Condition category
Respiratory
Date applied
05/06/2014
Date assigned
05/06/2014
Last edited
04/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Patients with interstitial lung disease (ILD) experience progressive breathlessness, tiredness and poor exercise capacity during their everyday life. As a result of these symptoms, patients tend to avoid strenuous activities and become less fit over time. This subsequently leads to even more breathlessness and tiredness during everyday activities. Pulmonary rehabilitation (PR) programmes are programmes of exercise and education that aim to break this vicious cycle and improve physical function, symptoms and self-management in ILD. A standard exercise regime in pulmonary rehabilitation involves moderate-intensity continuous training (MICT) for an hour with an increase in intensity as patients become fitter. High-intensity interval training (HIIT) is a type of exercise training shown in research studies to be superior to other types in heart failure patients and cancer survivors. Recently, HIIT was also shown to be effective in severe ILD patients before lung transplantation. In this study, we want to test the use of HIIT in pulmonary rehabilitation programmes for ILD patients and assess its long-term benefits compared to a standard exercise programme.

Who can participate?
Patients with any type and severity of ILD.

What does the study involve?
Participants are randomly allocated to one of two groups: either the active group undertaking HIIT or the control group undertaking standard exercise. They will be assessed on three occasions (before and after the pulmonary rehabilitation programme and 6 months later). We will assess exercise capacity, breathlessness, respiratory and muscle function, quality of life and patients' views about the programme. The pulmonary rehabilitation programme will take place twice weekly for 8 weeks.

What are the benefits and risks to participants?
All participants will receive a personalised programme of exercise during the pulmonary rehabilitation session and a home-based programme designed according to their individual needs. We expect that all patients will experience improvement in exercise capacity and breathlessness regardless of the group they belong to. If the intervention (HIIT) is successful, the active group is likely to experience additional benefits. All patients will benefit from the educational sessions that are part of the pulmonary rehabilitation programme. Another benefit for patients is that they will be able to express their views about their programme and care and will be encouraged to set goals to improve their quality of life. Again, this benefit is independent of the group the patients will belong to. There are no major anticipated risks from the programme and all assessments are non-invasive. Both groups, active and control, will receive the standard treatment (pulmonary rehabilitation). Both types of training have been shown to be safe in other patient groups (such as patients with heart failure) and HIIT has also been shown to be safe in severe ILD patients. We will be monitoring all parameters during exercise and patients will be able to stop if they feel discomfort. As one of the aims of this study is to monitor how long it takes for patients to reach high intensity of training and how well it is tolerated, we anticipate that extreme discomfort or pain will not occur. Patients may feel breathless during the programme but will be advised to take a break if breathlessness becomes very severe. Cardiopulmonary exercise testing (CPET) always carries a small risk of adverse effects but these are rare in patients with respiratory disease as the limitation to exercise performance is usually related to breathlessness rather than cardiac function.

When does the study take place?
The study started in March 2014 and runs until December 2015.

Where does the study take place?
The study take place at the Clinical Research Facilities and pulmonary rehabilitation gym of St George's University and St George's Hospital NHS Trust, London, UK.

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

Who is the main contact?
Dr Dimitra Nikoletou
d.nikoletou@sgul.kingston.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dimitra Nikoletou

ORCID ID

Contact details

Cranmer Terrace
London
SW17 0RE
United Kingdom
-
d.nikoletou@sgul.kingston.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16597

Study information

Scientific title

Feasibility of high intensity interval training in pulmonary rehabilitation programmes for patients with interstitial lung disease and preliminary efficacy of its long-term benefits

Acronym

HIIT in PR for ILD; a feasibility study

Study hypothesis

Patients with interstitial lung disease (ILD) experience progressive breathlessness, fatigue and poor exercise capacity during their everyday life. As a result of these symptoms, patients tend to avoid strenuous activities and become less fit over time. This subsequently leads to even more breathlessness and fatigue during everyday activities.
Pulmonary rehabilitation (PR) programmes are programmes of exercise and education that aim to break this vicious cycle and improve physical function, symptoms and self-management in ILD. A standard exercise regime in pulmonary rehabilitation involves moderate-intensity continuous training for an hour with an increase in intensity as patients become fitter.
High-intensity interval training (HIIT) is a type of exercise training shown in research studies to be superior to other types in heart failure patients and cancer survivors. Recently, HIIT was also shown to be effective in severe ILD patients before lung transplantation.
In this study, we intend to assess the feasibility of using HIIT in pulmonary rehabilitation programmes for ILD patients and assess its long-term benefits compared to a standard exercise programme. We will study 60 patients with various types of ILD who are referred to pulmonary rehabilitation and examine the recruitment, adherence and retention to our HIIT programme in comparison with a standard programme. We will also assess the long-term benefits (6 months later) of the HIIT versus standard exercise training on exercise capacity, breathlessness and quality of life. This study will provide important information to design a larger, definitive study and will inform the design of more focused exercise regimes for patients with different types of ILD.

More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=16597

Ethics approval

14/LO/0149; First MREC approval date 14/02/2014

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Respiratory disorders; Subtopic: Respiratory (all Subtopics); Disease: Respiratory

Intervention

HIIT in PR Active group: Patients in this group will train in a pulmonary rehabilitation programme using high-intensity interval training
MICT in PR Control group: Patients in the control group will train using moderate-intensity continuous training during their pulmonary rehabilitation programme

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Exercise capacity: 6MWT; Timepoint(s): Pre-PR, Post-PR and 6 months after PR

Secondary outcome measures

1. Breathlessness; Timepoint(s): Pre-PR, Post-PR and 6 months post PR
2. Feasibility measures (recruitment/adherence/retention); Timepoint(s): Post-PR, 6 months later
3. Quality of Life questionnaires; Timepoint(s): Pre-PR, Post-PR and 6 months later
4. Respiratory and peripheral muscle function; Timepoint(s): Pre-PR, Post-PR and 6 months later
5. VO2max-CPET; Timepoint(s): Pre-PR, post-PR and 6 months later
6. In-depth interviews; Timepoint(s): Pre-PR, post-PR and 6 months later

Overall trial start date

02/05/2014

Overall trial end date

17/03/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with varying severity of ILD (all types apart from sarcoidosis will be included). The type and severity of participants will be recorded
2. Patients whose first language is not English (we will provide interpreters to explain educational presentations and other instructions as per usual clinical practice)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant exclusion criteria

1. Patients with sarcoidosis
2. Patients with significant comorbidities (musculoskeletal, cardiac or neurological) that interfere with patients' ability to exercise

Recruitment start date

12/06/2014

Recruitment end date

31/01/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St George's University of London (UK)
London
SW17 0RE
United Kingdom

Sponsor information

Organisation

St George's University of London (UK)

Sponsor details

Research Office
Cranmer Terrace
London
SW17 0RE
United Kingdom
-
nazzouzi@sgul.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

On 02/12/2014 the overall trial end date was changed from 30/12/2015 to 17/03/2016. On 04/01/2016 the recruitment end date was changed from 30/12/2015 to 31/01/2016.