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OpenTrials
Completed

NCT Number: NCT01512043

Breathing Control in Patients With Chronic Obstructive Pulmonary Disease (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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Dyspnea Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lovisenberg Diakonale Hospital

Oslo, 0440, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breathing Control

Behavioral

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

Primary outcomes

  1. Breathlessness

    Time frame: 4 months

    Questionnaires

Secondary outcomes

  1. Depression

    Time frame: 4 months

    Questionnaires

  2. Pulmonary functional tests

    Time frame: 4 months

  3. Anxiety

    Time frame: 4 months

    Questionnaires

  4. Fatigue

    Time frame: 4 months

    Questionnaire

  5. Sleeping difficulties

    Time frame: 4 months

    Questionnaires

  6. Pain

    Time frame: 4 months

    Questionnaire

  7. 6. Min walk test

    Time frame: 4 months

  8. Arterial blood gas measures

    Time frame: 4 months

  9. Quality of life

    Time frame: 4 months

    Questionnaire

Sponsors and collaborators

Lead sponsor

Lovisenberg Diakonale Hospital

Other

Collaborators

  • Norwegian Foundation for Health and Rehabilitation
  • University of Bergen
  • University of Oslo

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 19, 2012
Registry last updated
May 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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