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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

December 8, 2011
May 5, 2014
July 2011
September 2013   (final data collection date for primary outcome measure)
Breathlessness [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Questionnaires
Same as current
Complete list of historical versions of study NCT01512043 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
COPD
Behavioral: Breathing control
Practice of device guided breathing control twice a day for four weeks.
  • Experimental: 1. Breathing control
    Description ...
    Intervention: Behavioral: Breathing control
  • 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.
    Intervention: Behavioral: Breathing control
  • 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.
    Intervention: Behavioral: Breathing control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01512043
2009/2/0285
Yes
Lovisenberg Diakonale Hospital
Lovisenberg Diakonale Hospital
  • University of Oslo
  • Norwegian Foundation for Health and Rehabilitation
  • University of Bergen
Principal Investigator: Astrid K Wahl, Professor University of Oslo
Lovisenberg Diakonale Hospital
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP