Effect of exercise training on heart failure with preserved ejection fraction complicated with type 2 diabetes mellitus

UMIN ID: UMIN000055635

Registered date:26/09/2024

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Heart failure with preserved ejection fraction, type 2 diabetes mellitus
• Date of first enrollment: 2017/04/01
• Target sample size: 160
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Moderate-intensity exercise training
Moderate-intensity exercise training

Outcome(s)

• Primary Outcome: Occurrence of a composite endpoint of heart failure-related readmission or all-cause mortality after the end of the 5-month exercise-training intervention.
• Secondary Outcome: Changes in peak oxygen uptake from baseline following exercise training intervention

Key inclusion & exclusion criteria

• Age minimum: 65years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1.Exacerbation of subjective symptoms of heart failure(dyspnea, fatigue, etc.) within the past week 2.Unstable angina or low threshold (induced by slow walking on level ground 2METs) myocardial ischemia 3.Severe valvular disease for which surgery is indicated, especially aortic stenosis 4.Severe left ventricular outflow tract stenosis (obstructive hypertrophic cardiomyopathy) 5.Untreated exercise-induced severe arrhythmia (ventricular fibrillation, persistent ventricular tachycardia) 6.Active myocarditis 7.Acute systemic disease or fever 8.Other diseases for which exercise therapy is contraindicated (moderate or higher aortic aneurysm, severe hypertension, thrombophlebitis, embolism within 2 weeks, serious other organ damage, etc.) 9.Patients with congenital cardiovascular disease 10.Renal failure with estimated glomerular filtration rate <30 11.Persons who have been diagnosed with psychiatric disorders 12.Malignant tumor 13.Persons who fall under the NYHA classification <New York Heart Association functional classification> grade I (patients with heart disease with no restrictions on physical activity) and grade IV (patients with heart disease who have symptoms in any physical activity) 14.65 years old or younger, 80 years old or older

Related Information

• Primary Sponsor: National University Corporation Tsukuba University of Technology
• Source(s) of Monetary Support: Japan Society for the Promotion of Science