Breathing Control in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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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.

Official Title
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Breathing Control in Patients With Chronic Obstructive Pulmonary Disease (COPD) Intervention With Device-guided Breathing Control in COPD

Conditions
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COPD

Intervention / Treatment
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* Behavioral: Breathing control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. Breathing control<br>Description ... | Behavioral: Breathing control<br>* Practice of device guided breathing control twice a day for four weeks.<br>|
| Active Comparator: 2. Listening to music<br>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<br>* Practice of device guided breathing control twice a day for four weeks.<br>|
| Sham Comparator: 3. Silence<br>Using the device to measure breathing movement twice a day for four weeks. No instruction on breathing control and no music. | Behavioral: Breathing control<br>* Practice of device guided breathing control twice a day for four weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breathlessness | Questionnaires | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Questionnaires | 4 months | 
| Pulmonary functional tests |  | 4 months | 
| Anxiety | Questionnaires | 4 months | 
| Fatigue | Questionnaire | 4 months | 
| Sleeping difficulties | Questionnaires | 4 months | 
| Pain | Questionnaire | 4 months | 
| 6. Min walk test |  | 4 months | 
| Arterial blood gas measures |  | 4 months | 
| Quality of life | Questionnaire | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breathlessness, Symptoms, Quality of life