Condition category
Respiratory
Date applied
20/03/2017
Date assigned
08/05/2017
Last edited
08/05/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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?
1. The Royal Victoria Infirmary Hospital (UK)
2. Marie Curie Hospice Care (UK)

When is the study starting and how long is it expected to run for?
April 2016 to April 2023

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)

Trial website

Contact information

Type

Scientific

Primary contact

Mr Maher AlQuaimi

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

Type

Scientific

Additional contact

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

Type

Scientific

Additional contact

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

Type

Scientific

Additional contact

Dr Anne-Marie Bourke

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The feasibility of respiratory muscle training as part of an interstitial lung disease pulmonary rehabilitation programme

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

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/04/2016

Overall trial end date

01/04/2023

Reason abandoned

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

Patient

Age group

Adult

Gender

Both

Target number of participants

36

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

United Kingdom

Trial participating centre

The Royal Victoria Infirmary Hospital
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Trial 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
United Kingdom

Sponsor type

University/education

Website

http://www.ncl.ac.uk/icm/

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.

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

Intention to publish date

01/04/2024

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes