Trial of lung rehabilitation customised for interstitial lung disease

ISRCTN	ISRCTN92567676
DOI	https://doi.org/10.1186/ISRCTN92567676
Protocol serial number	N/A
Sponsor	Newcastle University
Funder	Royal Embassy of Saudi Arabia - Cultural Bureau in London

Submission date: 20/03/2017
Registration date: 08/05/2017
Last edited: 24/05/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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)

Contact information

Mr Maher Mubarak Al Quaimi
Scientific

King Faisal Ibn Abd Al Aziz, King Faysal University
Dammam
34212
Saudi Arabia

ORCID ID	0000-0002-7583-2624
Phone	None provided
Email	mmalquaimi@iau.edu.sa

Dr Christopher Ward
Scientific

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

ORCID ID	0000-0002-6954-9611
Phone	+44 (0)191 222 8460
Email	chris.ward@ncl.ac.uk

Dr Ian Forrest
Scientific

Royal Victoria Infirmary Newcastle upon Tyne
Department of Respiratory Medicine
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Phone	+44 (0)191 292 0149
Email	ian.forrest@nhs.net

Dr Anne-Marie Bourke
Scientific

Marie Curie Hospice
Marie Curie Drive
Newcastle upon Tyne
Newcastle upon Tyne
NE4 6SS
United Kingdom

Phone	+44 (0)191 2191000
Email	anne-mariebourke@nhs.net

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A proof of concept trial of pulmonary rehabilitation with inspiratory muscle training in interstitial lung disease in a hospice and home setting
Study objectives	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
Health condition(s) or problem(s) studied	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(s)	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
Key secondary outcome measure(s)	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
Completion date	10/03/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	36
Total final enrolment	34
Key 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
Key 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
Date of first enrolment	01/08/2017
Date of final enrolment	01/08/2022

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

The Royal Victoria Infirmary Hospital

Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Marie Curie Hospice

Marie Curie Drive
Newcastle upon Tyne
NE4 6SS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Other unpublished results			24/05/2024	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN92567676_UnpublishedResults.pdf: Other unpublished results

Editorial Notes

24/05/2024: Unpublished results uploaded.
21/05/2024: A study contact was updated.
12/04/2023: The following changes have been made:
1. The overall trial end date has been changed from 01/04/2023 to 10/03/2022 and the plain English summary updated accordingly.
2. The final enrolment number has been added.
16/06/2020: All of the scientific contacts' details are now publicly visible.
12/06/2020: Three of the scientific contacts' details have been made publicly visible.
26/11/2019: The scientific title was changed from "The feasibility of respiratory muscle training as part of an interstitial lung disease pulmonary rehabilitation programme" to "A proof of concept trial of pulmonary rehabilitation with inspiratory muscle training in interstitial lung disease in a hospice and home setting".
23/07/2018: Ethics approval details added.