COPD Clinical Trial
Official title:
Breathing Control in Patients With Chronic Obstructive Pulmonary Disease (COPD) Intervention With Device-guided Breathing Control in COPD
Verified date | May 2014 |
Source | Lovisenberg Diakonale Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Norway: Regional Ethics Commitee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
Country | Name | City | State |
---|---|---|---|
Norway | Lovisenberg Diakonale Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Lovisenberg Diakonale Hospital | Norwegian Foundation for Health and Rehabilitation, University of Bergen, University of Oslo |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Breathlessness | Questionnaires | 4 months | No |
Secondary | Depression | Questionnaires | 4 months | No |
Secondary | Pulmonary functional tests | 4 months | No | |
Secondary | Anxiety | Questionnaires | 4 months | No |
Secondary | Fatigue | Questionnaire | 4 months | No |
Secondary | Sleeping difficulties | Questionnaires | 4 months | Yes |
Secondary | Pain | Questionnaire | 4 months | No |
Secondary | 6. Min walk test | 4 months | No | |
Secondary | Arterial blood gas measures | 4 months | No | |
Secondary | Quality of life | Questionnaire | 4 months | No |
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