UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034714 |
|---|---|
| Receipt number | R000038394 |
| Scientific Title | 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 | 2022/02/24 15:07:29 |
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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
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
msaitoh@shi.heart.or.jp
Sponsor or person
Institute
Sakakibara Heart Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038394
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| Registered date | File name |
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