Prospective Study on Rehabilitation Patients With Pulmonary Hypertension and Other Pulmonary Diseases
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02002351 |
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Recruitment Status :
Completed
First Posted : December 5, 2013
Last Update Posted : March 30, 2016
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Sponsor:
Paracelsus Harz Clinic Bad Suderode.
Collaborator:
Actelion
Information provided by (Responsible Party):
Paracelsus Harz Clinic Bad Suderode.
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date | November 28, 2013 | ||
| First Posted Date | December 5, 2013 | ||
| Last Update Posted Date | March 30, 2016 | ||
| Study Start Date | December 2013 | ||
| Actual Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures |
Data collection [ Time Frame: 12 Months ] Characterization of patients with pulmonary hypertension and other pulmonary diseases in a german rehabilitation clinic.
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| Original Primary Outcome Measures | Same as current | ||
| Change History | |||
| Current Secondary Outcome Measures | Not Provided | ||
| Original Secondary Outcome Measures | Not Provided | ||
| Current Other Pre-specified Outcome Measures | Not Provided | ||
| Original Other Pre-specified Outcome Measures | Not Provided | ||
| Descriptive Information | |||
| Brief Title | Prospective Study on Rehabilitation Patients With Pulmonary Hypertension and Other Pulmonary Diseases | ||
| Official Title | Not Provided | ||
| Brief Summary | 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. | ||
| Detailed Description | Not Provided | ||
| Study Type | Observational [Patient Registry] | ||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 12 Months | ||
| Biospecimen | Not Provided | ||
| Sampling Method | Non-Probability Sample | ||
| Study Population | All rehabilitation patients with pulmonary diseases in the Paracelsus-Harz-Clinic Bad Suderode will be included, starting December 2013,ending Novermber 2014. | ||
| Condition |
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| Intervention | Not Provided | ||
| Study Groups/Cohorts | Pulmonary disease | ||
| Publications * | Not Provided | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status | Completed | ||
| Actual Enrollment |
450 | ||
| Original Estimated Enrollment |
400 | ||
| Actual Study Completion Date | March 2016 | ||
| Actual Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries | Germany | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number | NCT02002351 | ||
| Other Study ID Numbers | ParacelsusHCBS 22/13 | ||
| Has Data Monitoring Committee | No | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement | Not Provided | ||
| Responsible Party | Paracelsus Harz Clinic Bad Suderode. | ||
| Study Sponsor | Paracelsus Harz Clinic Bad Suderode. | ||
| Collaborators | Actelion | ||
| Investigators | Not Provided | ||
| PRS Account | Paracelsus Harz Clinic Bad Suderode. | ||
| Verification Date | January 2015 | ||