Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-27 @ 12:22 AM
Study NCT ID:
NCT01650857
Status:
UNKNOWN
Last Update Posted:
2015-08-20
First Post:
2012-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Hypertension: Efficacy of a 3 Week Inpatient Rehabilitation on Physical Condition, Body Composition and Health Related Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-19', 'studyFirstSubmitDate': '2012-07-21', 'studyFirstSubmitQcDate': '2012-07-24', 'lastUpdatePostDateStruct': {'date': '2015-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health related Quality of Life', 'timeFrame': '3 weeks', 'description': 'Health related Quality of Life (Short form 36 questionnaire)'}, {'measure': 'Right ventricular function', 'timeFrame': '3 weeks', 'description': 'Right ventricular function (echocardiography: estimated right ventricular systolic pressure, Tricuspid annular plane systolic excursion, left ventricular eccentricity index)'}, {'measure': 'Activities of daily living', 'timeFrame': '3 weeks', 'description': "Activities of daily living (Barthel's Index)"}], 'primaryOutcomes': [{'measure': 'Exercise capacity', 'timeFrame': '3 weeks', 'description': 'Exercise capacity (peak work load and 6-minute walk distance at completion of an 3-week inpatient pulmonary rehabilitation)'}], 'secondaryOutcomes': [{'measure': 'Body composition', 'timeFrame': '3 weeks', 'description': 'Body composition (bioimpedance analysis)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pulmonary hypertension', 'Rehabilitation', 'Exercise capacity', 'Body composition', 'Health related Quality of Life'], 'conditions': ['Pulmonary Hypertension: Efficacy of Rehabilitation']}, 'referencesModule': {'references': [{'pmid': '22221968', 'type': 'BACKGROUND', 'citation': 'Rosenkranz S, Ghofrani HA, Grunig E, Hoeper MM. Cologne Consensus Conference on pulmonary hypertension. Int J Cardiol. 2011 Dec;154 Suppl 1:S1-2. doi: 10.1016/S0167-5273(11)70487-9. No abstract available.'}, {'pmid': '19749199', 'type': 'BACKGROUND', 'citation': 'Task Force for Diagnosis and Treatment of Pulmonary Hypertension of European Society of Cardiology (ESC); European Respiratory Society (ERS); International Society of Heart and Lung Transplantation (ISHLT); Galie N, Hoeper MM, Humbert M, Torbicki A, Vachiery JL, Barbera JA, Beghetti M, Corris P, Gaine S, Gibbs JS, Gomez-Sanchez MA, Jondeau G, Klepetko W, Opitz C, Peacock A, Rubin L, Zellweger M, Simonneau G. Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Respir J. 2009 Dec;34(6):1219-63. doi: 10.1183/09031936.00139009. Epub 2009 Sep 12. No abstract available.'}, {'pmid': '16982941', 'type': 'BACKGROUND', 'citation': 'Mereles D, Ehlken N, Kreuscher S, Ghofrani S, Hoeper MM, Halank M, Meyer FJ, Karger G, Buss J, Juenger J, Holzapfel N, Opitz C, Winkler J, Herth FF, Wilkens H, Katus HA, Olschewski H, Grunig E. Exercise and respiratory training improve exercise capacity and quality of life in patients with severe chronic pulmonary hypertension. Circulation. 2006 Oct 3;114(14):1482-9. doi: 10.1161/CIRCULATIONAHA.106.618397. Epub 2006 Sep 18.'}]}, 'descriptionModule': {'briefSummary': 'Pulmonary hypertension (PH) leads to impaired physical condition (PC), body composition (BC) and health-related quality of life (HRQOL). We hypothesized that a 3 week inpatient pulmonary rehabilitation (PR) improves PC, BC and HRQOL.', 'detailedDescription': 'Pulmonary hypertension (PH) impairs physical condition (PC), body composition (BC) and health-related quality of life (HRQOL).\n\nSpecific pharmacological treatment and - in selected patients, refractory to agents - lung or combined heart and lung transplantation can improve physical functioning and long term survival. Initial trials with limited numbers of patients were encouraging. Investigation of larger cohorts is essential to assess the efficacy of rehabilitation programmes in PH.\n\nWe hypothesize that a 3 week inpatient pulmonary rehabilitation (PR) improves PC, BC and HRQOL in patients with PH in functional classes (FC) II and III. Critical ill patients with a functional class IV are excluded. All patients with PH undergo a 3-week inpatient rehabilitation program (interval bicycle and strength training, physiotherapy, psychological support, education). Exercise testing (peak work load (PWL) 6-min-walk distance), body composition (bioimpedance analysis BIA: lean body mass (LBM), body cell mass (BCM), BCM/LBM ratio, phase angle (PA)) and HRQOL (SF 36 questionnaire) are assessed at baseline and completion of PR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with pulmonary hypertension in World Heart Organization functional classification classes (FC) II and III', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of pulmonary hypertension\n* Functional class II-III\n\nExclusion Criteria:\n\n* Functional class I and IV\n* Right heart decompensation'}, 'identificationModule': {'nctId': 'NCT01650857', 'briefTitle': 'Pulmonary Hypertension: Efficacy of a 3 Week Inpatient Rehabilitation on Physical Condition, Body Composition and Health Related Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'Pulmonary Hypertension: Efficacy of a 3 Week Inpatient Pulmonary Rehabilitation on Physical Condition, Body Composition and Health Related Quality of Life - an Observational Study', 'orgStudyIdInfo': {'id': 'HannoverMS PH-Reha001'}}, 'contactsLocationsModule': {'locations': [{'zip': '29683', 'city': 'Bad Fallingbostel', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Martin G Dierich, MD', 'role': 'CONTACT', 'email': 'dierich@klinik-fallingbostel.de', 'phone': '+49 5162 44 754'}, {'name': 'Martin G Dierich, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinik Bad Fallingbostel', 'geoPoint': {'lat': 52.86641, 'lon': 9.69558}}], 'centralContacts': [{'name': 'Martin G Dierich, MD', 'role': 'CONTACT', 'email': 'dierich.martin@mh-hannover.de', 'phone': '+49 532 3530'}, {'name': 'Thomas Fuehner, MD', 'role': 'CONTACT', 'email': 'fuehner.thomas@mh-hannover.de', 'phone': '+ 49 532 3530'}], 'overallOfficials': [{'name': 'Martin G Dierich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Respiratory Diseases, Hannover Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Klinik Bad Fallingbostel', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Martin G Dierich, MD', 'investigatorAffiliation': 'Hannover Medical School'}}}}