 3 (capable of only limited self-care, confined to a bed or chair more that 50% of waking hours) or greater. Grade 5 (too breathless to leave the house, or breathless when undressing) on MRC dyspnoea scale.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>A pre-operative personalised exercise programme (my-PEP). | Behavioral: Pre-operative Exercise Programme (my-PEP)<br>* 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) .<br>|
| Other: Control<br>Standard care | Behavioral: Home Exercise Programme (HEP)<br>* Written advice on exercise at home<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | The number of participants recruited from all eligible patients | 0 months | 
| Drop-out rate | Number of patients that drop-out from trial | 12 months | 
| Decline rate | Number of patients that decline to participate in the trial | 0 months | 
| Change in physical activity levels | Measured with International Physical Activity Questionnaire (IPAQ) | 0 and 4 months | 
| Change in attitudes to exercise | Measured with Determinates of Physical Activity Questionnaire (DPAQ) | 0 and 4 months | 
| Trial Adherence | Physical activity diary used to assess adherence | 12 months | 
| Adverse Events | The number of adverse events during the trial assessed using CTCAE | 12 months | 
| Change in physiological fitness | Assessed with maximal cardiopulmonary exercise test on a bicycle ergometer | 0 and 4 months | 
| Change in respiratory muscle strength | Assessed with mean inspiratory pressure testing in cmH20 | 0 and 4 months | 
| Post-operative cardiopulmonary complications | Cardiopulmonary complication rates as per ECCG definition. | 90-days post surgery | 
| Post-operative non-cardiopulmonary complications | Inpatient, 30-day and 90-day non-cardiopulmonary complication rates as per ECCG definition. | 90-days post surgery | 
| Post-operative length of stay | Duration of post-operative stay in days | 90-days post surgery | 
| Post-operative mortality | Number of post-operative deaths | 90-days post surgery | 
| Change in Quality of Life | Assessed using QLQ C30 and OG25 | 0, 4, 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oesophagectomy