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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034714
Receipt No. R000038394
Official scientific title of the study Efficacy and safety of hybrid therapy combined with branched-chain amino acid and resistance training in frail patients with cardiovascular disease
Date of disclosure of the study information 2018/11/01
Last modified on 2018/10/31

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Basic information
Official scientific title of the study Efficacy and safety of hybrid therapy combined with branched-chain amino acid and resistance training in frail patients with cardiovascular disease
Title of the study (Brief title) 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 Masakazu Saitoh
Organization Sakakibara Heart Institute
Division name Department of Rehabilitation
Address 3-16-1, Asahicho, Fuchu, Tokyo, Japan
TEL 042-314-3111
Email msaitoh@shi.heart.or.jp

Public contact
Name of contact person Masakazu Saitoh
Organization Sakakibara Heart Institute
Division name Department of Rehabilitation
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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 07 Month 10 Day
Anticipated trial start date
2018 Year 08 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

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


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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