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Plain English Summary

Background & 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 will be looking 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 will be comparing 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, with the results of the study being able to guide further clinical trials and clinical practice.

Who can participate?
People with a diagnosis of COPD and who walk slower due to breathlessness, or have to stop for breath when walking at own pace. Anyone suffering from multiple health issues may be unsuitable to participate as are persons using oxygen therapy.

What does the study involve?
We have chosen to test 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. There is a day of consent & familiarisation followed by 2 baseline tests two weeks later. Patients are then 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: inhaled medication
Group 2: pulmonary rehabilitation
Group3: no intervention (control group)
Patients will also be asked to wear an activity monitor twice; at the start and end of the trial for a period of 7 days.

What are the possible benefits and risks of participating?
The effects and discomforts of each individual test are described in a patient information sheet. Some of the visits are fairly long (maximum 6 hours) but there are breaks in between exercise tests. There are no direct benefits for participating in this research. However, by taking part in this research, people will be contributing to the development and understanding of exercise testing in COPD. If patients are randomised to the rehabilitation group they may feel a benefit from the exercise programme. For those patients who are not randomised 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. Some of the visits are fairly long (maximum 6 hours) but there are breaks in between exercise tests. 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 you have collapsed previously when exercising we will not ask you to participate. You may been 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?
The study is being conducted at the Glenfield Hospital in Leicester as a single site until interim analysis is complete.

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 MSc MCSP

Trial website

Contact information



Primary contact

Ms Theresa Harvey-Dunstan


Contact details

Groby Road
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A Comprehensive Comparison of the Sensitivity of Common Exercise Outcome Measures for Chronic Obstructive Pulmonary Disease (COPD): a randomised trial


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=180) 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.

Further details can be found at:

Ethics approval

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

Study design

Randomised interventional trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


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


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

Intervention type



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


Overall trial end date


Reason abandoned


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


Age group




Target number of participants

241 patients (phase 1 n=61 and phase 2 n=180)

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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Glenfield Hospital
United Kingdom

Sponsor information


Glenfield Hospital (UK)

Sponsor details

Groby Road
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name


Alternative name(s)

GlaxoSmithKline Plc., GSK

Funding Body Type

private sector organisation

Funding Body Subtype



United Kingdom

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 interim analysis in:

Publication citations

Additional files

Editorial Notes

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. On 25/01/2015 the overall trial end date was changed from 31/12/2015 to 31/08/2017.