Reducing the perioperative risk to patients suffering from COPD with pre-operative pulmonary rehabilitation

Plain English Summary

Background and study aims
COPD (chronic obstructive pulmonary disease) is a group of lung conditions that make it difficult to breathe due to narrowed airways. It is well known that people with COPD have more complications following surgery, and this study intends to test whether we can reduce that. It is also well known that pulmonary rehabilitation (a programme of exercise, education and support to help improve breathing) has very powerful effects upon breathlessness and quality of life in people with COPD, and reduces hospitalisations and deaths following exacerbations (flare ups) of COPD. Therefore it would be helpful to see if pulmonary rehabiliation can reduce complications following surgery. The aim of the study is to see whether it would be feasible to undertake a larger randomised control trial to assess whether offering pulmonary rehabilitation to participants prior to surgery will improve their recovery rate after surgery.

Who can participate?
Adults aged 18 and older who have COPD.

What does the study involve?
Participants who consented are randomly allocated to one of two groups. Those in the first group receive advice on smoking cessation, exercise and appropriate referral and education for those with newly diagnosed COPD. Those in the second group attending three sessions of pulmonary rehabilitation each week in the three weeks prior to their surgery, each session would last approximately two hours. In both groups participants are asked to complete questions and attend follow up visits.

What are the possible benefits and risks of participating?
Participants may benefit from reducing the post-operative pulmonary complications which allows them to return to normal every day activities more quickly. There are no risks to taking part in this study.

Where is the study run from?
This study is being run by the University of Oxford (UK) and takes place in John Radcliffe Hospital (UK), Oxford Health NHS Trust – Pulmonary Rehabilitation (Continuing care site) (UK) and the Freeman Hospital (UK).

When is the study starting and how long is it expected to run for?
December 2016 to November 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Mrs Emma Hedley
emma.hedley@ouh.nhs.uk

Trial website

Type

Public

Primary contact

Mrs Emma Hedley

ORCID ID

Contact details

Oxford Respiratory Trials Unit
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
+44 1865 227456
emma.hedley@ouh.nhs.uk

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

35051

Scientific title

Reducing perioperative risk in chronic obstructive pulmonary disease with pre-operative pulmonary rehabilitation - A feasibility study

Acronym

Study hypothesis

The aim of the study is to see whether providing a suitably tailored course of pulmonary rehabilitation, delivered prophylactically to surgical patients with COPD would reduce post-operative pulmonary complications and will facilitate patients returning to normal every day activities more quickly.

Ethics approval

Yorkshire & The Humber - South Yorkshire Research Ethics Committee, 17/07/2017, ref: 17/YH/0220

Study design

Randomised; Interventional; Design type: Treatment, Psychological & Behavioural, Physical, Rehabilitation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Perioperative Medicine and Pain Management

Intervention

Participants are randomised to either the control arm or the treatment arm.

Control Arm: Participants receive standard care which includes advice on smoking cessation, exercise and appropriate referral and education for those with newly diagnosed COPD.

Treatment Arm: Participant attends three sessions of pulmonary rehabilitation each week in the three weeks prior to their surgery, each session would last approximately two hours.

In both arms participants are asked to complete questions and attend follow up visits are per the schedule.

Intervention type

Other

Phase

Drug names

Primary outcome measure

As this is a feasibility study the primary outcomes are measured throughout the study include:
1. Recruitment rates
2. Demographics of recruited participants
3. Treatment compliance
4. Suitability of outcome data

Secondary outcome measures

Incidence of postoperative pulmonary complications for those participants receiving rehab v those that did not this is measured on day 7 following surgery.

Overall trial start date

01/12/2016

Overall trial end date

30/11/2019

Reason abandoned (if study stopped)

Participant recruitment issue

Participant inclusion criteria

1. Adult patients, male and female aged 18 years or older with COPD
2. Has capacity to take part in this study
3. Scheduled for elective major (body cavity) surgery OR laparascopic surgery anticipated to last longer than two hours

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 72; UK Sample Size: 72

Total final enrolment

3

Participant exclusion criteria

1. Inability to give informed consent
2. Insufficient command of English to understand the study documentation
3. Unable to participate in pulmonary rehabilitation treatment according to British Thoracic Society guidelines
4. Patients scheduled cardiac, thoracic and orthopaedic surgery and orthopaedic surgery
5. If the participant attends a pulmonary rehab course as clinical management (as opposed to being part of the trial) then they would be excluded from the study

Recruitment start date

16/10/2017

Recruitment end date

06/03/2019

Countries of recruitment

United Kingdom

Trial participating centre

John Radcliffe Hospital
Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Oxford Health NHS Trust – Pulmonary Rehabilitation (Continuing care site)
63 Blackbird Leys Road Blackbird Leys
Oxford
OX4 6HL
United Kingdom

Trial participating centre

Freeman Hospital
Freeman Road High Heaton
Newcastle Upon Tyne
NE7 7DN
United Kingdom

Organisation

University of Oxford

Sponsor details

Research Services
CTRG
Joint Research Office
Block 60
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date please use this statement.

Intention to publish date

06/03/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2019 non-peer-reviewed results in preprint server: https://doi.org/10.1101/19007914 (added 07/11/2019)

Publication citations

• ISRCTN29696295_PIS_V1 0_07Jun2017.pdf Uploaded 26/10/2017

07/11/2019: The following changes have been made: 1. Publication reference added. 2. The overall trial status has been changed to 'Stopped'. 18/10/2019: The following changes have been made: 1. The recruitment end date has been changed from to 06/03/2019. 2. The recruitment status has been changed to 'Stopped'. 3. The final enrolment number has been added. 4. The intention to publish date has been changed from 30/11/2020 to 06/03/2020. 03/04/2019: The condition has been changed from "Specialty: Anaesthesia, perioperative medicine and pain management, Primary sub-specialty: Anaesthesia, Perioperative Medicine and Pain Management; UKCRC code/ Disease: Respiratory/ Chronic lower respiratory diseases" to "Perioperative Medicine and Pain Management" following a request from the NIHR. 26/10/2017: Internal review.