Japanese multi-center randomized control trial of physical therapy for older patients with acute heart failure and frailty

UMIN ID: UMIN000053956

Registered date:01/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Older patients with heart failure
• Date of first enrollment: 2024/09/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A systemic personal exercise intervention
Conventional ecercise training

Outcome(s)

• Primary Outcome: Short physical performance battery
• Secondary Outcome: Grip strength Gait speed Arm, Calf circumference Barthel Index J-CHS Criteria, Clinical Frailty Scale, MAKIZAKO, KCL EQ-5D-5L One year mortality or hospitalization

Key inclusion & exclusion criteria

• Age minimum: 65years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: At the time of randomization, none of the following conditions may exist: Acute myocardial infarction based on clinical diagnosis Requiring care in an intensive care unit Planned discharge other than to where the participant will live independently Dementia that precludes ability to participate in rehabilitation and follow study protocols Impairment from stroke, injury or other medical disorder that precludes participation in the intervention Advanced chronic kidney disease or dialysis Prior cardiac transplantation or planned within the next 6 months Expected use of continuous intravenous inotropic therapy after discharge Ventricular assist device or anticipated within the next 6 months Severe aortic valve stenosis Already actively participating in facility-based cardiac rehabilitation Anticipated hospital discharge before baseline study measures could be completed SPPB score more than or equal to 10 points

Related Information

• Primary Sponsor: Fujita Health University Hospital Kitasato University Hospital Sapporo Medical University Hospital Shinshu University Hospital Tohoku University Hospital Matsushita Memorial Hospital
• Source(s) of Monetary Support: Grants-in-Aid for Scientific Research C