Condition category
Respiratory
Date applied
08/06/2004
Date assigned
08/06/2004
Last edited
20/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chronic obstructive pulmonary disease is a disease of the lungs that is usually caused by smoking. In COPD, lung damage gradually worsens over time. People with COPD are short of breath and sometimes cough and wheeze. Symptoms slowly get worse over time, but most patients also have intermittent bouts of worsening of symptoms. Lung infections, cold weather, and exertion may bring on these bouts. In addition to medications, the treatment guidelines recommend high-intensity, continuous exercise to improve lung function. However, this type of exercise can be difficult for people with COPD to tolerate. Some believe that short intervals of exercise may also benefit patients with COPD and may be easier for them to accomplish. The aim of this study is to find out whether interval exercise produces the same benefits for people with COPD and is easier for them to tolerate than continuous exercise.

Who can participate?
Adult patients with COPD

What does the study involve?
Participants are randomly allocated to attend 12 to 15 supervised sessions of either continuous or intermittent high-intensity exercise over 3 weeks followed by unsupervised exercise at home. Participants used exercise bikes during the supervised exercise sessions. Participants allocated to continuous exercise warmed up for 2 minutes, pedaled at high intensity for 20 minutes (or until they needed to stop because of fatigue or other symptoms), and cooled down for 2 minutes. Participants in the intermittent exercise group warmed up for 2 minutes, pedaled for 20 minutes, alternating between 20 seconds at high intensity and 40 seconds at low intensity (or until they needed to stop because of fatigue or other symptoms), and cooled down for 2 minutes. Participants completed a standard questionnaire to assess their lung function at the start of the study and 5 weeks into the study. The researchers also collected information on the number of times participants had to take unplanned breaks during the supervised exercise sessions.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
AstraZeneca (Switzerland)

When is the study starting and how long is it expected to run for?
May 2004 to September 2005

Who is funding the study?
1. AstraZeneca (Switzerland)
2. The Helmut Horten Foundation

Who is the main contact?
Dr Milo Puhan
milo.puhan@evimed.ch

Trial website

Contact information

Type

Scientific

Primary contact

Dr Milo Puhan

ORCID ID

Contact details

Horten Centre
University of Zurich
Postfach Nord
University Hospital
Zurich
8091
Switzerland
+41 1 255 87 09
milo.puhan@evimed.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Interval exercise versus continuous exercise in patients with moderate to severe chronic obstructive pulmonary disease

Acronym

Study hypothesis

The aim of this study is to assess if interval exercise compared to high intensity continuous exercise is not of inferior effectiveness in terms of health-related quality of life (HRQL) and exercise capacity improvements but associated with better exercise tolerance in patients with moderate to severe COPD at the beginning of a respiratory rehabilitation.

Ethics approval

Ethics Committee of the Kantonsspital Aarau, Aargau, Switzerland

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Chronic obstructive pulmonary disease (COPD)

Intervention

Group 1: 12-15 sessions of high intensity continuous exercise
Group 2: 12-15 sessions of interval exercise
Between group comparisons in terms of changes of clinical outcomes (health-related quality of life, functional exercise capacity and subjective patient experience of exercise) and physiological outcomes (exercise tests with gas exchange and ventilatory variables) during respiratory rehabilitation.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Health-related quality of life (HRQL), measured by the Chronic Respiratory Questionnaire (CRQ) two weeks after the end of rehabilitation

Secondary outcome measures

Secondary endpoints include additional clinical outcomes such as functional exercise capacity, other HRQL measures, patients' experience of physical exercise as well as physiological measures of the effects of physical exercise such as cardiopulmonary exercise testing.

Overall trial start date

01/05/2004

Overall trial end date

30/09/2005

Reason abandoned

Eligibility

Participant inclusion criteria

COPD with Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage III and IV admitted to an inpatient respiratory rehabilitation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/2004

Recruitment end date

30/09/2005

Locations

Countries of recruitment

Switzerland

Trial participating centre

University of Zurich
Zurich
8091
Switzerland

Sponsor information

Organisation

AstraZeneca Switzerland

Sponsor details

Grafenau 10
Zug
6301
Switzerland

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

AstraZeneca

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Funder name

Helmut Horten Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2004 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/15310394
2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/17146066

Publication citations

  1. Results

    Puhan MA, Büsching G, Schünemann HJ, VanOort E, Zaugg C, Frey M, Interval versus continuous high-intensity exercise in chronic obstructive pulmonary disease: a randomized trial., Ann. Intern. Med., 2006, 145, 11, 816-825.

  2. Puhan MA, Büsching G, VanOort E, Zaugg C, Schünemann HJ, Frey M, Interval exercise versus continuous exercise in patients with moderate to severe chronic obstructive pulmonary disease--study protocol for a randomised controlled trial [ISRCTN11611768]., BMC Pulm Med, 2004, 4, 5, doi: 10.1186/1471-2466-4-5.

Additional files

Editorial Notes

20/10/2016: Plain English summary added.