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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000019551
Enrollment
80
Registered
2015-10-28
Start date
2016-01-29
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

Frail elderly patients with acute decompensated heart failure

Interventions

1) Early rehabilitation program 2) Electrical muscle stimulation for 30-40 minutes per day, 5 days per week, 2 weeks 1) Early rehabilitation program

Sponsors

Kitasato University Hospital
Lead Sponsor
Kitasato University Medical Center, Kameda Medical Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who were hospitalized for acute exacerbation of heart failure 2) Aged 75 years or older 3) Frail patients (Short Physical Performance Battery score 4-9)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Quadriceps Strength [Time Frame: Measured at baseline and 2 weeks]

Secondary

MeasureTime frame
Physical function, Six-minute walk distance, Cognitive function, Cardiac and renal function [Time Frame: Measured at baseline and 2 weeks] Subgroup analysis (Statistical significance level of p-value for interaction: <0.1): Gender, LVEF >=50%, Quadriceps strength >median value, six-minute walk distance >median value, Age >=85 years

Countries

Japan

Contacts

Public ContactShinya Tanaka

Kitasato University Graduate School of Medical Sciences

tanashin.pt@gmail.com042-778-9081

Outcome results

None listed

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