Plain English Summary
Background and study aims
Idiopathic pulmonary fibrosis (IPF) is a disease where the lungs scar for unknown reasons making breathing difficult. IPF has a high mortality rate (death rate) of 50% in the first five years after being diagnosed. The current IPF treatments do not lead to major changes in quality of life or improve chances of survival. It is known that patients with lung disease overall are less healthy and usually become “out of shape”. Exercises and pulmonary rehabilitation (exercises to improve breathing) are known to help patients with other lung diseases but there are few studies to see if patients with IPF could benefit from this type of treatment. The aim of this study is to develop a pulmonary rehabilitation for patients with IPF that includes education, exercise, breathing and relaxation techniques, as well as nutritional and psychological (mental) instructions.
Who can participate?
Adults aged 40 and older who are diagnosed with IPF.
What does the study involve?
Participants are asked to fill out a questionnaire about breathlessness, their quality of life and their levels of tiredness. They also undergo a walking test, breathing test, muscle force test, blood tests and breathing muscles test. Participants are then randomly allocated to one of two groups. Those in the first group undergo a weekly programme that includes home exercises, walking exercises and one supervised session of education, exercises and relaxation. This is done eight weeks. Those in the second group undergo the same eight week programme as the first group but they also receive respiratory muscle training (breathing training) twice a day for 30 breaths long. Participants then repeat the assessments from the beginning of the study to see if they have any changes in their breathing ability and their health levels.
What are the possible benefits and risks of participating?
There are no notable benefits or risks with participating. Participants may feel some discomfort when giving blood samples.
Where is the study run from?
Newcastle University (UK)
When is the study starting and how long is it expected to run for?
April 2016 to March 2022
Who is funding the study?
Royal Embassy of Saudi Arabia - Cultural Bureau in London (UK)
Who is the main contact?
1. Mr Maher AlQuaimi (Scientific)
2. Dr Christopher Ward (Scientific)
3. Dr Ian Forrest (Scientific)
4. Dr Anne-Marie Bourke (Scientific)
Study website
Contact information
Type
Scientific
Contact name
Mr Maher Al Quaimi
ORCID ID
http://orcid.org/0000-0002-7583-2624
Contact details
Newcastle University
IcaMB 2.056
Leech Building Medical School
Newcastle upon Tyne
NE2 4HH
United Kingdom
+44 (0)749 079 5121
M.M.S.Al-Quaimi2@newcastle.ac.uk
Type
Scientific
Contact name
Dr Christopher Ward
ORCID ID
http://orcid.org/0000-0002-6954-9611
Contact details
Newcastle University
Institute of Cellular Medicine (Respiratory) and ICaMB
Cookson 1.072 Floor 1
Cookson Building Medical School
Newcastle upon Tyne
NE2 4HH
United Kingdom
+44 (0)191 222 8460
chris.ward@ncl.ac.uk
Type
Scientific
Contact name
Dr Ian Forrest
ORCID ID
Contact details
Royal Victoria Infirmary Newcastle upon Tyne
Department of Respiratory Medicine
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
+44 (0)191 292 0149
ian.forrest@nhs.net
Type
Scientific
Contact name
Dr Anne-Marie Bourke
ORCID ID
Contact details
Marie Curie Hospice
Marie Curie Drive
Newcastle upon Tyne
Newcastle upon Tyne
NE4 6SS
United Kingdom
+44 (0)191 2191000
anne-mariebourke@nhs.net
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A proof of concept trial of pulmonary rehabilitation with inspiratory muscle training in interstitial lung disease in a hospice and home setting
Acronym
Study hypothesis
1. A tailored rehabilitation program for Interstitial lung disease (ILD) and Idiopathic pulmonary fibrosis (IPF) is feasible
2. A tailored hybrid rehabilitation program (home setting, hospice care setting) for ILD and IPF is feasible
3. An inspiratory muscle training is feasible in ILD and IPF
Ethics approval(s)
Health Research Authority, NHS, UK, 03/04/2018, ref: 18/NE/0037
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Interstitial lung disease including idiopathic pulmonary fibrosis
Intervention
Participants are randomly allocated to one of two groups using a computer generated randomisation list.
Control Group (Group 1): Those in the first group receive a tailored rehabilitation programme for eight weeks. This involves a repeated weekly programme consisting of two unsupervised home exercise sessions, four days of targeted walking exercises and one supervised session. The supervised session consists of an education talk followed by an exercise session and a relaxation session. This is done in a hospice care setting.
Intervention Group (Group 2): Those in the second group do the same as the first group. In addition, they receive respiratory muscle training taking place at 40% of inspiratory muscle pressure. This is done twice a day and each session will be 30 breaths long.
Participants are also asked to fill out questionnaires on breathlessness, quality of life and fatigue prior to the the study and after the study. They also are assessed using a walking test, breathing test, muscle force test, blood extraction, and breathing muscles force test prior to the study and after the study.
Intervention type
Behavioural
Primary outcome measure
1. Number of people recruited is measured using the study records at baseline and eight weeks
2. Number of people who complete the study is measured using study records at baseline and eight weeks
Secondary outcome measures
1. Inspiratory muscle pressure (IMP) is measured using the POWERbreathe KH2 machine at baseline and eight weeks
2. Palliative care needs (patients' physical symptoms, psychological, emotional and spiritual, and information and support needs) is measured using the palliative care outcome scale (IPOS) at week one, two, three, four, five, six, seven and eight.
3. Breathlessness and other symptoms of IPF are measured using the K-Bild questionnaire at baseline and eight weeks
4. Quadriceps, elbow, and shoulder muscles strength is measured using microFET device at baseline and eight weeks
5. Anxiety and depression is measured using the Hospital anxiety and Depression Scale at baseline and eight weeks
6. Biomarkers are measured using blood samples at baseline and eight weeks
7. Fatigue is measured using the Fatigue Severity Scale at baseline and eight weeks
8. Lung volumes and capacities are measured using spirometry at baseline and eight weeks
9. Lung diffusion capacity is measured using the diffusion capacity to carbon monoxide at baseline and eight weeks
10. Walking distance assessment is measured using the six-minute walk test at baseline and eight weeks
Overall study start date
01/04/2016
Overall study end date
10/03/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Working diagnosis of IPF or ILD made by a multi-disciplinary team
2. MRC dyspnoea score is between 2 to 5
3. Aged 40 or older
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
36
Total final enrolment
34
Participant exclusion criteria
1. Uncontrolled hypertension
2. Uncontrolled cardiac disease
3. Inability to perform exercises, for example: neuromuscular or orthopeaedic diseases
4. Inability to follow instructions, for example: learning difficulty
5. Inability to commit to transportation to the exercise facility during the study
6. Participation in pulmonary rehabilitation in the last 6 months
7. History of syncope on exertion
Recruitment start date
01/08/2017
Recruitment end date
01/08/2022
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
The Royal Victoria Infirmary Hospital
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
Study participating centre
Marie Curie Hospice
Marie Curie Drive
Newcastle upon Tyne
NE4 6SS
United Kingdom
Sponsor information
Organisation
Newcastle University
Sponsor details
Institute of Cellular Medicine
4th Floor
William Leech Building
Medical School
Framlington Place
Newcastle upon Tyne
NE2 4HH
England
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Royal Embassy of Saudi Arabia - Cultural Bureau in London
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
Intention to publish date
01/04/2024
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Maher AlQuaimi, malquimi@gmail.com
IPD sharing plan summary
Available on request
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
HRA research summary | 28/06/2023 | No | No |