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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512043
• Other study ID #: 2009/2/0285
• Status: Completed
• Phase: N/A
• First received: December 8, 2011
• Last updated: May 5, 2014
• Start date: July 2011
• Est. completion date: September 2013

Study information

• Verified date: May 2014
• Source: Lovisenberg Diakonale Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Norway	Lovisenberg Diakonale Hospital	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Lovisenberg Diakonale Hospital	Norwegian Foundation for Health and Rehabilitation, University of Bergen, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

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