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CompletedNCT01512043Updated May 6, 2014

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

An interventional study of Breathing control in COPD, sponsored by Lovisenberg Diakonale Hospital. Completed at 1 site in Norway. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2014-05-06.

Sponsored by Lovisenberg Diakonale Hospital · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
30 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • COPD

Keywords

  • Breathlessness
  • Symptoms
  • Quality of life
03

In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's enrollment of 150 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Lovisenberg Diakonale Hospital is the lead sponsor of 24 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    1. Breathing control

    Description ...

    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.

    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.

    Behavioral: Breathing control

Interventions

  • BehavioralBreathing control

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

06

What researchers measure

Primary outcomes

  1. Breathlessness

    Questionnaires

    Time frame: 4 months

Secondary outcomes

  1. Depression

    Questionnaires

    Time frame: 4 months

  2. Pulmonary functional tests

    Time frame: 4 months

  3. Anxiety

    Questionnaires

    Time frame: 4 months

  4. Fatigue

    Questionnaire

    Time frame: 4 months

  5. Sleeping difficulties

    Questionnaires

    Time frame: 4 months

  6. Pain

    Questionnaire

    Time frame: 4 months

  7. 6. Min walk test

    Time frame: 4 months

  8. Arterial blood gas measures

    Time frame: 4 months

  9. Quality of life

    Questionnaire

    Time frame: 4 months

07

Study locations

1 site
  • Lovisenberg Diakonale Hospital
    Oslo, 0440, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01512043
Lead sponsor
Lovisenberg Diakonale Hospital
Collaborators
University of Oslo, Norwegian Foundation for Health and Rehabilitation, University of Bergen
Responsible party
Sponsor
First posted
Jan 19, 2012
Start date
Jul 2011
Primary completion
Sep 2013
Completion
Sep 2013
Last update
May 6, 2014

Study contacts

Astrid K Wahl, Professor
principal investigator · University of Oslo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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