UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053056 |
|---|---|
| Receipt number | R000060535 |
| Scientific Title | Observational Study on the Relationship between Physical Activity, Physical Function, Higher Level Competence, and Social Networks after Discharge in Patients with Heart Failure |
| Date of disclosure of the study information | 2023/12/15 |
| Last modified on | 2023/12/11 14:18:37 |
* 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
Observational Study on the Relationship between Physical Activity, Physical Function, Higher Level Competence, and Social Networks after Discharge in Patients with Heart Failure
Acronym
Observational Study on the Relationship between Physical Activity, Physical Function, Higher Level Competence, and Social Networks after Discharge in Patients with Heart Failure
Scientific Title
Observational Study on the Relationship between Physical Activity, Physical Function, Higher Level Competence, and Social Networks after Discharge in Patients with Heart Failure
Scientific Title:Acronym
Observational Study on the Relationship between Physical Activity, Physical Function, Higher Level Competence, and Social Networks after Discharge in Patients with Heart Failure
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to illustrate the association between physical function, higher-level activity abilities, and social networks with the volume of physical activity throughout one-month post-discharge in patients admitted with decompensated heart failure, thereby highlighting the significance of higher-level competence and social network in the management of heart failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The physical activity measured using an accelerometer for one month after discharge.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Heart failure patients aged 65 years or older discharged from a hospital enrolled in the study site who have given consent for this study
Key exclusion criteria
Subjects with a decline in psychocognitive function that makes it difficult to understand the instructions for evaluation and fitting of measurement devices. Subjects with a cerebrovascular or orthopedic disease that makes it difficult to stand or walk. Subjects with a decline in ability to perform activities of daily living with a Berthel Index: BI score less than 85. Subjects who received treatment related to ischemic heart disease during hospitalization. Others whom the principal investigator judged to be inappropriate as subjects.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tetsuroh |
| Middle name | |
| Last name | Tamaru |
Organization
Shinshu University Graduate School
Division name
Graduate School of Medicine, Science and Technology, Department of Medical Sciences, Health Science Division
Zip code
3908621
Address
3-1 Asahi, Matsumoto City, Nagano Prefecture
TEL
0263-37-3376
20ms114h@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuroh |
| Middle name | |
| Last name | Tamaru |
Organization
Shinshu University Graduate School
Division name
Graduate School of Medicine, Science and Technology, Department of Medical Sciences, Health Science
Zip code
3908621
Address
3-1 Asahi, Matsumoto City, Nagano Prefecture
TEL
0263-37-3376
Homepage URL
20ms114h@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Graduate School
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagano Central Hospital, Nagano Municipal Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu university
Address
3-1 Asahi, Matsumoto City, Nagano Prefecture
Tel
0263-37-3376
mdrinri@shinshu-u.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 | 12 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient background includes age, gender, height, weight, and marital status. Vital signs include systolic blood pressure, diastolic blood pressure, and heart rate at the time of discharge from the hospital, blood chemistry tests including sodium, hemoglobin, creatinine, basal glomerular filtration rate, urea nitrogen, cerebral sodium peptide, and left ventricular ejection fraction on echocardiography. Blood biochemical tests include sodium, hemoglobin, creatinine, basal glomerular filtration rate, urea nitrogen, cerebral sodium peptide, left ventricular ejection fraction on echocardiography, and the use of ACE inhibitors, ARBs, beta blockers, MRAs, SGLT2 inhibitors, and ARNI as drug information. NYHA classification and heart failure stage classification will be evaluated as heart failure severity. Physical function will be assessed by 6-minute walk test, SPPB, and grip strength. Physical activity will be measured using active style pro (Omron Healthcare). The following data will be collected: 1) total number of steps per day (steps), 2) total activity (Mets*h), 3) daily activity (Mets*h), 4) walking activity (Mets*h), and 5) percentage of daily activity in the total activity. The Luben social network scale is used for social network. For higher activity capacity, we will use the Institute of Elderly Medicine's Activity Capacity Index and the JST version of the Activity Capacity Index.
Management information
Registered date
| 2023 | Year | 12 | Month | 11 | Day |
Last modified on
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060535
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
