Rehabilitation for Patients With Pulmonary Arterial Hypertension

NCT00544726 | Unknown

• 1 other identifier: rmc074491ctl
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Six minute walking distance

  3 months

• New York Heart Association (NYHA) functional class

  3 months

Secondary Outcomes (3)

• Echocardiographic parameters

  3 months

• Quality of life as assessed by the SF-36

  3 months

• Performance in cardiopulmonary exercise test

  3 months

Study Arms (2)

1

ACTIVE COMPARATOR

Physical training

Behavioral: Physical training

2

PLACEBO COMPARATOR

No physical training

Behavioral: No training

Interventions

Physical training BEHAVIORAL

1

No training BEHAVIORAL

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Pulmonary Institute, Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Related Publications (3)

• 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.

  PMID: 16982941 BACKGROUND

• 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.

  PMID: 16760357 BACKGROUND

• 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.

  PMID: 21362526 DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mordechai R Kramer, MD

  Rabin Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 15, 2007
• First Posted: October 16, 2007
• Study Start: February 1, 2008
• Last Updated: April 8, 2008

Record last verified: 2007-10

Locations

IL (1)