Back to resultsRehabilitation for Patients With Pulmonary Arterial Hypertension
Primary Purpose
Pulmonary Arterial Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Physical training
No training
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Rehabilitation
Eligibility 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.
Sites / Locations
- Pulmonary Institute, Rabin Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Physical training
No physical training
Outcomes
Primary Outcome Measures
Six minute walking distance
New York Heart Association (NYHA) functional class
Secondary Outcome Measures
Echocardiographic parameters
Quality of life as assessed by the SF-36
Performance in cardiopulmonary exercise test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00544726
Brief Title
Rehabilitation for Patients With Pulmonary Arterial Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Physical training
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
No physical training
Intervention Type
Behavioral
Intervention Name(s)
Physical training
Intervention Type
Behavioral
Intervention Name(s)
No training
Primary Outcome Measure Information:
Title
Six minute walking distance
Time Frame
3 months
Title
New York Heart Association (NYHA) functional class
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Echocardiographic parameters
Time Frame
3 months
Title
Quality of life as assessed by the SF-36
Time Frame
3 months
Title
Performance in cardiopulmonary exercise test
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mordechai R Kramer, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Pulmonary Institute, Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
16982941
Citation
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.
Results Reference
background
PubMed Identifier
16760357
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. doi: 10.1164/rccm.200508-1211ST. No abstract available.
Results Reference
background
PubMed Identifier
21362526
Citation
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.
Results Reference
derived
Learn more about this trial
Rehabilitation for Patients With Pulmonary Arterial Hypertension
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