Efficacy of an Inspiratory Muscle Training Protocol With Resistive Airflow Loading on Exercise Capacity, Respiratory Muscle Strength and Quality of Life in Individuals With Heart Failure: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Exercise capacity
研究概览
简要总结
Heart failure is frequently associated with inspiratory muscle weakness, which contributes to dyspnea, reduced exercise capacity, impaired quality of life, and adverse cardiovascular outcomes. Although inspiratory muscle training (IMT) is a recommended adjunct to cardiovascular rehabilitation, the optimal training modality remains uncertain, particularly among patients with reduced and preserved ejection fraction.
This randomized controlled trial will evaluate the efficacy of a novel inspiratory muscle training protocol using tapered flow resistive loading (TFRL) compared with conventional threshold loading (TL) and usual care. A total of 108 clinically stable patients with heart failure (NYHA class II-III) will be enrolled. Participants will be stratified according to heart failure phenotype (reduced or preserved ejection fraction) and allocated to one of three groups: TFRL, TL, or control. Both training interventions will be performed for 8 weeks in combination with supervised exercise-based cardiac rehabilitation.
Primary and secondary outcomes will include inspiratory muscle strength and endurance, exercise capacity, pulmonary function, dyspnea, skeletal muscle oxygenation, autonomic balance, arterial stiffness, and health-related quality of life. The study is powered to detect moderate between-group differences and interaction effects with 80% statistical power and a two-sided alpha level of 0.05. Changes over time and between groups will be analyzed using analysis of covariance (ANCOVA), adjusting for baseline inspiratory muscle strength.
The trial aims to determine whether TFRL provides superior clinical and physiological benefits compared with conventional inspiratory muscle training and whether treatment responses differ according to heart failure phenotype.
详细描述
Heart failure (HF) is a complex clinical syndrome characterized by the inability of the cardiovascular system to deliver sufficient blood flow and oxygen to meet the metabolic demands of peripheral tissues. It affects more than 64 million people worldwide and remains one of the leading causes of hospitalization, disability, and mortality among adults. Despite advances in pharmacological and device-based therapies, many patients continue to experience symptoms such as dyspnea, fatigue, exercise intolerance, and impaired quality of life. These symptoms are major determinants of disease burden and frequently persist despite optimal medical management.
Although heart failure has traditionally been considered a disorder primarily involving cardiac dysfunction, increasing evidence indicates that peripheral and respiratory impairments substantially contribute to functional limitations. Among these, inspiratory muscle weakness has emerged as an important and potentially modifiable factor. Reduced inspiratory muscle strength is common in patients with both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) and has been associated with reduced exercise capacity, increased dyspnea, impaired ventilatory efficiency, autonomic dysfunction, and poorer clinical outcomes.
The pathophysiological consequences of inspiratory muscle weakness extend beyond the respiratory system. During exercise, fatigued respiratory muscles activate the respiratory muscle metaboreflex through stimulation of group III and IV afferent fibers. This reflex increases sympathetic nervous system activity and promotes peripheral vasoconstriction, particularly in locomotor muscles. As a consequence, blood flow is redistributed from exercising skeletal muscles toward the respiratory muscles, accelerating peripheral fatigue and limiting exercise tolerance. This mechanism contributes to the reduced functional capacity commonly observed in patients with heart failure.
Several studies have demonstrated that inspiratory muscle training (IMT) can improve inspiratory muscle strength and endurance, reduce dyspnea, enhance exercise performance, improve ventilatory efficiency, and increase quality of life. Additional evidence suggests that IMT may positively influence autonomic regulation, muscle oxygenation, endothelial function, and cardiovascular health. Consequently, inspiratory muscle training has become an increasingly important adjunctive therapy within cardiovascular rehabilitation programs.
Despite these promising findings, important questions remain unanswered. First, the optimal inspiratory muscle training modality for patients with heart failure has not been established. Most previous studies have employed inspiratory pressure-threshold devices. These devices require patients to generate a predetermined inspiratory pressure before airflow occurs, resulting in resistance that may not be maintained uniformly throughout the inspiratory maneuver. Consequently, the amount of inspiratory work performed during each breath may be limited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of symptomatic heart failure (NYHA functional class I and III).
- •Participants able to understand and respond to the instructions given in the study
- •Participants with stable disease at the moment of inclusion in this study.
- •Unaltered dose and type of medication up to three months before the start of the study
排除标准
- •Participants unable to perform a valid baseline cardiopulmonary exercise test.
- •Participants with unstable angina, acute myocardial infarction, and/or heart surgery within the past three months.
- •Participants with other concomitant cardiac or neurological disease.
- •Participants with difficulties in maintaining a proper mouth seal or unable to avoid air leakage during pulmonary function testing.
- •Participants in other non-pharmacological study will be also excluded.
- •Current smokers.
- •Cardiac acute decompensation.
结局指标
主要结局
Exercise capacity
时间窗: From enrollment to the end of treatment at 8 weeks
Improve cardiorespiratory capacity assessed peak oxygen uptake (VO2peak)
Maximal inspiratory muscle strength
时间窗: From enrollment to the end of treatment at 8 weeks
Improve maximal inspiratory pressure which implies an increase in the values measured in millimeters of mercury (mmHg).
Arterial stiffness
时间窗: From enrollment to the end of treatment at 8 weeks
Decrease in pulse wave velocity measured using a Holter blood pressure monitor.
次要结局
- Health related quality of life(From enrollment to the end of treatment at 8 weeks)
研究者
Marcelo Tuesta
Doctor of Philosophy degree
Universidad Nacional Andres Bello
