- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01410279
Inspiratory Muscle Training in Pulmonary Hypertension
August 4, 2011 updated by: Hospital de Clinicas de Porto Alegre
Inspiratory Muscle Training Effect on the Functional Capacity and the Quality of Life in Chronic Pulmonary Hypertension
The purpose of this study is evaluate the effect the inspiratory muscle training on the functional capacity of patients with pulmonary hypertension.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Pulmonary hypertension (PH) is a syndrome, in the case of hemodynamic alteration of a number of diseases and processes, such as the progressive increase in pulmonary vascular resistance, right heart failure and early death.
Frequently patients with PH have reduced functional capacity, quality of life and survival.
It was demonstrated recently that patients with HP also have inspiratory muscle weakness, possibly further increase the fatigue and dyspnea during exercise.
To meet this need, inspiratory muscle training can lead to significant improvement in respiratory muscle strength, exercise tolerance and dyspnea, thus resulting in reduction of discomfort during activities of daily living, increase in exercise capacity and improved quality of life in different situations.
Study Type
Interventional
Enrollment (Anticipated)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pedro Dal'Lago
- Phone Number: 55(51)3303-8796
- Email: pdallago@ufcspa.edu.br
Study Contact Backup
- Name: Glória M Ferreira
- Phone Number: 55(51)9284.0703
- Email: glomenz@yahoo.com.br
Study Locations
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazil, 90035003
- Recruiting
- Hospital de Clínica de Porto Alegre
-
Contact:
- Pedro Dal'Lago
- Phone Number: +55(51)3303-8796
- Email: pdallago@ufcspa.edu.br
-
Contact:
- Glória M Ferreira
- Phone Number: +55(51)9284-0703
- Email: glomenz@yahoo.com.br
-
Principal Investigator:
- Pedro Dal'Lago
-
Sub-Investigator:
- Glória M Ferreira
-
Sub-Investigator:
- Sérgio M Barreto
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis pulmonary hypertension
- World Health Organization (WHO) functional class II to IV
- inspiratory muscle weakness
Exclusion Criteria:
- obesity
- chronic obstructive pulmonary disease
- orthopedic and neurological disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The distance traveled in meters in the six minutes walk test after 8 weeks the inspiratory muscle training
Time Frame: patients will be monitored throughout the training protocol for 8 weeks
|
patients will be monitored throughout the training protocol for 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Increase in score of quality of life questionnaire after 8 weeks the inspiratory muscle training
Time Frame: patients will be monitored throughout the training protocol for 8 weeks
|
patients will be monitored throughout the training protocol for 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Pedro Dal'Lago, Hospital de Clinicas de Porto Alegre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dall'Ago P, Chiappa GR, Guths H, Stein R, Ribeiro JP. Inspiratory muscle training in patients with heart failure and inspiratory muscle weakness: a randomized trial. J Am Coll Cardiol. 2006 Feb 21;47(4):757-63. doi: 10.1016/j.jacc.2005.09.052. Epub 2006 Jan 26.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Anticipated)
September 1, 2011
Study Completion (Anticipated)
December 1, 2011
Study Registration Dates
First Submitted
April 20, 2011
First Submitted That Met QC Criteria
August 4, 2011
First Posted (Estimate)
August 5, 2011
Study Record Updates
Last Update Posted (Estimate)
August 5, 2011
Last Update Submitted That Met QC Criteria
August 4, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09032
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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