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

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

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Behavioral: Breathing control

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0440
    • Lovisenberg Diakonale Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lovisenberg Diakonale Hospital
• Collaborators: University of Oslo; University of Bergen; Norwegian Foundation for Health and Rehabilitation
• Investigators: Principal Investigator: Astrid K Wahl, Professor, University of Oslo

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: December 8, 2011
• First Submitted That Met QC Criteria: January 13, 2012
• First Posted (Estimate): January 19, 2012

Study Record Updates

• Last Update Posted (Estimate): May 6, 2014
• Last Update Submitted That Met QC Criteria: May 5, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Quality of life; Breathlessness; Symptoms
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2009/2/0285