Rehabilitation for Patients With Pulmonary Arterial Hypertension
NCT ID: NCT00544726
Last Updated: 2008-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
45 participants
INTERVENTIONAL
2008-02-29
Brief Summary
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In many other serious heart or lung diseases it has been shown that physical rehabilitation improves patient's fitness and quality of life. In PAH there are no clear guidelines and in general physical activity has traditionally been discouraged, although evidence for this advice is lacking. Interesting research project in Germany showed significant benefit for in-patient rehabilitation in PAH patients.
In this study we will perform a controlled clinical study of out-patient rehabilitation of patients with PAH. We hypothesize that physical training of patients will result in increased exercise capacity and improved quality of life.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Physical training
Physical training
2
No physical training
No training
Interventions
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Physical training
No training
Eligibility Criteria
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Inclusion Criteria
* Willing and able to participate in 24 bi-weekly rehabilitation sessions, and medical follow-up.
* Stable dose of current PAH-specific medication for 3 months prior to enrollment.
* New York Heart Association (NYHA) Class II-III.
* Women of child-bearing age must demonstrate adequate contraception or undergo a pregnancy test.
Exclusion Criteria
* PAH due to congenital heart disease, left heart disease, chronic lung diseases (VC or FEV1 \< 60% of predicted) or chronic hypoxia.
* Acute intercurrent illness requiring hospital admission in the month proceeding screening.
* Any non-PAH medical condition likely to interfere with participation in rehabilitation, e.g. musculoskeletal disorders.
* Any uncontrolled or terminal non-PAH medical condition likely to interfere with completion of the study, according to the judgment of the study physician.
* Participation in another rehabilitation scheme within 6 months of enrollment in the study.
* Current participation in another clinical trial.
* Pregnancy or planned pregnancy during the study period.
18 Years
ALL
No
Sponsors
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Rabin Medical Center
OTHER
Principal Investigators
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Mordechai R Kramer, MD
Role: STUDY_DIRECTOR
Rabin Medical Center
Locations
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Pulmonary Institute, Rabin Medical Center
Petah Tikva, , Israel
Countries
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References
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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.
Nici L, Donner C, Wouters E, Zuwallack R, Ambrosino N, Bourbeau J, Carone M, Celli B, Engelen M, Fahy B, Garvey C, Goldstein R, Gosselink R, Lareau S, MacIntyre N, Maltais F, Morgan M, O'Donnell D, Prefault C, Reardon J, Rochester C, Schols A, Singh S, Troosters T; ATS/ERS Pulmonary Rehabilitation Writing Committee. American Thoracic Society/European Respiratory Society statement on pulmonary rehabilitation. Am J Respir Crit Care Med. 2006 Jun 15;173(12):1390-413. doi: 10.1164/rccm.200508-1211ST. No abstract available.
Fox BD, Kassirer M, Weiss I, Raviv Y, Peled N, Shitrit D, Kramer MR. Ambulatory rehabilitation improves exercise capacity in patients with pulmonary hypertension. J Card Fail. 2011 Mar;17(3):196-200. doi: 10.1016/j.cardfail.2010.10.004. Epub 2010 Dec 3.
Other Identifiers
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rmc074491ctl
Identifier Type: -
Identifier Source: org_study_id