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

This study has been completed.

Sponsor:

Collaborators:

University of Oslo

Norwegian Foundation for Health and Rehabilitation

University of Bergen

Information provided by (Responsible Party):

Lovisenberg Diakonale Hospital

ClinicalTrials.gov Identifier:

NCT01512043

First received: December 8, 2011

Last updated: May 5, 2014

Last verified: May 2014

History of Changes

Purpose

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	Intervention
COPD	Behavioral: Breathing control


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator)
Official Title:	Breathing Control in Patients With Chronic Obstructive Pulmonary Disease (COPD) Intervention With Device-guided Breathing Control in COPD

Resource links provided by NLM:

MedlinePlus related topics: COPD Lung Diseases

U.S. FDA Resources

Further study details as provided by Lovisenberg Diakonale Hospital:

Primary Outcome Measures:

Breathlessness [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Questionnaires

Secondary Outcome Measures:

Depression [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Questionnaires
Pulmonary functional tests [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Anxiety [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Questionnaires
Fatigue [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Questionnaire
Sleeping difficulties [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Questionnaires
Pain [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Questionnaire
6. Min walk test [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Arterial blood gas measures [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Questionnaire


Enrollment:	150
Study Start Date:	July 2011
Study Completion Date:	September 2013
Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	30 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512043

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


Responsible Party:	Lovisenberg Diakonale Hospital
ClinicalTrials.gov Identifier:	NCT01512043 History of Changes
Other Study ID Numbers:	2009/2/0285
Study First Received:	December 8, 2011
Last Updated:	May 5, 2014
Health Authority:	Norway: Regional Ethics Commitee

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

ClinicalTrials.gov processed this record on September 23, 2016

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