Frailty older patients with cardiovascular disease
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Change in quadriceps isometric strength (measurements at baseline and 8 weeks after hospital discharge) | — |
Secondary
| Measure | Time 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
Kitasato University School of Allied Health Sciences