Postoperative Complications (Cardiopulmonary)ExPONCT02962219
Exercise Prior to Oesophagectomy
A study testing Pre-operative Exercise Programme (my-PEP) and Home Exercise Programme (HEP) in people with Postoperative Complications (Cardiopulmonary) and Oesophageal Adenocarcinoma, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications (Cardiopulmonary), Oesophageal Adenocarcinoma
- What is being tested?
- Pre-operative Exercise Programme (my-PEP) and Home Exercise Programme (HEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of East Anglia
Norwich, Norfolk, NR4 7TJ
Professor Andrew Hart, 01603 593611, a.hart@uea.ac.uk
Dr Stephen Lam, 01603 286286, stephen.lam@uea.ac.uk
About this study
Official title: 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
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.
Read the detailed description
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.
- Being tested
- Pre-operative Exercise Programme (my-PEP), Home Exercise Programme (HEP)
- Keywords
- oesophagectomy
- Medical subject headings
- Postoperative Complications, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative Exercise Programme (my-PEP)Behavioural
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) .
Home Exercise Programme (HEP)Behavioural
Written advice on exercise at home
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | A pre-operative personalised exercise programme (my-PEP). Receives: Behavioral: Pre-operative Exercise Programme (my-PEP) |
| Control | Other | Standard care Receives: Behavioral: Home Exercise Programme (HEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The number of participants recruited from all eligible patients
Measured: 0 months
Drop-out rate
Number of patients that drop-out from trial
Measured: 12 months
Decline rate
Number of patients that decline to participate in the trial
Measured: 0 months
Change in physical activity levels
Measured with International Physical Activity Questionnaire (IPAQ)
Measured: 0 and 4 months
Change in attitudes to exercise
Measured with Determinates of Physical Activity Questionnaire (DPAQ)
Measured: 0 and 4 months
Trial Adherence
Physical activity diary used to assess adherence
Measured: 12 months
Adverse Events
The number of adverse events during the trial assessed using CTCAE
Measured: 12 months
Change in physiological fitness
Assessed with maximal cardiopulmonary exercise test on a bicycle ergometer
Measured: 0 and 4 months
Change in respiratory muscle strength
Assessed with mean inspiratory pressure testing in cmH20
Measured: 0 and 4 months
Post-operative cardiopulmonary complications
Cardiopulmonary complication rates as per ECCG definition.
Measured: 90-days post surgery
Post-operative non-cardiopulmonary complications
Inpatient, 30-day and 90-day non-cardiopulmonary complication rates as per ECCG definition.
Measured: 90-days post surgery
Post-operative length of stay
Duration of post-operative stay in days
Measured: 90-days post surgery
Post-operative mortality
Number of post-operative deaths
Measured: 90-days post surgery
Change in Quality of Life
Assessed using QLQ C30 and OG25
Measured: 0, 4, 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Complications (Cardiopulmonary)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962219
- Sponsor's protocol ID
- 206608
- Acronym
- ExPO
- Status last verified
- Nov 2016
- First submitted
- 28 Oct 2016
- Last updated
- 11 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02962219
- Acronym / sponsor ID
- ExPO / 206608
- Keywords
- oesophagectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Pre-operative Exercise Programme (my-PEP)A pre-operative personalised exercise programme (my-PEP). |
| Control | Other | Behavioral: Home Exercise Programme (HEP)Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-operative Exercise Programme (my-PEP)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) . | Behavioural | Intervention |
| Home Exercise Programme (HEP)Written advice on exercise at home | Behavioural | Control |
Primary outcome
Recruitment rate
Time frame: 0 months
The number of participants recruited from all eligible patients
Drop-out rate
Time frame: 12 months
Number of patients that drop-out from trial
Decline rate
Time frame: 0 months
Number of patients that decline to participate in the trial
Change in physical activity levels
Time frame: 0 and 4 months
Measured with International Physical Activity Questionnaire (IPAQ)
Change in attitudes to exercise
Time frame: 0 and 4 months
Measured with Determinates of Physical Activity Questionnaire (DPAQ)
Trial Adherence
Time frame: 12 months
Physical activity diary used to assess adherence
Adverse Events
Time frame: 12 months
The number of adverse events during the trial assessed using CTCAE
Change in physiological fitness
Time frame: 0 and 4 months
Assessed with maximal cardiopulmonary exercise test on a bicycle ergometer
Change in respiratory muscle strength
Time frame: 0 and 4 months
Assessed with mean inspiratory pressure testing in cmH20
Post-operative cardiopulmonary complications
Time frame: 90-days post surgery
Cardiopulmonary complication rates as per ECCG definition.
Post-operative non-cardiopulmonary complications
Time frame: 90-days post surgery
Inpatient, 30-day and 90-day non-cardiopulmonary complication rates as per ECCG definition.
Post-operative length of stay
Time frame: 90-days post surgery
Duration of post-operative stay in days
Post-operative mortality
Time frame: 90-days post surgery
Number of post-operative deaths
Change in Quality of Life
Time frame: 0, 4, 7 months
Assessed using QLQ C30 and OG25
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-operative Exercise Programme (my-PEP) and Home Exercise Programme (HEP) in people with Postoperative Complications (Cardiopulmonary) and Oesophageal Adenocarcinoma, run by University of East Anglia at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 0 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2016.