Interval exercise versus continuous exercise in patients with moderate to severe chronic obstructive pulmonary disease
| ISRCTN | ISRCTN11611768 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11611768 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/06/2004
- Registration date
- 08/06/2004
- Last edited
- 20/10/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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
Contact information
Scientific
Horten Centre
University of Zurich
Postfach Nord
University Hospital
Zurich
8091
Switzerland
| Phone | +41 1 255 87 09 |
|---|---|
| milo.puhan@evimed.ch |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Interval exercise versus continuous exercise in patients with moderate to severe chronic obstructive pulmonary disease |
| Study objectives | 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(s) | Ethics Committee of the Kantonsspital Aarau, Aargau, Switzerland |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/05/2004 |
| Completion date | 30/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | COPD with Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage III and IV admitted to an inpatient respiratory rehabilitation |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 30/09/2005 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
8091
Switzerland
Sponsor information
Industry
Grafenau 10
Zug
6301
Switzerland
"ROR" |
https://ror.org/034rhks82 |
|---|
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- AstraZeneca PLC, Pearl Therapeutics
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 13/08/2004 | Yes | No | |
| Results article | results | 05/12/2006 | Yes | No |
Editorial Notes
20/10/2016: Plain English summary added.
