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

NCT ID: NCT01512043

Last Updated: 2014-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-09-30

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.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

1. Breathing control

Description ...

Group Type: EXPERIMENTAL

Breathing control

Intervention Type: BEHAVIORAL

Practice of device guided breathing control twice a day for four weeks.

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.

Group Type: ACTIVE_COMPARATOR

Breathing control

Intervention Type: BEHAVIORAL

Practice of device guided breathing control twice a day for four weeks.

3. Silence

Using the device to measure breathing movement twice a day for four weeks. No instruction on breathing control and no music.

Group Type: SHAM_COMPARATOR

Breathing control

Intervention Type: BEHAVIORAL

Practice of device guided breathing control twice a day for four weeks.

Interventions

Breathing control

Practice of device guided breathing control twice a day for four weeks.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

Norwegian Foundation for Health and Rehabilitation

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: collaborator

Lovisenberg Diakonale Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Astrid K Wahl, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Locations

Lovisenberg Diakonale Hospital

Oslo, , Norway

Countries

Norway

Other Identifiers

2009/2/0285

Identifier Type: -

Identifier Source: org_study_id