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
Contact information
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
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
35051
Study information
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)
Eligibility
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
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
30/09/2019
Locations
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
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
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
30/11/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN29696295_PIS_V1 0_07Jun2017.pdf Uploaded 26/10/2017