NCT03186092

Effects of Training in Pulmonary Hypertension

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Respiratory Muscle Strength

Interventions

Type	Name	Description
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.
OTHER	sham muscle training	sham comparator

Timeline

• Start date: 2017-08-01
• Primary completion: 2018-03-01
• Completion: 2020-12-10
• First posted: 2017-06-14
• Last updated: 2021-02-05

Locations

1 site across 1 country: Brazil