Rehabilitation for Patients With Pulmonary Arterial Hypertension

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. Identifier: NCT00544726
Recruitment Status : Unknown
Verified October 2007 by Rabin Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : October 16, 2007
Last Update Posted : April 8, 2008
Information provided by:
Rabin Medical Center

Brief Summary:

Patients suffering from pulmonary arterial hypertension (PAH) frequently remain symptomatic despite medical therapy. Symptoms include breathlessness, poor exercise capacity and reduced quality of life.

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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Behavioral: Physical training Behavioral: No training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2008

Arm Intervention/treatment
Active Comparator: 1
Physical training
Behavioral: Physical training
Placebo Comparator: 2
No physical training
Behavioral: No training

Primary Outcome Measures :
  1. Six minute walking distance [ Time Frame: 3 months ]
  2. New York Heart Association (NYHA) functional class [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Echocardiographic parameters [ Time Frame: 3 months ]
  2. Quality of life as assessed by the SF-36 [ Time Frame: 3 months ]
  3. Performance in cardiopulmonary exercise test [ Time Frame: 3 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients must satisfy current diagnostic criteria for pulmonary artery hypertension based on their historical right heart catheter data (within 4 years of study enrollment): Mean PAP >25mmHg at rest or >30mmHg with exercise, by a PCWP <= 15mmHg and by PVR >3 Wood Units.
  • 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:

  • Functional Class NYHA Class I or IV.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00544726

Pulmonary Institute, Rabin Medical Center
Petach Tikva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
Study Director: Mordechai R Kramer, MD Rabin Medical Center

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00544726     History of Changes
Other Study ID Numbers: rmc074491ctl
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: April 8, 2008
Last Verified: October 2007

Keywords provided by Rabin Medical Center:

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases