Effects of acute phase intensive electrical muscle stimulation in frail elderly patients with acute decompensated heart failure: The ACTIVE-EMS Randomized Controlled Trial

Not Applicable

• Conditions: Frail elderly patients with acute decompensated heart failure

• Registration Number: JPRN-UMIN000019551
• Lead Sponsor: Kitasato University Hospital

Brief Summary

The inclusion of EMS therapy in addition to exercise-based early cardiac rehabilitation yielded significantly improved lower extremity function without adverse events in frail patients aged 75 years and older with acute heart failure

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-28
• Study Completion: 2020-03-31
• Results First Posted: 2022-02-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

1) BNP < 100 pg/ml at admission 2) Cognitive dysfunction 3) Acute coronary syndrome 4) Significant myocardial ischemia during low-intensity exercise 5) Resting heart rate > 120/min 6) Acute infective endocarditis, myocarditis, and pericaritis 7) Presence of a recent hospitalization for heart failure (< 1 month) 8) Severe symptomatic aortic stenosis, mitral stenosis, and hypertrophic obstructive cardiomyopathy 9) Severe pulmonary hypertension 10) Intracardiac thrombus 11) Untreated life-threatening arrhythmia 12) Resting blood pressure > 180 mmHg 13) Ongoing orthopnea 14) Requiring high inotropic support 15) Patients with circulatory assist device 16) Patients with inadequate oxygenation 17) Patients with mechanical ventilation 18) History of aortic dissection, or presence of aortic aneurysm or aortic dissection 19) Patients with uncontrolled diabetes 20) Peripheral arterial disease (Fontain 3-4) 21) Recent embolism 22) Patients undergoing hemodialysis 23) Serum creatinine > 3.0 mg/dl 24) Severe anemia 25) Short life expectancy due to advanced disease other than heart failure 26) Patients who needed assistance for walking a month before hospitalization 27) Pregnant, lactational woman, patients may be pregnant

Study & Design

• Study Type: Interventional
• Study Design: Not specified