Chronic Obstructive Pulmonary DiseaseNCT01905982
The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) III-IV; part2
A study testing reflectory breathing therapy and conventional 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, increase activity and have impact on parasympathetic activities. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- reflectory breathing therapy and conventional breathing therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2016to Mar 2020
- 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 50 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.
Germany1 site, 1 recruiting
- Recruiting
Schön Klinik Berchtesgadener Land
Schönau, Bavaria, 83471
Klaus Kenn, Prof., 0049865293 ext. 1540, kkenn@schoen-kliniken.de
Tessa Schneeberger, MSc, 0049865293 ext. 2730, tschneeberger@schoen-kliniken.de
About this study
Official title: The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy on Dyspnoea, Activity and Parasympathetic Activities 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, increase activity and have impact on parasympathetic activities.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- reflectory breathing therapy, conventional breathing therapy
- 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.
reflectory breathing therapyProcedure or surgery
duration:2x60 minutes
conventional breathing therapyProcedure or surgery
duration:4x30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Conventional breathing therapy | Experimental | first: conventional breathing therapy, second: reflectory breathing therapy Receives: Procedure: conventional breathing therapy |
| Reflectory breathing therapy | Experimental | first: Reflectory breathing therapy second:Conventional breathing therapy Receives: Procedure: 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 0) in Borg Scale and directly post intervention
Secondary outcomes (5)
Change in lung volume
measured by a bodyplethysmograph
Measured: change from pre (minute0) in residual volume to post intervention
physical activity
measured by Senswear
Measured: 48 h post intervention
parasympathetic activities
measured via Biofeedback
Measured: baseline and post intervention
Chronic Respiratory Questionnaire
health related quality of life
Measured: baseline and post intervention
COPD Assessment Test
health related Quality of life
Measured: baseline and post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startJan 2016
- Primary completionDec 2019 (estimated)
- Study completionMar 2020 (estimated)
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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
- Investigators
- Klaus Kenn, Prof. Dr., Study chair, Schön Klinik Berchtesgadener LandTessa Schneeberger, Principal investigator, Schön Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905982
- Sponsor's protocol ID
- RAT 2013
- Other IDs
- KBerchtesgadener
- Status last verified
- Jun 2019
- First submitted
- 19 Jul 2013
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. 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, Activity and Parasympathetic Activities in Patients With COPD III-IV
- ClinicalTrials.gov ID
- NCT01905982
- Acronym / sponsor ID
- RAT 2013
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 23 Jul 2013 (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, increase activity and have impact on parasympathetic activities.
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 | Procedure: conventional breathing therapyfirst: conventional breathing therapy, second: reflectory breathing therapy |
| Reflectory breathing therapy | Experimental | Procedure: reflectory breathing therapyfirst: Reflectory breathing therapy second:Conventional breathing therapy |
Who may qualify
- Ages
- 50 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 |
|---|---|---|
| reflectory breathing therapyduration:2x60 minutes | Procedure or surgery | Reflectory breathing therapy |
| conventional breathing therapyduration:4x30 minutes | Procedure or surgery | Conventional breathing therapy |
Primary outcome
Change in BORG-Scale
Time frame: Change from pre (minute 0) in Borg Scale and directly post intervention
Instrument for self-reported dyspnea; modified BORG-scale ranges from 1 (no dyspnea) to 10 (maximum dyspnea)
5 secondary outcomes
Change in lung volume
Time frame: change from pre (minute0) in residual volume to post intervention
physical activity
Time frame: 48 h post intervention
parasympathetic activities
Time frame: baseline and post intervention
Chronic Respiratory Questionnaire
Time frame: baseline and post intervention
COPD Assessment Test
Time frame: baseline and post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
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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, Prof. Dr. study chair
Schön Klinik Berchtesgadener Land
Tessa Schneeberger principal investigator
Schön Klinik Berchtesgadener Land
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reflectory breathing therapy and conventional 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: status not confirmed, as of the sponsor's last update on 18 Jun 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BORG-Scale (time frame: Change from pre (minute 0) in Borg Scale and directly post intervention). 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 18 Jun 2019.