Minimal versus specialist equipment in the delivery of pulmonary rehabilitation
| ISRCTN | ISRCTN16196765 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16196765 |
| Secondary identifying numbers | CPMS 37582 |
- Submission date
- 12/03/2018
- Registration date
- 15/03/2018
- Last edited
- 19/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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 March 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Claire Nolan
Contact information
Scientific
Harefield Hospital
Hill End Road
Harefield
UB9 6JH
United Kingdom
 ORCID ID |
0000-0001-9067-599X |
|---|
Study information
| Study design | Randomized; Interventional; Design type: Treatment, Rehabilitation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | MInimal versus SpecialisT Equipment in the delivery of pulmonary Rehabilitation (MISTER): a randomised controlled trial |
| Study acronym | MISTER |
| Study objectives | 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(s) | London – Camden and Kings Cross Research Ethics Committee, 12/03/2018, ref: 18/LO/0315 |
| Health condition(s) or problem(s) studied | Chronic respiratory disease |
| 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 | Behavioural |
| 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 study start date | 01/11/2017 |
| Completion date | 14/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 432 |
| Total final enrolment | 436 |
| Key inclusion criteria | Current inclusion criteria as of 27/03/2019: 1. Age range: 18 years and over (updated 02/08/2018) 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 (updated 27/03/2019) 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 _____ Previous 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 |
| Key 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 |
| Date of first enrolment | 15/10/2018 |
| Date of final enrolment | 21/12/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Harefield
UB9 6JH
United Kingdom
Sponsor information
Hospital/treatment centre
Royal Brompton Hospital
Sydney Street
London
SW3 6NP
England
United Kingdom
"ROR" |
https://ror.org/02218z997 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | 1. The results of this study will be published in a high-impact peer reviewed journal 2. 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. 3. Dissemination to charities with an interest in IPF e.g. British Lung Foundation, Asthma UK Action for Pulmonary Fibrosis. 4. 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. 5. Dissemination via social media: Twitter (accounts held by the Chief Investigator, the Royal Brompton and Harefield NHS Foundation Trust and the NIHR). |
| IPD sharing plan | 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 18/10/2021 | 06/07/2023 | Yes | No | |
| Statistical Analysis Plan | version 2.0 | 26/04/2023 | 13/11/2023 | No | No |
Additional files
Editorial Notes
19/12/2024: The intention to publish date was changed from 31/12/2024 to 30/06/2025.
14/05/2024: The intention to publish date was changed from 31/05/2024 to 31/12/2024.
09/01/2024: The intention to publish date was changed from 31/12/2023 to 31/05/2024.
13/11/2023: A SAP file has been uploaded.
06/07/2023: The following changes were made to the study record:
1. Publication reference added.
2. Contact details updated.
3. The recruitment end date was changed from 30/09/2023 to 21/12/2021.
09/06/2023: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2022 to 14/12/2022.
2. The intention to publish date was changed from 31/12/2022 to 31/12/2023.
08/12/2022: The following changes were made to the trial record:
1. The overall end date was changed from 31/03/2023 to 31/12/2022.
2. The intention to publish date was changed from 23/12/2021 to 30/09/2023.
3. The plain English summary was updated to reflect these changes.
4. The contact email was updated.
10/01/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/03/2022 to 23/12/2021.
2. The final enrolment number has been added.
17/06/2021: Recruitment for this study is no longer paused and the following changes have been made:
1. The recruitment end date has been changed from 31/03/2021 to 31/03/2022.
2. The overall trial end date has been changed from 31/03/2022 to 31/03/2023 and the plain English summary has been updated to reflect this change.
3. The target number of participants has been updated from Planned Sample Size: 436; UK Sample Size: 436 to 432 and the total target enrolment has been updated to reflect this change.
24/02/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2020 to 31/03/2021.
2. The overall end date was changed from 31/07/2021 to 31/03/2022.
3. The intention to publish date was changed from 31/12/2021 to 31/12/2022.
4. The target number of participants was changed from Planned Sample Size: 362; UK Sample Size: 362 to Planned Sample Size: 436; UK Sample Size: 436.
5. The plain English summary was updated to reflect these changes.
6. Due to current public health guidance, recruitment for this study has been paused.
11/02/2020: The recruitment end date has been changed from 31/01/2020 to 31/03/2020.
04/04/2019: The condition has been changed from "Chronic Obstructive Pulmonary Disease" to "Chronic respiratory disease".
27/03/2019: The condition has been changed from "Specialty: Respiratory disorders, Primary sub-specialty: Chronic Obstructive Pulmonary Disease; UKCRC code/ Disease: Respiratory/ Chronic lower respiratory diseases" to "Chronic Obstructive Pulmonary Disease" following a request from the NIHR.
27/03/2019: The inclusion criteria were amended.
22/10/2018: The recruitment start date was changed from 01/08/2018 to 15/10/2018.
02/08/2018: The inclusion criteria were amended.
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.
