Chronic Obstructive Pulmonary DiseaseNCT01418768
Effects of an Inpatient Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD) III/IV
A study testing inpatient rehabiliation 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 if there is a change in the CAT-score after an inpatient rehabilitation of three weeks and if it correlates with other common parameters. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- inpatient rehabiliation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Dec 2012
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- inpatient rehabilitation in Schön Klinik Berchtesgadener Land
- stable COPD(GOLD severity III and IV with and without respiratory insufficiency)
Who cannot join
- severe exacerbation in the last four weeks
- acute coronary syndrome
- unability to cooperate
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if there is a change in the CAT-score after an inpatient rehabilitation of three weeks and if it correlates with other common parameters.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- inpatient rehabiliation
- Keywords
- COPD, CAT, Rehabilitation, chronic obstructive pulmonary disease GOLD III/IV
- 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.
inpatient rehabiliationOther
inpatient, multimodal, individual workout including endurance training, strength training, coordination training etc. for three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation | Experimental | Not described Receives: Other: inpatient rehabiliation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CAT-score
Measured: day 1 to day 21
Secondary outcomes (9)
Change in 6 minutes walking distance
Measured: day 1 to day 21
Change in Short-Form 36
Measured: day 1 to day 21
Change in Hospital Anxiety and Depression Scale
Measured: day 1 to day 21
Change in diffusing capacity
Measured: day 1 to day 21
Change in forced expiratory volume in 1 second (FEV1)
Measured: day 1 to day 21
Change in Body Mass index
Measured: day 1 to day 21
Change in basal energy rate
Measured: day 1 to day 21
Change in BODE-Index
Measured: day 1 to day 21
Change in St. George's Respiratory Questionaire
Measured: Day 1 to day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2012
- Study completionDec 2012
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418768
- Sponsor's protocol ID
- CAT2011
- Status last verified
- Feb 2013
- First submitted
- 9 Aug 2011
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Inpatient Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD) III/IV
- ClinicalTrials.gov ID
- NCT01418768
- Acronym / sponsor ID
- CAT2011
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, CAT, Rehabilitation, chronic obstructive pulmonary disease GOLD III/IV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Aug 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 if there is a change in the CAT-score after an inpatient rehabilitation of three weeks and if it correlates with other common parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation | Experimental | Other: inpatient rehabiliation |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- inpatient rehabilitation in Schön Klinik Berchtesgadener Land
- stable COPD(GOLD severity III and IV with and without respiratory insufficiency)
Key exclusion criteria (3 listed)
- severe exacerbation in the last four weeks
- acute coronary syndrome
- unability to cooperate
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 |
|---|---|---|
| inpatient rehabiliationinpatient, multimodal, individual workout including endurance training, strength training, coordination training etc. for three weeks. | Other | Rehabilitation |
Primary outcome
Change in CAT-score
Time frame: day 1 to day 21
9 secondary outcomes
Change in 6 minutes walking distance
Time frame: day 1 to day 21
Change in Short-Form 36
Time frame: day 1 to day 21
Change in Hospital Anxiety and Depression Scale
Time frame: day 1 to day 21
Change in diffusing capacity
Time frame: day 1 to day 21
Change in forced expiratory volume in 1 second (FEV1)
Time frame: day 1 to day 21
Change in Body Mass index
Time frame: day 1 to day 21
Change in basal energy rate
Time frame: day 1 to day 21
Change in BODE-Index
Time frame: day 1 to day 21
Change in St. George's Respiratory Questionaire
Time frame: Day 1 to day 21
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 4 Feb 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inpatient rehabiliation 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 3 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 4 Feb 2013. 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 CAT-score (time frame: day 1 to day 21). 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 4 Feb 2013.