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

ISRCTN	ISRCTN29696295
DOI	https://doi.org/10.1186/ISRCTN29696295
Secondary identifying numbers	35051

Submission date: 31/08/2017
Registration date: 19/09/2017
Last edited: 11/12/2020

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Mrs Emma Hedley
Public

Oxford Respiratory Trials Unit
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom

Phone	+44 1865 227456
Email	emma.hedley@ouh.nhs.uk

Study information

Study design	Randomised; Interventional; Design type: Treatment, Psychological & Behavioural, Physical, Rehabilitation
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	ISRCTN29696295_PIS_V1 0_07Jun2017.pdf
Scientific title	Reducing perioperative risk in chronic obstructive pulmonary disease with pre-operative pulmonary rehabilitation - A feasibility study
Study objectives	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(s)	Yorkshire & The Humber - South Yorkshire Research Ethics Committee, 17/07/2017, ref: 17/YH/0220
Health condition(s) or problem(s) studied	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
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 study start date	01/12/2016
Completion date	30/11/2019
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 72; UK Sample Size: 72
Total final enrolment	3
Key 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
Key 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
Date of first enrolment	16/10/2017
Date of final enrolment	06/03/2019

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

John Radcliffe Hospital

Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Oxford Health NHS Trust – Pulmonary Rehabilitation (Continuing care site)

63 Blackbird Leys Road
Blackbird Leys
Oxford
OX4 6HL
United Kingdom

Freeman Hospital

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

Sponsor information

University of Oxford
Hospital/treatment centre

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

"ROR"	https://ror.org/052gg0110

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	06/03/2020
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal.
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date please use this statement.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version V1	07/06/2017	26/10/2017	No	Yes
Preprint results	non-peer-reviewed results in preprint server:	06/11/2019	07/11/2019	No	No
Results article	results	09/03/2020	11/12/2020	Yes	No
HRA research summary			28/06/2023	No	No

Additional files

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

Editorial Notes

11/12/2020: Publication reference added.
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.