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Effects of Home-based Long-term Electrical Muscle Stimulation on Physical Function in Frailty Older Patients with Cardiovascular Disease: a randomized controlled trial

Effects of Home-based Long-term Electrical Muscle Stimulation on Physical Function in Frailty Older Patients with Cardiovascular Disease: a randomized controlled trial - FITNESS trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000054434
Enrollment
40
Registered
2024-05-19
Start date
2024-06-19
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

Frailty older patients with cardiovascular disease

Interventions

1) Usual cardiac rehabilitation 2) Electrical muscle stimulation training (5 sessions per week for 8 weeks, with each session lasting 20 minutes) 1) Usual cardiac rehabilitation

Sponsors

Kitasato University School of Allied Health Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients hospitalized for cardiovascular disease and prescribed cardiac rehabilitation 2) Patients within 7 days of admission 3) Patients aged 65 years or older 4) Patients with frailty (Short Physical Performance Battery score of 4-9)

Exclusion criteria

Exclusion criteria: 1) Patients undergoing hemodialysis 2) Patients with severe aortic stenosis 3) Patients with severe left ventricular outflow tract obstruction 4) Patients with untreated exercise-induced severe arrhythmia (ventricular fibrillation, sustained ventricular tachycardia) 5) Patients with uncontrolled hypertension or diabetes mellitus 6) Peripheral arterial disease (Fontaine classification of III or higher) 7) Patients undergoing home oxygen therapy 8) Unstable angina pectoris (myocardial ischemia induced by exercise less than 3 METs) 9) Patients who have difficulty in giving consent to participate in the study due to cognitive decline 10) Patients who require help in walking before admission 11) Patients with orthopedic conditions that interfere with ambulation 12) Pregnant, lactating, or possibly pregnant patients 13) Patients with a body mass index of 30 kg/m2 or more 14) Known and documented neuromuscular disease 15) Patients with a pacemaker or implantable cardioverter defibrillator (ICD) 16) Patients who are scheduled to be hospitalized within 2 months after discharge for standby surgery, pacemaker or ICD implantation, or for close examination 17) Patients deemed inappropriate by the attending physician 18) Patients who live in a facility or transferred from other hospitals 19) Short life expectancy due to advanced disease such as malignancy other than heart failure

Design outcomes

Primary

MeasureTime frame
Change in quadriceps isometric strength (measurements at baseline and 8 weeks after hospital discharge)

Secondary

MeasureTime frame
Change in physical function, body composition, quality of life, and physical activity (measurements at baseline and 8 weeks after discharge) Improvement in frailty at the end of follow-up Presence or absence of sarcopenia at the end of follow-up and change in score (measurements at baseline and 8 weeks after discharge) Change in cognitive function (measurements at baseline and 8 weeks after discharge) and presence or absence of cognitive decline Recurrence or rehospitalization for cardiovascular disease, all-cause or cardiovascular disease-related deaths, or falls during follow-up Adherence to intervention, adverse events associated with the intervention, and retention in outpatient rehabilitation Subgroup analysis (statistical significance level of p-value for interaction: <0.1): age (stratified at median value), gender (male, female), quadriceps isometric strength at baseline (stratified at median value), diagnostic category (heart failure, acute coronary syndrome, other)

Countries

Japan

Contacts

Public ContactKentaro Kamiya

Kitasato University School of Allied Health Sciences

k-kamiya@kitasato-u.ac.jp042-778-9250

Outcome results

None listed

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