We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Inspiratory Muscle Training in Pulmonary Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01410279
Recruitment Status : Unknown
Verified August 2011 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : August 5, 2011
Last Update Posted : August 5, 2011
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is evaluate the effect the inspiratory muscle training on the functional capacity of patients with pulmonary hypertension.

Condition or disease Intervention/treatment
Pulmonary Hypertension Other: Inspiratory muscle training

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inspiratory Muscle Training Effect on the Functional Capacity and the Quality of Life in Chronic Pulmonary Hypertension
Study Start Date : December 2009
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Other: Inspiratory muscle training
    The load is adjusted weekly in thirty percent of maximal inspiratory pressure of the subject.

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410279


Contacts
Contact: Pedro Dal'Lago 55(51)3303-8796 pdallago@ufcspa.edu.br
Contact: Glória M Ferreira 55(51)9284.0703 glomenz@yahoo.com.br

Locations
Brazil
Hospital de Clinica de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035003
Contact: Pedro Dal'Lago    +55(51)3303-8796    pdallago@ufcspa.edu.br   
Contact: Glória M Ferreira    +55(51)9284-0703    glomenz@yahoo.com.br   
Principal Investigator: Pedro Dal'Lago         
Sub-Investigator: Glória M Ferreira         
Sub-Investigator: Sérgio M Barreto         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Associação Fundo de Incentivo à Pesquisa
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Pedro Dal'Lago Hospital de Clínicas de Porto Alegre
More Information

Publications:
Responsible Party: Pedro Dal'Lago, UFCSPA
ClinicalTrials.gov Identifier: NCT01410279     History of Changes
Other Study ID Numbers: 09032
First Posted: August 5, 2011    Key Record Dates
Last Update Posted: August 5, 2011
Last Verified: August 2011

Keywords provided by Hospital de Clinicas de Porto Alegre:
pulmonary hypertension
inspiratory muscle training
inspiratory muscle weakness
pulmonary functional
functional capacity
quality of life

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Respiratory Aspiration
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes