UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055310 |
|---|---|
| Receipt number | R000063123 |
| Scientific Title | Associated factors of social frailty and its impact on acute exacerbations in patients with chronic respiratory disease |
| Date of disclosure of the study information | 2024/08/23 |
| Last modified on | 2025/01/22 08:54:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Associated factors of social frailty and its impact on acute exacerbations in patients with chronic respiratory disease
Acronym
Social frailty in patients with chronic respiratory disease
Scientific Title
Associated factors of social frailty and its impact on acute exacerbations in patients with chronic respiratory disease
Scientific Title:Acronym
Social frailty in patients with chronic respiratory disease
Region
| Japan |
Condition
Condition
chronic respiratory disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate associated factors of social frailty and its impact on acute exacerbations in patients with chronic respiratory disease
Basic objectives2
Others
Basic objectives -Others
To investigate associated factors of social frailty and its impact on acute exacerbations.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Makizako's social frailty index (at study enrollment)
Key secondary outcomes
Acute exacerbation for 1-year from study enrollment.
Patient characteristics, long-term oxygen therapy, long-term care insurance, financial uneasiness, pulmonary functions, blood gases, physical functions, cognitive functions, muscle mass, activities of daily living, physical activity, dyspnea, health-related quality of life, and psychological conditions at study enrollment.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stable patients with chronic respiratory disese who can walk independently, and have given written informed consent.
Key exclusion criteria
Patients who: 1) have significant cognitive impairment that limits evaluations, 2) live in nursing-home, 3) have an acute exacerbation within 4-weeks prior to inclusion the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Shingai |
Organization
Nagasaki University Graduate School
Division name
Biomedical Sciences
Zip code
852-8520
Address
1-7-1, Sakamoto, Nagasaki, Japan
TEL
095-819-7963
k.shingai@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Shingai |
Organization
Kirigaoka Tsuda Hospital
Division name
Pulmonary Rehabilitation Center
Zip code
802-0052
Address
3-9-20, Kirigaoka, Kokurakita, Kitakyusyu, Fukuoka
TEL
093-921-0438
Homepage URL
k.shingai@hotmail.co.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University
Address
1-7-1, Sakamoto, Nagasaki, Japan
Tel
095-819-7198
gakujutu_gakuji@ml.nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
24071106
Org. issuing International ID_1
Nagaski University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
霧ヶ丘つだ病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 23 | 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
| 2024 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study deign: Prospective observational study
Participants: Patients followed at Kirigaoka Tsuda Hospital from August 2024 to March 2027 who meet the eligible criteria
Management information
Registered date
| 2024 | Year | 08 | Month | 22 | Day |
Last modified on
| 2025 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063123
