Inspiratory Muscle Training in Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01410279
• Other study ID #: 09032
• Status: Recruiting
• Phase: N/A
• First received: April 20, 2011
• Last updated: August 4, 2011
• Start date: December 2009
• Est. completion date: December 2011

Study information

• Verified date: August 2011
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Pedro Dal'Lago
• Phone: 55(51)3303-8796
• Email: pdallago[@]ufcspa.edu.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension
• Respiratory Aspiration

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital de Clinica de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Associação Fundo de Incentivo à Pesquisa, Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. Epub 2006 Jan 26. — View 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, Grünig E. Exercise and respiratory training improve exercise capacity a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The distance traveled in meters in the six minutes walk test after 8 weeks the inspiratory muscle training		patients will be monitored throughout the training protocol for 8 weeks	No
Secondary	Increase in score of quality of life questionnaire after 8 weeks the inspiratory muscle training		patients will be monitored throughout the training protocol for 8 weeks	No