UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038537 |
|---|---|
| Receipt number | R000043919 |
| Scientific Title | The study investigating factors associated with the recovery of frailty during cardiac rehabilitation |
| Date of disclosure of the study information | 2019/11/11 |
| Last modified on | 2024/05/17 15:29:06 |
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Basic information
Public title
The study investigating factors associated with the recovery of frailty during cardiac rehabilitation
Acronym
FRAILREHAB
Scientific Title
The study investigating factors associated with the recovery of frailty during cardiac rehabilitation
Scientific Title:Acronym
FRAILREHAB
Region
| Japan |
Condition
Condition
Patients on cardiac rehabilitation
Classification by specialty
| Medicine in general | Cardiology | Geriatrics |
| Surgery in general | Vascular surgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify factors affect flail index improvement in patients undergoing cardiac rehabilitation
Basic objectives2
Others
Basic objectives -Others
Exploratory research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SPPB and its components (gait speed, up and go test), grip strength, physical activity for 4 months
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing cardiac rehabilitation. Patients who can obtain written consent from the person to participate in this study.
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Konishi |
Organization
Yokohama City University
Division name
Department of Medical Science and Cardiorenal Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, 236-0004 Yokohama
TEL
+810457872635
m_koni@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Konishi |
Organization
Yokohama City University
Division name
Department of Medical Science and Cardiorenal Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, 236-0004 Yokohama
TEL
+810457872635
Homepage URL
m_koni@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Japan Society of the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical and Hospital Management Department Clinical Research Promotion Section
Address
1-1-1 Fukuura, Kanazawa-ku, 236-0004 Yokohama
Tel
045-370-7627
m_abe@yokohama-cu.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
| 2019 | Year | 11 | Month | 11 | 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
34
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 05 | 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
None
Management information
Registered date
| 2019 | Year | 11 | Month | 11 | Day |
Last modified on
| 2024 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043919
