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

NCT01512043 — Not applicable, Completed, 150 participants, Lovisenberg Diakonale Hospital

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

Registry	NCT01512043
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double
Enrollment	150 (Actual)
Sponsor	Lovisenberg Diakonale Hospital (Other); collaborators: University of Oslo, Norwegian Foundation for Health and Rehabilitation, University of Bergen
Conditions	COPD
Interventions	Breathing control (Behavioral)
Dates	start 2011-07-01, primary completion 2013-09-01, completion 2013-09-01, first posted 2012-01-19, last updated 2014-05-06
Locations	1 site in Norway

-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. 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.

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+Arms and interventions

Arm	Type	Interventions	Description
1. Breathing control	Experimental	Behavioral: Breathing control	Description ...
2. Listening to music	Active comparator	Behavioral: Breathing control	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.
3. Silence	Sham comparator	Behavioral: Breathing control	Using the device to measure breathing movement twice a day for four weeks. No instruction on breathing control and no music.

Breathing control (Behavioral): Practice of device guided breathing control twice a day for four weeks.

+Outcome measures

Primary outcomes

Breathlessness [4 months]: Questionnaires

Secondary outcomes

Depression [4 months]: Questionnaires
Pulmonary functional tests [4 months]
Anxiety [4 months]: Questionnaires
Fatigue [4 months]: Questionnaire
Sleeping difficulties [4 months]: Questionnaires
Pain [4 months]: Questionnaire
6. Min walk test [4 months]
Arterial blood gas measures [4 months]
Quality of life [4 months]: Questionnaire

+Eligibility

Sex: All, ages: 30 Years to any

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

+Locations (1)

Facility	City	Country	Status
Lovisenberg Diakonale Hospital	Oslo	Norway

+Investigators

Astrid K Wahl, Professor, Principal investigator, University of Oslo