Condition category
Respiratory
Date applied
12/03/2018
Date assigned
15/03/2018
Last edited
06/07/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Pulmonary rehabilitation (PR) is an exercise and education programme for people with chronic lung disease that aims to improve fitness levels, breathlessness and quality of life. Most of the evidence to support PR has come from studies conducted in centres that use specialist exercise equipment such as treadmills, cycle ergometers, and specialist resistance equipment (PR-specialist). However, in clinical practice routine access to this equipment may not be feasible. In the 2015 Royal College of Physicians National Audit, it was identified that 81% of PR programmes in England and Wales were hosted in community sites and 59% of these probably did not have access to specialist equipment. Accordingly, exercise training at these sites was completed with minimal exercise equipment (PR-min), typically using simple, portable equipment such as free weights, walking programmes, and bodyweight resistance exercises. Apart from improving accessibility, it has been argued that PR-min may have other advantages over PR-specialist. Exercise training using minimal equipment may better reflect activities of daily living than training using specialist equipment, and therefore be easier to replicate and maintain at home following discharge from PR. However, there is a lack of studies examining the effectiveness of centre-based PR completed with minimal exercise equipment. The aim of this study is to determine whether an eight-week supervised PR programme using minimal exercise equipment (PR-min) is as effective as a standard eight-week supervised PR programme delivered using specialist exercise equipment (PR-specialist) in terms of health benefits for patients with chronic lung disease.

Who can participate?
Patients aged 18 and over with chronic lung disease

What does the study involve?
Participants are randomly allocated to either PR-min or PR-specialist for two supervised sessions per week for 8 weeks. Exercise capacity, breathlessness, quality of life, leg muscle strength and costs are measured at the start of the study, at 8 weeks and at 12 months.

What are the possible benefits and risks of participating?
It is hoped that minimal and specialist equipment pulmonary rehabilitation will improve walking ability, breathlessness and quality of life. However, it is not known whether minimal equipment pulmonary rehabilitation will provide as much benefit as specialist equipment pulmonary rehabilitation. The results of this study may provide the information to decide whether pulmonary rehabilitation using minimal equipment is as good as using specialist equipment. Therefore the research may benefit patients directly and provide more information in order to potentially help other people in the long term. This is a very low risk study. There is a very small risk of a sports-related injury but this will be minimised by performing warm-up exercises before the exercise part of the pulmonary rehabilitation programme.

Where is the study run from?
Harefield Hospital (UK)

When is the study starting and how long is it expected to run for?
November 2017 to July 2021

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Claire Nolan

Trial website

Contact information

Type

Scientific

Primary contact

Ms Claire Nolan

ORCID ID

http://orcid.org/0000-0001-9067-599X

Contact details

Harefield Hospital
Hill End Road
Harefield
UB9 6JH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

37582

Study information

Scientific title

MInimal versus SpecialisT Equipment in the delivery of pulmonary Rehabilitation (MISTER): a randomised controlled trial

Acronym

MISTER

Study hypothesis

Pulmonary rehabilitation (PR) is an exercise and education programme for people with chronic lung disease that aims to improve fitness levels, breathlessness and quality of life. The majority of evidence to support PR has come from trials conducted in centres that utilise specialist exercise equipment such as treadmills, cycle ergometers, and specialist resistance equipment (PR-specialist). However, in clinical practice routine access to this equipment may not be feasible. In the 2015 Royal College of Physicians National Audit, it was identified that 81% of PR programmes in England and Wales were hosted in community sites and 59% of these probably did not have access to specialist equipment. Accordingly, exercise training at these sites was completed with minimal exercise equipment (PR-min), typically using simple, portable equipment such as free weights, walking programmes, and bodyweight resistance exercises.

Apart from improving accessibility, it has been argued that PR-min may have other advantages over PR-specialist. Exercise-training using minimal equipment may better reflect activities of daily-living than training using specialist equipment, and therefore be easier to replicate and maintain at home following discharge from PR. However, there is a paucity of robust literature examining the efficacy of centre-based PR completed with minimal exercise equipment. The aim of this research is to determine whether an eight-week supervised PR programme using minimal exercise equipment (PR-min) is non-inferior to a standard eight-week supervised PR programme delivered using specialist exercise equipment (PR-specialist) in terms of health benefits for patients with chronic lung disease.

Ethics approval

London – Camden and Kings Cross Research Ethics Committee, 12/03/2018, 18/LO/0315

Study design

Randomised; Interventional; Design type: Treatment, Rehabilitation

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 to request a patient information sheet

Condition

Specialty: Respiratory disorders, Primary sub-specialty: Chronic Obstructive Pulmonary Disease; UKCRC code/ Disease: Respiratory/ Chronic lower respiratory diseases

Intervention

This study is a parallel, two-group, assessor- and statistician-blinded, randomised trial. The method of randomisation is minimisation. Consenting participants will be randomised at the individual level with a 1:1 allocation, using an independent web-based system provided by the United Kingdom Clinical Research Collaboration registered King’s Clinical Trials Unit (CTU) to either an eight-week supervised PR programme using minimal exercise equipment (PR-min) or a standard eight-week supervised PR programme delivered using specialist exercise equipment (PR-specialist). Both interventions will comprise two supervised sessions per week for eight weeks delivered by the same team. Outcome measures will be recorded at initial assessment for PR, following PR at 8 weeks and at 12 months.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Exercise capacity measured by the incremental shuttle walk test distance at baseline and 8 weeks

Secondary outcome measures

1. Breathlessness measured using the Chronic Respiratory Questionnaire (CRQ) – dyspnoea domain at baseline, 8 weeks and 12 months
2. Disease-specific health-related quality of life measured using the CRQ at baseline, 8 weeks and 12 months
3. Lower limb muscle strength measured using isometric quadriceps maximum voluntary contraction at baseline, 8 weeks and 12 months
4. Trial process details: number of patients recruited to the trial; proportion of patients that uptake, adhere to and complete PR; reasons for PR non-completion and proportions of patients satisfaction levels on the GROC. This information will be collected in each arm of the study, at the appropriate stage of the trial e.g. baseline, 8 weeks and 12 months
5. The cost and cost-effectiveness of the intervention from the perspective of the NHS using the Modified Service Receipt Inventory, quality-adjusted life years using the Euro-Qol 5 Dimensions 5 Levels questionnaire utility index and healthcare resource usage data obtained from NHS Digital at baseline and 12 months

Amended 06/07/2018: last timepoint corrected from 14 months to 12 months.

Overall trial start date

01/11/2017

Overall trial end date

31/07/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age range: 18 to 100 years
2. Gender: male and female
3. Physician diagnosis of stable chronic respiratory disease, typically COPD, interstitial lung disease, bronchiectasis, chronic asthma or chest wall disease with no change in medication in past 6 weeks
4. Referred for PR in line with British Thoracic Society guidelines (i.e. ambulatory – can walk ≥5 metres, functional impairment related to breathlessness, typically MRC dyspnoea score ≥2)
5. Able to communicate verbally and respond to questions in written English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 362; UK Sample Size: 362

Participant exclusion criteria

1. Contra-indication to moderate intensity physical exercise e.g. unstable cardiovascular disease
2. Progressive cancer or neurological disorder with expected life expectancy less than 12 months
3. Completed PR within previous 12 months
4. Unable to provide informed consent

Recruitment start date

01/08/2018

Recruitment end date

31/01/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Harefield Hospital
Hill End Road
Harefield
UB9 6JH
United Kingdom

Sponsor information

Organisation

Royal Brompton & Harefield NHS Foundation Trust

Sponsor details

Royal Brompton Hospital
Sydney Street
London
SW3 6NP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: PB-PG-0816-20022

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. The trialists plan to submit the protocol for peer review in an open access journal.
2. The results of this study will be published in a high-impact peer reviewed journal in 2021
3. All participants will be offered feedback on the study results (when they are published) via a letter, as specified in the consent form. They will also be invited to a research open day showcasing the latest research projects at Royal Brompton and Harefield Hospital. This will take place in 2021
4. Dissemination to charities with an interest in IPF e.g. British Lung Foundation, Asthma UK Action for Pulmonary Fibrosis. This will take place in 2021
5. Dissemination via Patient and Public Involvement routes: electronic newsletters of the collaborating local patient groups (Breathe Support Group, Breathe Easy Clubs, Singing for Breathing group) and at NIHR CLAHRC Collaborative Learning Delivery events. This will take place in 2021
6. Dissemination via social media: Twitter (accounts held by the Chief Investigator, the Royal Brompton and Harefield NHS Foundation Trust and the NIHR). This will take place in 2021

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available as consent was not sought from participants to share their data in this manner

Intention to publish date

31/12/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/07/2018: The secondary outcome measures were amended. 22/06/2018: The recruitment start date was changed from 01/05/2018 to 01/08/2018.