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
  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:


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
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

No publications provided

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:
Respiratory Aspiration
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 18, 2014