Rehabilitation for Patients With Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00544726
• Other study ID #: rmc074491ctl
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 15, 2007
• Last updated: April 6, 2008
• Start date: February 2008

Study information

• Verified date: October 2007
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 45
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Behavioral:
• Physical training

• No training

Locations

Country	Name	City	State
Israel	Pulmonary Institute, Rabin Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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, Grünig 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. Epub 2006 Sep 18. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six minute walking distance		3 months
Primary	New York Heart Association (NYHA) functional class		3 months
Secondary	Echocardiographic parameters		3 months
Secondary	Quality of life as assessed by the SF-36		3 months
Secondary	Performance in cardiopulmonary exercise test		3 months