UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of hybrid therapy combined with branched-chain amino acid and resistance training in frail patients with cardiovascular disease
Acronym	Branched-chain amino acid and resistance training in frail patients with cardiovascular disease
Scientific Title	Efficacy and safety of hybrid therapy combined with branched-chain amino acid and resistance training in frail patients with cardiovascular disease
Scientific Title:Acronym	Branched-chain amino acid and resistance training in frail patients with cardiovascular disease
Region	Japan

Condition
Condition	frail patients with cardiovascular disease
Classification by specialty	Cardiology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the effects of hybrid therapy combined with BCAA supplementation and resistance training in frail patients with cardiovascular disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in skeletal muscle mass after 12-week intervention
Key secondary outcomes	Muscle strength: handgrip strength and isomertic leg strength Short physical performance battery (SPPB) Sarcopenia: AWGS criteria Frailty: J-CHS, Essential frail toolkit eGFR: serum creatinin, cystatin C

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food Behavior,custom
Interventions/Control_1	Intervention: BCAA suplementation + resistance training, 12weeks, 2-3/week
Interventions/Control_2	control: placebo + resistance training, 12weeks, 2-3/week
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	CKD patients (eGFR is above 60ml/min/1.73m2) with cardiovascular disease who participate in the outpatients cardiac rehabilitation program
Key exclusion criteria	Dysphagia, Severe mobility limitations due to stroke or orthopedic disease, Uncontrolled cardiovascular disease, Diagnosis or treatment of cancer,Cognitive impairment; MOCA-J is above 26points, hemodialysis therapy
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Masatoshi Middle name Last name Nagayama
Organization	Sakakibara Heart Institute
Division name	Department of General medicine
Zip code	1830003
Address	3-16-1, Asahicho, Fuchu, Tokyo, Japan
TEL	042-314-3111
Email	msaitoh@shi.heart.or.jp

Public contact
Name of contact person	1st name Masakazu Middle name Last name Saitoh
Organization	Sakakibara Heart Institute
Division name	Department of Rehabilitation
Zip code	1830003
Address	3-16-1, Asahicho, Fuchu, Tokyo, Japan
TEL	042-314-3111
Homepage URL
Email	msaitoh@shi.heart.or.jp

Sponsor
Institute	Sakakibara Heart Institute
Institute
Department

Funding Source
Organization	Sakakibara Heart Institute
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Department of Clinical trial support
Address	3-16-1, Asahicho, Fuchu, Tokyo, Japan
Tel	042-314-3111
Email	kenkyu@shi.heart.or.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	18-024
Org. issuing International ID_1	Sakakibara Heart Institute
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 11 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	Completed
Date of protocol fixation	2018 Year 07 Month 10 Day
Date of IRB	2018 Year 06 Month 18 Day
Anticipated trial start date	2021 Year 03 Month 31 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry	2021 Year 08 Month 31 Day
Date trial data considered complete	2021 Year 08 Month 31 Day
Date analysis concluded	2022 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 10 Month 31 Day
Last modified on	2022 Year 02 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038394