UMIN-CTR Clinical Trial

Basic information
Public title	Effect of preoperative rehabilitation for elderly patients awaiting elective coronary artery bypass and valvular surgery with frailty
Acronym	Effect of preoperative rehabilitation for elderly patients awaiting elective coronary artery bypass and valvular surgery with frailty
Scientific Title	Effect of preoperative rehabilitation for elderly patients awaiting elective coronary artery bypass and valvular surgery with frailty
Scientific Title:Acronym	Effect of preoperative rehabilitation for elderly patients awaiting elective coronary artery bypass and valvular surgery with frailty
Region	Japan

Condition
Condition	Ischemic heart disease Valvular heart disease
Classification by specialty	Cardiology Cardiovascular surgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to investigate the effect of preoperative rehabilitation for elderly patients awaiting cardiac surgery with frailty.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Japanese version of the Cardiovascular Health Study (J-CHS) standard, Short Physical Performance Battery (SPPB), and 6-minute walking test are evaluated before and after the preoperative rehabilitation intervention.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Perform rehabilitation interventions 2-3 times a week. Time is 60 minutes each time, exercise intensity is HR at AT (anaerobic threshold) calculated by cardiopulmonary exercise test, or 40-60% HRR (Heart Rate Reserve), PRE (Rate of Perceived exertion) 12- Let it be 13.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Elective surgery for coronary artery bypass or mitral valve replacement/plasty 65 years of age or older frail or pre-frail Preoperative examination No ischemic symptoms or abnormal vital signs are observed below AT in the exercise stress test
Key exclusion criteria	NYHA IV Exacerbation of subjective symptoms of heart failure within 1 week Unstable angina Untreated exercise-induced arrhythmia Severe aortic valve stenosis Severe left ventricular outflow tract stenosis Ischemic symptoms or abnormal vital signs below AT Cognitive dysfunction ADL is not independent
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kazuhisa Middle name Last name Domen
Organization	Hyogo college of medicine
Division name	Department of rehabilitation medicine
Zip code	6638501
Address	1-1 Mukogawa-cho, Nishinomiya-shi, Hyogo
TEL	0798456111
Email	domen@hyo-med.ac.jp

Public contact
Name of contact person	1st name Yosuke Middle name Last name Honda
Organization	Hospital of Hyogo college of medicine
Division name	Department of rehabilitation
Zip code	6638501
Address	1-1 Mukogawa-cho, Nishinomiya-shi, Hyogo
TEL	0798456111
Homepage URL
Email	yosuke12@hyo-med.ac.jp

Sponsor
Institute	Hyogo college of medicine
Institute
Department

Funding Source
Organization	Hyogo college of medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hyogo college of medicine
Address	1-1 Mukogawa-cho, Nishinomiya-shi, Hyogo
Tel	0798456066
Email	rinri@hyo-med.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2021 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date	2021 Year 10 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 08 Month 26 Day
Last modified on	2021 Year 08 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051707