Inspiratory Muscle Training in Pulmonary Hypertension

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Hospital de Clinicas de Porto Alegre.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Associação Fundo de Incentivo à Pesquisa
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01410279
First received: April 20, 2011
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention
Pulmonary Hypertension
Other: Inspiratory muscle training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inspiratory Muscle Training Effect on the Functional Capacity and the Quality of Life in Chronic Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 34
Study Start Date: December 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Inspiratory muscle training
    The load is adjusted weekly in thirty percent of maximal inspiratory pressure of the subject.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 20, 2011
Last Updated: August 4, 2011
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on September 22, 2014