Effects of Training in Pulmonary Hypertension

Respiratory Muscle Strength Clinical Trial

Official title:

Effects of Respiratory Muscle Training on Respiratory Muscle Strength, Functional Capacity and Quality of Life in Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03186092
• Other study ID #: 64139317.5.0000.5479
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 10, 2020

Study information

• Verified date: November 2019
• Source: Faculdade de Ciências Médicas da Santa Casa de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pulmonary hypertension (HP) is a progressive pathological condition presents with vascular changes in the lung. Cardiopulmonary changes in PH are considered the main limiting factor, however, it is known that the muscular alterations potentiate the symptomatology. Several HP factors and mechanisms have an impact on peripheral and respiratory muscle changes, so, specifically, respiratory muscles are also altered in patients with PH. In the face of respiratory muscle weakness, inspiratory muscle training (IMT) has been shown to increase respiratory muscle strength and functional capacity in chronic conditions such as obstructive pulmonary disease (COPD) and heart failure (HF). The objective of this study is to test whether a 12-week TMI protocol is capable of impacting functional capacity, respiratory muscle strength, spirometric values and quality of life in patients with PH.

Description:

Pulmonary hypertension (HP) is a progressive pathological condition that HP presents with vascular changes in the lung that cause proliferative and obstructive remodeling promoting vasoconstriction with a consequent increase in pulmonary vascular resistance (PVR). Cardiopulmonary changes in PH are considered the main limiting factor, however, it is known that the muscular alterations potentiate the symptomatology. Several HP factors and mechanisms have an impact on peripheral and respiratory muscle changes, such as: decreased cardiac output, hypoxemia, inflammation, increased insulin resistance, altered autonomic nervous system (ANS) response, and muscle disuse. These factors imply alteration of fiber type, atrophy, capillary vascular reduction, reduction of oxidative capacity, endothelial dysfunction and decreased muscle excitability by ANS. Specifically, respiratory muscles are also altered in patients with PH. For the treatment of PH, in addition to optimized drug therapy, studies have demonstrated the effects of physical exercise for this population. Although there is no consensus about the best exercise modality, duration, frequency or intensity, physical training promotes benefits in exercise capacity, maximal oxygen capacity (VO2peak) and quality of life. The most recent European guideline [3] recommends supervised exercise in patients with PH who are clinically stable with optimized drug therapy (evidence grade IIa, Level B), but patients often do not have access to supervised physical rehabilitation programs, which Practice a challenge. In the face of respiratory muscle weakness, inspiratory muscle training (IMT) has been shown to increase respiratory muscle strength and functional capacity in chronic conditions such as obstructive pulmonary disease (COPD) and heart failure (HF). At HP, the study by Saglam M et al., 2015 demonstrates improvement of respiratory muscle strength and functional capacity, resulting in decreased dyspnea and fatigue in PH patients who performed the IMT protocol during six weeks of outpatient training. The objective of this study is to test whether a 12-week TMI protocol is capable of impacting functional capacity, respiratory muscle strength, spirometric values and quality of life in patients with PH.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 10, 2020
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Pulmonary hypertension (PAP m = 25mmHg and PAOP <15mmHg);
• both sexes and age greater than or equal to 18 years;
• Clinically stable with optimized and unchanged daily drug therapy in the last three months;
• agree to participate in the study by signing a free and informed consent form

Exclusion Criteria:

• Down's syndrome
• COPD
• Severe ischemic heart disease
• Left heart failure
• Cor pulmonale
• Cognitive Disorders
• Orthopedic problems that interfere with assessments and interventions
• Emergency or elective surgical intervention during the protocol
• Pulmonary infectious process during the protocol.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Respiratory Muscle Strength

Intervention

Other:
• respiratory muscle training
The TMI protocol will be performed with POWERbreathe Line Plus (POWERbreathe International Ltd. Warwickshire, England) linear loader with resistance load of 30% of maximal inspiratory pressure (PImax) value for a period of 12 weeks, 7 times at Week, 30 min / day, one of the times in the week with the supervision of the researcher and, on the other six days of the week, patients will perform IMT at their homes, having as a control a records record of the protocol that will be delivered to each patient To record the time and duration of the exercise. At the end of each week, patients will be reevaluated for MIP, so that the load values are regulated according to the possible increase in inspiratory muscle strength. The data collection will be performed by a single evaluator and the patients will be properly oriented on the procedures to be performed.
• sham muscle training
sham comparator

Locations

Country	Name	City	State
Brazil	Santa Casa of Sao Paulo Medical School	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Ciências Médicas da Santa Casa de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (10)

ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. Erratum in: Am J Respir Crit Care Med. 2016 May 15;193(10):118 — View Citation

Ehlken N, Verduyn C, Tiede H, Staehler G, Karger G, Nechwatal R, Opitz CF, Klose H, Wilkens H, Rosenkranz S, Halank M, Grünig E. Economic evaluation of exercise training in patients with pulmonary hypertension. Lung. 2014 Jun;192(3):359-66. doi: 10.1007/s — View Citation

Galiè N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper — View Citation

Gosselink R, De Vos J, van den Heuvel SP, Segers J, Decramer M, Kwakkel G. Impact of inspiratory muscle training in patients with COPD: what is the evidence? Eur Respir J. 2011 Feb;37(2):416-25. doi: 10.1183/09031936.00031810. Review. — View Citation

Hoeper MM, Bogaard HJ, Condliffe R, Frantz R, Khanna D, Kurzyna M, Langleben D, Manes A, Satoh T, Torres F, Wilkins MR, Badesch DB. Definitions and diagnosis of pulmonary hypertension. J Am Coll Cardiol. 2013 Dec 24;62(25 Suppl):D42-50. doi: 10.1016/j.jac — 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

Neder JA, Andreoni S, Lerario MC, Nery LE. Reference values for lung function tests. II. Maximal respiratory pressures and voluntary ventilation. Braz J Med Biol Res. 1999 Jun;32(6):719-27. — View Citation

Saglam M, Arikan H, Vardar-Yagli N, Calik-Kutukcu E, Inal-Ince D, Savci S, Akdogan A, Yokusoglu M, Kaya EB, Tokgozoglu L. Inspiratory muscle training in pulmonary arterial hypertension. J Cardiopulm Rehabil Prev. 2015 May-Jun;35(3):198-206. doi: 10.1097/H — View Citation

Simonneau G, Galiè N, Rubin LJ, Langleben D, Seeger W, Domenighetti G, Gibbs S, Lebrec D, Speich R, Beghetti M, Rich S, Fishman A. Clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2004 Jun 16;43(12 Suppl S):5S-12S. Review. — View Citation

Simonneau G, Gatzoulis MA, Adatia I, Celermajer D, Denton C, Ghofrani A, Gomez Sanchez MA, Krishna Kumar R, Landzberg M, Machado RF, Olschewski H, Robbins IM, Souza R. Updated clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2013 Dec — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory muscle strength	Inspiratory Muscle strength	3 months
Primary	Walk test	6 minute distance walk test	3 months