Pulmonary DiseasesNCT02002351
Prospective Study on Rehabilitation Patients With Pulmonary Hypertension and Other Pulmonary Diseases
An observational study of Pulmonary Diseases and Rehabilitation, run by Paracelsus Harz Clinic Bad Suderode. at 1 site in Germany.
Trial summary
This monocentric registry should provide information on the extent how patients with pulmonary diseases such as pulmonary hypertension will benefit from rehabilitation treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Diseases, Rehabilitation
- How many people
- 450 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2013to Mar 2016
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All rehabilitation patients with pulmonary diseases in the Paracelsus-Harz-Clinic Bad Suderode will be included, starting December 2013,ending Novermber 2014.
Who may be able to join
- Pulmonary Disease
Who cannot join
- Inability or refusal to give written informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Paracelsus Harz Clinic Bad Suderode
Quedlinburg, Saxony-Anhalt, 06485
About this study
This monocentric registry should provide information on the extent how patients with pulmonary diseases such as pulmonary hypertension will benefit from rehabilitation treatment. The data may provide a basis for further prospective studies showing the treatment of patients with pulmonary diseases especially by physical activation.
- Conditions
- Pulmonary Diseases, Rehabilitation
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data collection
Characterization of patients with pulmonary hypertension and other pulmonary diseases in a german rehabilitation clinic.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Paracelsus Harz Clinic Bad Suderode.
- Sponsor type
- University, hospital or other
- Collaborators
- Actelion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002351
- Sponsor's protocol ID
- ParacelsusHCBS 22/13
- Status last verified
- Jan 2015
- First submitted
- 28 Nov 2013
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Rehabilitation Patients With Pulmonary Hypertension and Other Pulmonary Diseases
- ClinicalTrials.gov ID
- NCT02002351
- Acronym / sponsor ID
- ParacelsusHCBS 22/13
- Conditions
- Pulmonary Diseases, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Paracelsus Harz Clinic Bad Suderode.University, hospital or other
- Collaborators
- Actelion
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 Dec 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.
This monocentric registry should provide information on the extent how patients with pulmonary diseases such as pulmonary hypertension will benefit from rehabilitation treatment. The data may provide a basis for further prospective studies showing the treatment of patients with pulmonary diseases especially by physical activation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary disease | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All rehabilitation patients with pulmonary diseases in the Paracelsus-Harz-Clinic Bad Suderode will be included, starting December 2013,ending Novermber 2014.
Key inclusion criteria (1 listed)
- Pulmonary Disease
Key exclusion criteria (1 listed)
- Inability or refusal to give written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Data collection
Time frame: 12 Months
Characterization of patients with pulmonary hypertension and other pulmonary diseases in a german rehabilitation clinic.
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 30 Mar 2016.
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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?
An observational study of Pulmonary Diseases and Rehabilitation, run by Paracelsus Harz Clinic Bad Suderode. 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 1 inclusion and 1 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 30 Mar 2016. 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?
Data collection (time frame: 12 Months). 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 30 Mar 2016.