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Rehabilitation for Patients With Pulmonary Arterial Hypertension

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00544726
First received: October 15, 2007
Last updated: April 6, 2008
Last verified: October 2007
  Purpose

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 Intervention
Pulmonary Arterial Hypertension
Behavioral: Physical training
Behavioral: No training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

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

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

Estimated Enrollment: 45
Study Start Date: February 2008
Arms Assigned Interventions
Active Comparator: 1
Physical training
Behavioral: Physical training
Placebo Comparator: 2
No physical training
Behavioral: No training

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544726

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00544726     History of Changes
Other Study ID Numbers: rmc074491ctl
Study First Received: October 15, 2007
Last Updated: April 6, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Rehabilitation

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

ClinicalTrials.gov processed this record on November 27, 2014