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Breathing Control in Patients With Chronic Obstructive Pulmonary Disease (COPD)
This study has been completed.
Sponsor:
Lovisenberg Diakonale Hospital
Collaborators:
University of Oslo
Norwegian Foundation for Health and Rehabilitation
University of Bergen
Information provided by (Responsible Party):
Lovisenberg Diakonale Hospital
ClinicalTrials.gov Identifier:
NCT01512043
First received: December 8, 2011
Last updated: May 5, 2014
Last verified: May 2014
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Purpose
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.
| Condition | Intervention |
|---|---|
| COPD | Behavioral: Breathing control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) |
| Official Title: | Breathing Control in Patients With Chronic Obstructive Pulmonary Disease (COPD) Intervention With Device-guided Breathing Control in COPD |
Resource links provided by NLM:
Further study details as provided by Lovisenberg Diakonale Hospital:
Primary Outcome Measures:
- Breathlessness [ Time Frame: 4 months ]Questionnaires
Secondary Outcome Measures:
- Depression [ Time Frame: 4 months ]Questionnaires
- Pulmonary functional tests [ Time Frame: 4 months ]
- Anxiety [ Time Frame: 4 months ]Questionnaires
- Fatigue [ Time Frame: 4 months ]Questionnaire
- Sleeping difficulties [ Time Frame: 4 months ]Questionnaires
- Pain [ Time Frame: 4 months ]Questionnaire
- 6. Min walk test [ Time Frame: 4 months ]
- Arterial blood gas measures [ Time Frame: 4 months ]
- Quality of life [ Time Frame: 4 months ]Questionnaire
| Enrollment: | 150 |
| Study Start Date: | July 2011 |
| Study Completion Date: | September 2013 |
| Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1. Breathing control
Description ...
|
Behavioral: Breathing control
Practice of device guided breathing control twice a day for four weeks.
|
|
Active Comparator: 2. Listening to music
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.
|
Behavioral: Breathing control
Practice of device guided breathing control twice a day for four weeks.
|
|
Sham Comparator: 3. Silence
Using the device to measure breathing movement twice a day for four weeks. No instruction on breathing control and no music.
|
Behavioral: Breathing control
Practice of device guided breathing control twice a day for four weeks.
|
Eligibility| Ages Eligible for Study: | 30 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512043
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512043
Locations
| Norway | |
| Lovisenberg Diakonale Hospital | |
| Oslo, Norway, 0440 | |
Sponsors and Collaborators
Lovisenberg Diakonale Hospital
University of Oslo
Norwegian Foundation for Health and Rehabilitation
University of Bergen
Investigators
| Principal Investigator: | Astrid K Wahl, Professor | University of Oslo |
More Information
| Responsible Party: | Lovisenberg Diakonale Hospital |
| ClinicalTrials.gov Identifier: | NCT01512043 History of Changes |
| Other Study ID Numbers: |
2009/2/0285 |
| Study First Received: | December 8, 2011 |
| Last Updated: | May 5, 2014 |
Keywords provided by Lovisenberg Diakonale Hospital:
|
Breathlessness Symptoms Quality of life |
Additional relevant MeSH terms:
|
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 22, 2017