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Inspiratory Muscle Training in Pulmonary Hypertension

Primary Purpose

Pulmonary Hypertension

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Inspiratory muscle training

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring pulmonary hypertension, inspiratory muscle training, inspiratory muscle weakness, pulmonary functional, functional capacity, quality of life

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital de Clinica de Porto AlegreRecruiting

Outcomes

Primary Outcome Measures

The distance traveled in meters in the six minutes walk test after 8 weeks the inspiratory muscle training

Secondary Outcome Measures

Increase in score of quality of life questionnaire after 8 weeks the inspiratory muscle training

Full Information

NCT ID

NCT01410279

First Posted

April 20, 2011

Last Updated

August 4, 2011

Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Associação Fundo de Incentivo à Pesquisa, Conselho Nacional de Desenvolvimento Científico e Tecnológico

1. Study Identification

Unique Protocol Identification Number

NCT01410279

Brief Title

Inspiratory Muscle Training in Pulmonary Hypertension

Official Title

Inspiratory Muscle Training Effect on the Functional Capacity and the Quality of Life in Chronic Pulmonary Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Unknown status

Study Start Date

December 2009 (undefined)

Primary Completion Date

September 2011 (Anticipated)

Study Completion Date

December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Associação Fundo de Incentivo à Pesquisa, Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Hypertension

Keywords

pulmonary hypertension, inspiratory muscle training, inspiratory muscle weakness, pulmonary functional, functional capacity, quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

34 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Other

Intervention Name(s)

Inspiratory muscle training

Intervention Description

The load is adjusted weekly in thirty percent of maximal inspiratory pressure of the subject.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pedro Dal'Lago

Phone

55(51)3303-8796

pdallago@ufcspa.edu.br

First Name & Middle Initial & Last Name or Official Title & Degree

Glória M Ferreira

Phone

55(51)9284.0703

glomenz@yahoo.com.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pedro Dal'Lago

Organizational Affiliation

Hospital de Clínicas de Porto Alegre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital de Clinica de Porto Alegre

City

Porto Alegre

State/Province

Rio Grande do Sul

ZIP/Postal Code

90035003

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pedro Dal'Lago

Phone

+55(51)3303-8796

pdallago@ufcspa.edu.br

First Name & Middle Initial & Last Name & Degree

Glória M Ferreira

Phone

+55(51)9284-0703

glomenz@yahoo.com.br

First Name & Middle Initial & Last Name & Degree

Pedro Dal'Lago

First Name & Middle Initial & Last Name & Degree

Glória M Ferreira

First Name & Middle Initial & Last Name & Degree

Sérgio M Barreto

12. IPD Sharing Statement

Citations:

PubMed Identifier

16487841

Citation

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.

Results Reference

result

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

result

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Inspiratory Muscle Training in Pulmonary Hypertension

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