臨床研究等提出・公開システム

Date of registration	Mar. 06, 2024
Last modified on	Mar. 06, 2024
Trial ID	jRCT1030230680

Scientific Title	Effects of Outpatient Cardiac Rehabilitation and Home Exercise Therapy in Patients with Heart Failure: TRANSITION-HF (TRANSITION-HF )
Public Title	Effects of Outpatient Cardiac Rehabilitation and Home Exercise Therapy in Patients with Heart Failure

Contact for Scientific Queries	Name	Obokata Masaru
	Affiliation	Gunma University Hospital
	Address	3-39-15 Showa-machi, Maebashi, Gunma
	Telephone	+81-27-220-8145
	E-mail	obokata.masaru@gunma-u.ac.jp
Contact for Public Queries	Name	Obokata Masaru
	Affiliation	Gunma University Hospital
	Address	3-39-15 Showa-machi, Maebashi, Gunma
	Telephone	+81-27-220-8145
	E-mail	obokata.masaru@gunma-u.ac.jp

Recruitment status	Recruiting


Anticipated date of first enrollment		Mar. 06, 2024
Target sample size		50
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion 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
	Exclusion 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.
	Age Minimum	18age old over
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		Heart failure
Intervention(s)		Outpatient cardiac rehabilitation and home exercise therapy
Health Condition(s) Keyword		heart failure
Intervention(s) Keyword		cardiac rehabilitation, home exercise therapy
Primary Outcome(s)		six-minute walk distance
Secondary Outcome(s)		Short Physical Performance Battery (SPPB), gait speed, Kansas City Cardiomyopathy Questionnaire (KCCQ), Fried crirteria, Frailty index

Primary Sponsor	Gunma University Hospital

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Gunma University Hospital, Clinical Research Review Board
Address	3-39-15 Showa-machi, Maebashi, Gunma, Gunma
Telephone	+81-27-220-8740
E-Mail	irb-jimukk-ciru@ml.gunma-u.ac.jp
Approval Status	Not approval
Date of approval	Nov. 10, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none