NCT01512043

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

May 6, 2014

Status Verified

May 1, 2014

Enrollment Period

2.2 years

First QC Date

December 8, 2011

Last Update Submit

May 5, 2014

Conditions

COPD

Keywords

BreathlessnessSymptomsQuality of life

Outcome Measures

Primary Outcomes (1)

  • Breathlessness

    Questionnaires

    4 months

Secondary Outcomes (9)

  • Depression

    4 months

  • Pulmonary functional tests

    4 months

  • Anxiety

    4 months

  • Fatigue

    4 months

  • Sleeping difficulties

    4 months

  • +4 more secondary outcomes

Study Arms (3)

1. Breathing control

EXPERIMENTAL

Description ...

Behavioral: Breathing control

2. Listening to music

ACTIVE COMPARATOR

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

3. Silence

SHAM COMPARATOR

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

Breathing controlBEHAVIORAL

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

1. Breathing control2. Listening to music3. Silence

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lovisenberg Diakonale Hospital

Oslo, 0440, Norway

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Astrid K Wahl, Professor

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2011

First Posted

January 19, 2012

Study Start

July 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

May 6, 2014

Record last verified: 2014-05

Locations

NO(1)