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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055454
Enrollment
66
Registered
2024-10-01
Start date
2024-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Older patients with acute heart failure

Interventions

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 intensi

Sponsors

Other
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients over 65 years old admitted to the National Hospital Organization Sendai Medical Center with a diagnosis of acute heart failure and prescribed cardiac rehabilitation by a physician. 2)Patients who have been informed about the study and obtained written consent from the individual. 3)Patients who have inspiratory muscle weakness on examination at the start of cardiac rehabilitation 4)Patients who are implementable the 2-minute walk test on the examination at the start of cardiac rehabilitation.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
2-minute walk distance (measured at baseline and at discharge)

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactRen Takahashi

Hirosaki University Graduate School of Health Sciences Division of Comprehensive Rehabilitation Sciences

h24dh405@hirosaki-u.ac.jp022-293-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026