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Clinical Trials/NCT03186092
NCT03186092CompletedNot Applicable

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

Faculdade de Ciências Médicas da Santa Casa de São Paulo2 sites in 1 country14 target enrollmentStarted: August 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
14
Locations
2
Primary Endpoint
Walk test

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Masking Description

The equipment is the same for both groups. The change is internal, in the placebo group, patients train without a spring that imposes the load for respiratory muscle training.

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • 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.

Outcomes

Primary Outcomes

Walk test

Time Frame: 3 months

6 minute distance walk test

Respiratory muscle strength

Time Frame: 3 months

Inspiratory Muscle strength

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Profa. Dra. Vera Lúcia dos Santos Alves

PhD Health Science and Head of Cardiorespiratory Physiotherapy

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Study Sites (2)

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