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Clinical Trials/NCT01512043
NCT01512043CompletedNot Applicable

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

Lovisenberg Diakonale Hospital2 sites in 1 country150 target enrollmentStarted: July 1, 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
150
Locations
2
Primary Endpoint
Breathlessness

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
30 Years to — (Adult, Older Adult)
Sex
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

  • 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

Outcomes

Primary Outcomes

Breathlessness

Time Frame: 4 months

Questionnaires

Secondary Outcomes

  • Depression(4 months)
  • Quality of life(4 months)
  • Pulmonary functional tests(4 months)
  • Fatigue(4 months)
  • Sleeping difficulties(4 months)
  • Pain(4 months)
  • Anxiety(4 months)
  • 6. Min walk test(4 months)
  • Arterial blood gas measures(4 months)

Investigators

Sponsor
Lovisenberg Diakonale Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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