COPDNCT01512043
Breathing Control in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A study of COPD, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
Trial summary
There is a demand for explorative and comparative studies on various non-pharmaceutical efforts in treating and helping chronic obstructive pulmonary disease patients. This study has been developed in light of this need. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- COPD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteNorway
- Study dates
- Jul 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dyspnoea symptoms in daily life
- Spirometry values showing a COPD moderate stage II (FEV1/FVC<70%, FEV1<80%) and severity grade at a severe stage III (FEV1/FVC<70%, FEV1<50% and FEV1 = 30% of a predicted)
- Be able to read, write and speak Norwegian
- Be at a stable phase of the disease
Who cannot join
- Changes in pulmonary medication during the last 4 weeks
- Diagnosis of cancer
- Presently attending a pulmonary rehabilitation course or other similar COPD education courses (due to the fact that these courses often have instructions on breathing control), or having attended similar courses during the last six months
- Ongoing exacerbation
- Attending other competitive studies
- Diagnosis of neuromuscular disease
- Diagnosis of dementia
- Attending help from a pulmonary physiotherapist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breathing Control in Patients With Chronic Obstructive Pulmonary Disease (COPD) Intervention With Device-guided Breathing Control in COPD
There is a demand for explorative and comparative studies on various non-pharmaceutical efforts in treating and helping chronic obstructive pulmonary disease patients. This study has been developed in light of this need. The main purpose of the project is to test whether a device guided breathing control system can decreasing the feeling of breathlessness in patients with moderate stage and severe stage of COPD. In addition the study could shed light on whether a reduced feeling of breathlessness can lead to improved physical function, and less experience of other symptoms (I.e., depression, anxiety, sleeping difficulties, fatigue, pain) and provide a better quality of life for patients with COPD.
- Conditions
- COPD
- Being tested
- Breathing control
- Keywords
- Breathlessness, Symptoms, Quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing controlBehavioural
Practice of device guided breathing control twice a day for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1. Breathing control | Experimental | Description ... Receives: Behavioral: Breathing control |
| 2. Listening to music | Active comparator | Listening to music without guiding on breathing on the same device as breathing control twice a day for four weeks. Using the device to measure breathing movements. Receives: Behavioral: Breathing control |
| 3. Silence | Sham comparator | Using the device to measure breathing movement twice a day for four weeks. No instruction on breathing control and no music. Receives: Behavioral: Breathing control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathlessness
Questionnaires
Measured: 4 months
Secondary outcomes (9)
Depression
Questionnaires
Measured: 4 months
Pulmonary functional tests
Measured: 4 months
Anxiety
Questionnaires
Measured: 4 months
Fatigue
Questionnaire
Measured: 4 months
Sleeping difficulties
Questionnaires
Measured: 4 months
Pain
Questionnaire
Measured: 4 months
6. Min walk test
Measured: 4 months
Arterial blood gas measures
Measured: 4 months
Quality of life
Questionnaire
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startJul 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Norwegian Foundation for Health and Rehabilitation, University of Bergen
- Responsible party
- Sponsor
- Investigators
- Astrid K Wahl, Professor, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512043
- Sponsor's protocol ID
- 2009/2/0285
- Status last verified
- May 2014
- First submitted
- 8 Dec 2011
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathing Control in Patients With Chronic Obstructive Pulmonary Disease (COPD) Intervention With Device-guided Breathing Control in COPD
- ClinicalTrials.gov ID
- NCT01512043
- Acronym / sponsor ID
- 2009/2/0285
- Conditions
- COPD
- Keywords
- Breathlessness, Symptoms, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Lovisenberg Diakonale HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, Norwegian Foundation for Health and Rehabilitation, University of Bergen
- Study start
- Jul 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 19 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a demand for explorative and comparative studies on various non-pharmaceutical efforts in treating and helping chronic obstructive pulmonary disease patients. This study has been developed in light of this need. The main purpose of the project is to test whether a device guided breathing control system can decreasing the feeling of breathlessness in patients with moderate stage and severe stage of COPD. In addition the study could shed light on whether a reduced feeling of breathlessness can lead to improved physical function, and less experience of other symptoms (I.e., depression, anxiety, sleeping difficulties, fatigue, pain) and provide a better quality of life for patients with COPD.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. Breathing control | Experimental | Behavioral: Breathing controlDescription ... |
| 2. Listening to music | Active comparator | Behavioral: Breathing controlListening to music without guiding on breathing on the same device as breathing control twice a day for four weeks. Using the device to measure breathing movements. |
| 3. Silence | Sham comparator | Behavioral: Breathing controlUsing the device to measure breathing movement twice a day for four weeks. No instruction on breathing control and no music. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Dyspnoea symptoms in daily life
- Spirometry values showing a COPD moderate stage II (FEV1/FVC<70%, FEV1<80%) and severity grade at a severe stage III (FEV1/FVC<70%, FEV1<50% and FEV1 = 30% of a predicted)
- Be able to read, write and speak Norwegian
- Be at a stable phase of the disease
Key exclusion criteria (8 listed)
- Changes in pulmonary medication during the last 4 weeks
- Diagnosis of cancer
- Presently attending a pulmonary rehabilitation course or other similar COPD education courses (due to the fact that these courses often have instructions on breathing control), or having attended similar courses during the last six months
- Ongoing exacerbation
- Attending other competitive studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing controlPractice of device guided breathing control twice a day for four weeks. | Behavioural | 1. Breathing control, 2. Listening to music, 3. Silence |
Primary outcome
Breathlessness
Time frame: 4 months
Questionnaires
9 secondary outcomes
Depression
Time frame: 4 months
Pulmonary functional tests
Time frame: 4 months
Anxiety
Time frame: 4 months
Fatigue
Time frame: 4 months
Sleeping difficulties
Time frame: 4 months
Pain
Time frame: 4 months
6. Min walk test
Time frame: 4 months
Arterial blood gas measures
Time frame: 4 months
Quality of life
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Astrid K Wahl, Professor principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of COPD, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathlessness (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2014.