Effects of Outpatient Cardiac Rehabilitation and Home Exercise Therapy in Patients with Heart Failure

JRCT ID: jRCT1030230680

Registered date:06/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart failure
• Date of first enrollment: 06/03/2024
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Outpatient cardiac rehabilitation and home exercise therapy

Outcome(s)

• Primary Outcome: six-minute walk distance
• Secondary Outcome: Short Physical Performance Battery (SPPB), gait speed, Kansas City Cardiomyopathy Questionnaire (KCCQ), Fried crirteria, Frailty index

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include criteria

1) Patients aged 18 years and over
2) Patients with compensated heart failure
(i) stable weight without increased diuretics for more than 1 week
(ii) no symptoms of congestion (no orthopnea, edema, ascites, jugular vein rage)
(iii) no anginal symptoms, no arrhythmias of clinical concern
(iv) systolic blood pressure more than or equal to 80 mmHg and no orthostatic hypotension
3) Patients scheduled for induction of outpatient cardiac rehabilitation
4) Patients with basic ADLs
5) Patients with written informed consent

Exclude criteria

1) Pulmonary arterial hypertension, significant left heart valvular disease (severe regurgitation or moderate or greater stenosis), cardiomyopathy, acute coronary syndrome, complex adult congenital heart disease
2) Patients with severe orthopaedic disease that makes it difficult to implement a cardiac rehabilitation programme.
3) Patients with dementia, which makes it difficult to implement cardiac rehabilitation programmes.
4) Patients with contraindications to resistance training (1) NYHA classification IV, (2) left ventricular outflow tract stenosis, (3) non-compensated heart failure, (4) uncontrolled arrhythmia (increasing trend of supraventricular and ventricular arrhythmias), (5) severe and symptomatic aortic stenosis, (6) uncontrolled diabetes mellitus, and (7) uncontrolled uncontrolled hypertension (>180/110 mmHg), (8) severe pulmonary hypertension (mean pulmonary arterial pressure >55 mmHg), (9) complicated by acute aortic dissection (thrombosed), (10) severe heart failure (terminal ))
(5) Patients with an implanted pacemaker or defibrillator with heart rate limitation.
(6) Patients deemed unsuitable as research subjects by the principal investigators and subinvestigators.

Related Information

• Primary Sponsor: Obokata Masaru