Efficacy of inspiratory muscle training in older patients with Acute Heart Failure: multi-arm randomized controlled trial

UMIN ID: UMIN000055454

Registered date:01/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Older patients with acute heart failure
• Date of first enrollment: 2024/10/01
• Target sample size: 66
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

High intensity nspiratory muscle training Duration: From study enrollment to discharge Load: PI-max 60%. Times: 15 times per session, 3 sets per day Frequency: at least 5 days per week
Low intensity inspiratory muscle training Duration: From study enrollment to discharge Load: PI-max 30%. Times: 15 times per session, 3 sets per day Frequency: at least 5 days per week
Sham inspiratory muscle training Duration: From study enrollment to discharge Load: PI-max 0%. Times: 15 times per session, 3 sets per day Frequency: at least 5 days per week

Outcome(s)

• Primary Outcome: 2-minute walk distance (measured at baseline and at discharge)
• Secondary Outcome: Change in dyspnea and lower-limb fatigue before and after 2-minute walk distance, EuroQol 5-dimensional 5-level, physical activity, inspiratory and expiratory muscle strength, diaphragm thickness, tongue pressure, and respiratory sarcopenia (measured at baseline and at discharge) Number and type of adverse events and changes in vital signs with inspiratory muscle training

Key inclusion & exclusion criteria

• Age minimum: 65years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)Acute myocardial infarction 2)Requiring care in an intensive care unit 3)Severe dementia 4)Impairment from stroke, injury, impaired consciousness, psychiatric disorder or other medical disorder that precludes participation in the intervention 5)Advanced chronic kidney disease (eGFR < 20 mL/min/1.73 m2) or dialysis 6)Prior cardiac transplantation or planned within the next 6 months 7)Expected use of continuous intravenous inotropic therapy after discharge 8)VAD, IMPELLA, or IABP is required or anticipated within the next 6 months 9)Expected use of continuous intravenous inotropic therapy after discharge 10)Uncontrolled diabetes (HbA1c > 8.4%) 11)Peripheral arterial disease (Fontain III or IV) 12)Severe anemia (hemoglobin < 8.0g/dl) 13)Patients who needed assistance for walking a month before hospitalization 14)Patients with mechanical ventilation and non-invasive positive pressure ventilation 15)Diseases and clinical conditions that are absolute contraindications to aggressive exercise training -Unstable angina or low-threshold myocardial ischemia induced by slow walking (2 METs) on a flat surface -Uncontrolled arrhythmias causing hemodynamic abnormalities (ventricular fibrillation, sustained ventricular tachycardia) -Severe valvular disease indicated for surgery, especially symptomatic aortic stenosis -Severe left ventricular outflow tract stenosis due to obstructive hypertrophic cardiomyopathy, etc. -Acute pulmonary embolism, pulmonary infarction and deep vein thrombosis -Active myocarditis, pericarditis, endocarditis -Acute systemic disease -Acute aortic dissection -Moderate or severe aortic aneurysm -Severe hypertension -Thrombophlebitis -Embolism within 2 weeks -Serious organ diseases -Mental or physical impairment that interferes with safe implementation of exercise training 16)Diseases affecting respiratory muscle strength -Neuromuscular diseases -Respiratory diseases 17)Orthopedic diseases affecting gait

Related Information

• Primary Sponsor: Other
• Source(s) of Monetary Support: MEXT(Japan)