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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
COPD	Behavioral: Breathing control	Not Applicable

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	150 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Official Title:	Breathing Control in Patients With Chronic Obstructive Pulmonary Disease (COPD) Intervention With Device-guided Breathing Control in COPD
Study Start Date :	July 2011
Actual Primary Completion Date :	September 2013
Actual Study Completion Date :	September 2013

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Breathlessness [ Time Frame: 4 months ]
   Questionnaires

Secondary Outcome Measures :

1. Depression [ Time Frame: 4 months ]
   Questionnaires
2. Pulmonary functional tests [ Time Frame: 4 months ]
3. Anxiety [ Time Frame: 4 months ]
   Questionnaires
4. Fatigue [ Time Frame: 4 months ]
   Questionnaire
5. Sleeping difficulties [ Time Frame: 4 months ]
   Questionnaires
6. Pain [ Time Frame: 4 months ]
   Questionnaire
7. 6. Min walk test [ Time Frame: 4 months ]
8. Arterial blood gas measures [ Time Frame: 4 months ]
9. Quality of life [ Time Frame: 4 months ]
   Questionnaire

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Lovisenberg Diakonale Hospital
ClinicalTrials.gov Identifier:	NCT01512043 History of Changes
Other Study ID Numbers:	2009/2/0285
First Posted:	January 19, 2012
Last Update Posted:	May 6, 2014
Last Verified:	May 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