Clinical trial NCT01410279: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: pulmonary hypertension
inspiratory muscle training
inspiratory muscle weakness
pulmonary functional
functional capacity
quality of life
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Associação Fundo de Incentivo à Pesquisa
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2011-08-05
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The distance traveled in meters in the six minutes walk test after 8 weeks the inspiratory muscle training
timeFrame: patients will be monitored throughout the training protocol for 8 weeks
Secondary outcomes:
measure: Increase in score of quality of life questionnaire after 8 weeks the inspiratory muscle training
timeFrame: patients will be monitored throughout the training protocol for 8 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinica de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Pedro Dal'Lago
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.