Chronic Obstructive Pulmonary DiseaseNCT01478646
The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) III-IV
A study testing conventional breathing therapy and reflectory breathing therapy in people with Chronic Obstructive Pulmonary Disease, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether different types of breathing therapies in patients with COPD III-IV decrease dyspnea and increase activity. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- conventional breathing therapy and reflectory breathing therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- inpatient rehabilitation
- COPD (Gold stage III and IV)
Who cannot join
- severe exacerbation in the last four weeks
- acute infections
- fever
- neuritides
- severe osteoporosis
- skin disease
- manic depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy on Dyspnoea and Activity in Patients With COPD III-IV
The purpose of this study is to determine whether different types of breathing therapies in patients with COPD III-IV decrease dyspnea and increase activity.
Read the detailed description
In the treatment of COPD-Patients different kinds of breathing therapy techniques are used, but many of them are not reassessed yet.
Dyspnea is one of the predominant symptoms of COPD patients and has negative impacts on the activity of the patients. Dyspnea during exertion leads to avoiding activity and results in a deconditioning of muscles and of the cardiovascular system.
Thus breathing therapy techniques seem to be useful, which may lead to a decrease of dyspnea and an increase of activity.
The purpose of this study is to determine whether reflective breathing therapy is more effective on decreasing dyspnea and increasing activity than conventional breathing therapy.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- conventional breathing therapy, reflectory breathing therapy
- Keywords
- breathing therapy, reflective breathing therapy, COPD, chronic obstructive pulmonary disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional breathing therapyOther
duration: 60 minutes.
reflectory breathing therapyOther
duration: 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Conventional breathing therapy | Experimental | first: conventional breathing therapy, second: reflectory breathing therapy Receives: Other: conventional breathing therapy |
| Reflectory breathing therapy | Experimental | first: reflectory breathing therapy second: conventional breathing therapy Receives: Other: reflectory breathing therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BORG-Scale
Instrument for self-reported dyspnea; modified BORG-scale ranges from 1 (no dyspnea) to 10 (maximum dyspnea).
Measured: Change from pre (minute o) in BORG-scale at directly post intervention (minute 60)
Secondary outcomes (1)
Change in residual volume
measured by a portable spirometry device
Measured: change from pre (minute 0) in residual volume at post (minute 60) intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Collaborators
- University of Osnabrueck
- Responsible party
- Principal investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
- Investigators
- Klaus Kenn, Dr. med., Study chair, Schön Klinik Berchtesgadener LandStella Seeberg, Principal investigator, University of Osnabrueck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478646
- Sponsor's protocol ID
- RAT 2011
- Other IDs
- KBerchtesgadener
- Status last verified
- Nov 2011
- First submitted
- 30 Sep 2011
- Last updated
- 23 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy on Dyspnoea and Activity in Patients With COPD III-IV
- ClinicalTrials.gov ID
- NCT01478646
- Acronym / sponsor ID
- RAT 2011
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- breathing therapy, reflective breathing therapy, COPD, chronic obstructive pulmonary disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Collaborators
- University of Osnabrueck
- Study start
- Aug 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 23 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether different types of breathing therapies in patients with COPD III-IV decrease dyspnea and increase activity.
Detailed description
In the treatment of COPD-Patients different kinds of breathing therapy techniques are used, but many of them are not reassessed yet.
Dyspnea is one of the predominant symptoms of COPD patients and has negative impacts on the activity of the patients. Dyspnea during exertion leads to avoiding activity and results in a deconditioning of muscles and of the cardiovascular system.
Thus breathing therapy techniques seem to be useful, which may lead to a decrease of dyspnea and an increase of activity.
The purpose of this study is to determine whether reflective breathing therapy is more effective on decreasing dyspnea and increasing activity than conventional breathing therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional breathing therapy | Experimental | Other: conventional breathing therapyfirst: conventional breathing therapy, second: reflectory breathing therapy |
| Reflectory breathing therapy | Experimental | Other: reflectory breathing therapyfirst: reflectory breathing therapy second: conventional breathing therapy |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- inpatient rehabilitation
- COPD (Gold stage III and IV)
Key exclusion criteria (7 listed)
- severe exacerbation in the last four weeks
- acute infections
- fever
- neuritides
- severe osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional breathing therapyduration: 60 minutes. | Other | Conventional breathing therapy |
| reflectory breathing therapyduration: 60 minutes. | Other | Reflectory breathing therapy |
Primary outcome
Change in BORG-Scale
Time frame: Change from pre (minute o) in BORG-scale at directly post intervention (minute 60)
Instrument for self-reported dyspnea; modified BORG-scale ranges from 1 (no dyspnea) to 10 (maximum dyspnea).
1 secondary outcome
Change in residual volume
Time frame: change from pre (minute 0) in residual volume at post (minute 60) intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Kenn, Dr. med. study chair
Schön Klinik Berchtesgadener Land
Stella Seeberg principal investigator
University of Osnabrueck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional breathing therapy and reflectory breathing therapy in people with Chronic Obstructive Pulmonary Disease, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BORG-Scale (time frame: Change from pre (minute o) in BORG-scale at directly post intervention (minute 60)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2011.