Condition category
Respiratory
Date applied
17/05/2013
Date assigned
17/05/2013
Last edited
17/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
There are many exercise tests available that can measure how limited a person's activities are with Chronic Obstructive Pulmonary Disease (COPD). These exercise tests are also commonly used to measure improvements following therapies such as inhaled medications and rehabilitation programmes. The exercise tests vary a great deal and range from laboratory based systems through to tests requiring little equipment. This study aims to conduct an in depth comparison of the most frequently used exercise tests used to assess functional capacity in patients with COPD. This study looks at the exercise tests before and after a 6 week intervention (treatment) of either inhaled medication, pulmonary rehabilitation or no intervention (control group). The study compares the overall change in the test measures performed before and after the intervention. It is hoped that the results of this study will provide a greater understanding of how good the tests are at measuring results from an intervention, to guide further studies and clinical practice.

Who can participate?
Patients aged 40 - 85 with a diagnosis of COPD who walk slower due to breathlessness, or have to stop for breath when walking at their own pace

What does the study involve?
Participants undertake two laboratory based cycle tests and five other tests including three walking tests, one leg strength test and one test measuring physical performance (i.e. balance and standing from a chair). The study involves 5 visits to the hospital over a period of approximately 7-9 weeks. Participants are randomly allocated to one of the three groups to receive 6 weeks of an intervention followed by two further visits for final data collection. Group 1 receive inhaled medication, group 2 receive pulmonary rehabilitation and group 3 receive no intervention (control group). Participants are also asked to wear an activity monitor at the start and end of the trial for a period of 7 days.

What are the possible benefits and risks of participating?
There are no direct benefits of participating in this study. However, by taking part in this research, people will be contributing to the development and understanding of exercise testing in COPD. If patients are allocated to the rehabilitation group they may feel a benefit from the exercise programme. For those patients who are not allocated to the pulmonary rehabilitation group, it will be offered to them at the end of the study at the discretion of the patient and their doctor. The effects and discomforts of each test are described in the patient information sheet. The risks of completing the exercise tests are very low. When completing a maximal CPET there is a possible risk of collapse due to rapid heart rate but if patients have collapsed previously when exercising they are not asked to participate. Participants may become breathless when completing all of the tests but this is not dangerous and is a normal reaction to testing.

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

When is the study starting and how long is it expected to run for?
March 2013 to August 2017

Who is funding the study?
The study is being funded through the Medical Research Council (MRC) and pharmaceutical industry partners

Who is the main contact?
Theresa Harvey-Dunstan
theresa.harvey-dunstan@uhl-tr.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Theresa Harvey-Dunstan

ORCID ID

Contact details

Groby Road
Leicester
LE3 9QP
United Kingdom
-
theresa.harvey-dunstan@uhl-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13643

Study information

Scientific title

A comprehensive comparison of the sensitivity of common exercise outcome measures for chronic obstructive pulmonary disease (COPD): a randomised trial

Acronym

WP4 Exercise Outcome Study

Study hypothesis

The study aims to conduct a comprehensive comparison of exercise tests commonly used to assess functional capacity in patients with Chronic Obstructive Pulmonary Disease (COPD). Several exercise tests have been described for this purpose, however, there has been no comprehensive comparison of the relative reproducibility and sensitivity of these tests following a standard intervention. The study will help provide a greater understanding of the relative properties (stability and sensitivity) of these tests. The study will provide information for the regulatory bodies regarding the assessment of activity limitation in COPD for future clinical trials.

The study will compare the outcomes of the exercise tests following an effective intervention, of either pulmonary rehabilitation or an inhaled bronchodilator therapy for 6 weeks. There will also be a control arm where there is no intervention. The study aims to recruit approximately 241 patients (phase 1 n=61 and phase 2 n=78) with COPD (COPD Gold 2 – 4). Patients will be in the study for approximately 7 weeks, where the exercise tests will be performed prior and post intervention. The range of change in performance will be measured to enable an evaluation of the exercise tests.

Ethics approval

REC - 12/WM/0306, 22/02/2013

Study design

Randomised interventional 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

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

Intervention

1. Pulmonary Rehabilitation: Six week programme, twice weekly
2. Tiotropium, Exercise test sensitivity to the addition of Tiotropium
3. Control: No intervention

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Vo2 Peak measured at baseline and post Intervention

Secondary outcome measures

Work Load, Duration, Heart Rate, SpO2, Distance, Borg Breathlessness Scale, Strength (kg), Gait Speed, function scores & Health related Quality of Life.

Overall trial start date

01/03/2013

Overall trial end date

30/11/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 25/01/2016:
1. Confirmed diagnosis of COPD (COPD Gold Stage II – Gold IV)
2. MRC grade dyspnoea >2
3. Aged 40 - 85 years, male & female

Previous inclusion criteria:
1. Confirmed diagnosis of COPD (COPD Gold Stage II – Gold IV)
2. MRC grade dyspnoea >3
3. Aged 40 - 85 years, male & female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

139

Participant exclusion criteria

1. Co-morbidity that limits the ability to walk/cycle (e.g. musculoskeletal, arthritic, or neurological disorders)
2. Participation in rehabilitation over the last 12 months
3. Patients on long term oxygen therapy
4. Patients requiring oxygen therapy during the course of an exercise test (i.e. de-saturation documented below 85%)

Recruitment start date

22/03/2013

Recruitment end date

31/08/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Glenfield Hospital
Leicester
LE3 9QP
United Kingdom

Sponsor information

Organisation

Glenfield Hospital (UK)

Sponsor details

Groby Road
Leicester
LE3 9QP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.leicestershospitals.nhs.uk/aboutus/our-hospitals/glenfield-hospital/

Funders

Funder type

Industry

Funder name

GlaxoSmithKline

Alternative name(s)

GlaxoSmithKline plc., GSK

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

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

2014 interim analysis in: http://erj.ersjournals.com/content/44/Suppl_58/P3682.abstract

Publication citations

Additional files

Editorial Notes

17/08/2017: The overall trial end date was changed from 31/08/2017 to 30/11/2017. 20/12/2016: Following a planned revision of the power calculation, the total number of patients to be recruited over the duration of the trial will be 139 (previously 241). These participants will be recruited at a single site. For the second phase of the trial, the final randomisation allocation for all 139 participants will be 1:1:4 (usual care : pulmonary rehabilitation : bronchodilation using LAMA). 08/10/2015: The study was submitted for registration on 22/11/2012 before the recruitment of the first participant. Following this submission, there were no subsequent changes to the information as supplied in the study record. The recruitment started on 22/03/2013, after the trialist applied for registration. 25/01/2015: The overall trial end date was changed from 31/12/2015 to 31/08/2017.