UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051021 |
|---|---|
| Receipt number | R000058123 |
| Scientific Title | FRIENDLY (Frailty and Sarcopenia survey in Elderly) Study |
| Date of disclosure of the study information | 2023/05/09 |
| Last modified on | 2023/05/09 17:04:02 |
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Basic information
Public title
FRIENDLY (Frailty and Sarcopenia survey in Elderly) Study
Acronym
FRIENDLY (Frailty and Sarcopenia survey in Elderly) Study
Scientific Title
FRIENDLY (Frailty and Sarcopenia survey in Elderly) Study
Scientific Title:Acronym
FRIENDLY (Frailty and Sarcopenia survey in Elderly) Study
Region
| Japan |
Condition
Condition
Patients attending our medical center
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Japan is the world's largest super-aging society, with approximately 28% of the population aged 65 or older. The aging of the population has resulted in a prolonged period of bedridden patients and those requiring nursing care and other restrictions on daily living, which has led to a decline in the quality of life (QOL) of the patients themselves, a shortage of careworker, and an increase in medical costs. The Ministry of Health, Labour and Welfare (MHLW) has identified prevention of frailty and sarcopenia as a key measure to extend healthy life expectancy. Furthermore, from 2020, the prolonged global outbreak of COVID-19 infection limited the daily activities of the elderly, forcing them to restrict their exercise, and thus triggering the development of frailty and sarcopenia. Although the prevalence of frailty and sarcopenia among community-dwelling elderly in Japan has been reported, the prevalence of frailty and sarcopenia in outpatients, who often suffer from multiple diseases, is unknown.
Translated with www.DeepL.com/Translator (free version)
Basic objectives2
Others
Basic objectives -Others
We have been conducting an observational cohort study of frailty and sarcopenia in patients aged 65 years or older attending our medical center since 2021, and this time we planned a cross-sectional study on the prevalence of frailty and sarcopenia and related factors in patients attending departments other than internal medicine.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of flailty and sarcopenia
Key secondary outcomes
Examination of factors associated with frailty and sarcopenia
Analysis of the relationship between the assessment items (various questionnaires, blood tests, and muscle strength measurements) and each medical condition will also be conducted.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Regular outpatient at Juntendo Tokyo Koto Medical Center for the Elderly, Juntendo University School of Medicine
2 Age 65 or older
3 Independent walking (including walking with a cane)
4 Patients with consent to participate in the study
Key exclusion criteria
1 Patients who are unable to walk independently or who are unable to take a medical history/questionnaire
2 Patients with serious cerebrovascular, cardiac, respiratory, hepatic, renal, gastrointestinal, or endocrine-metabolic diseases
3 Patients whose life expectancy is judged to be within 1 year due to malignant diseases
4 Patients deemed ineligible by the attending physician
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Asaoka |
Organization
Juntendo Tokyo Koto Geriatric Medical Center
Division name
Department of Gastroenterology
Zip code
136-0075
Address
3-3-20, Shinsuna, Koto-ku, Tokyo
TEL
03-5632-3111
daisuke@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Matsuno |
Organization
Juntendo Tokyo Koto Geriatric Medical Center
Division name
Department of Respiratory Medicine
Zip code
136-0075
Address
3-3-20, Shinsuna, Koto-ku, Tokyo
TEL
03-5632-3111
Homepage URL
kmatsuno@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency (JST)
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
Juntendo Tokyo Koto Geriatric Medical Center Ethics Committee
Address
3-3-20 Shinsuna, Koto-ku, Tokyo
Tel
03-5632-3111
kmatsuno@juntendo.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
| 2023 | Year | 05 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 04 | 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
observational study
Management information
Registered date
| 2023 | Year | 05 | Month | 09 | Day |
Last modified on
| 2023 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058123
