UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034442 |
|---|---|
| Receipt number | R000039273 |
| Scientific Title | Research on searching for the amount of physical activity before and after discharge in elderly patients admitted to acute hospital |
| Date of disclosure of the study information | 2018/10/11 |
| Last modified on | 2023/01/21 11:00:27 |
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Basic information
Public title
Research on searching for the amount of physical activity before and after discharge in elderly patients admitted to acute hospital
Acronym
Research on searching for the amount of physical activity before and after discharge in elderly patients admitted to acute hospital
Scientific Title
Research on searching for the amount of physical activity before and after discharge in elderly patients admitted to acute hospital
Scientific Title:Acronym
Research on searching for the amount of physical activity before and after discharge in elderly patients admitted to acute hospital
Region
| Japan |
Condition
Condition
Disease of internal medicine
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Nephrology | Clinical immunology | Infectious disease |
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the amount of PA and the amount of change in the hospital phase of an elderly patient admitted to acute hospital and one month after discharge.
Basic objectives2
Others
Basic objectives -Others
Acute Phase Hospital Study the factors related to the amount of PA in the hospital phase of elderly patients admitted and one month after discharge.
To clarify the prognosis (death, re-hospitalization, falling, THE TOKYO METROPOLITAN INSTITUTE OF GERONTOLOGY INDEX ) three months after discharging of an elderly patient who is hospitalized for acute care.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acute hospital hospitalized hospitalized hospitalized hospital stay and physical activity amount after discharge and its amount of change
Key secondary outcomes
Physical activities in hospital phase and postdischarge and related indicators.
Relationship between Physical Activity Amount and Death After 3 Hours of Discharge, Falls, Presence of Re-Hospitalization and The tokyo metropolitan institute of gerontology index.
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 Acute disease or chronic disease Patients admitted to the department of internal medicine department due to acute exacerbations
2 Hospitalization At least 65 years old
3 Patients with rehabilitation prescription during hospitalization
4 Patients who can evaluate gait (4 m autonomous or amenable to walk with surveillance)
5 After receiving sufficient explanation for the participation of this study, patients who obtained document consent by the patient's free will
Key exclusion criteria
1. Patients who underwent surgical treatment
2. Patients who need help to walk before hospitalization or who were unable to walk
3. Patients with motor function or sensory dysfunction that obviously affect walking
4. Patients with need for treatment or currently being treated
Five. Pacemaker implanted patients
6. Patients with diagnosis / history of dementia, higher brain dysfunction, depression
7. Patients who are difficult to investigate and measure each indicator described below due to a medical condition etc.
8. Patients who are difficult to discharge from home
9. In addition, patients whose research managers judged inappropriate as research subjects
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Kobayashi |
Organization
Shonan Fujisawa Tokusyukai Hospital
Division name
Department of Rehabilitation
Zip code
251-0041
Address
1-5-1 Tsujido Shinto base in Fujisawa city, Kanagawa prefecture
TEL
0466-35-1177
reha@ctmc.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Kobayashi |
Organization
Shonan Fujisawa Tokusyukai Hospital
Division name
Department of Rehabilitation
Zip code
251-0041
Address
1-5-1 Tsujido Shinto base in Fujisawa city, Kanagawa prefecture
TEL
0466-35-1177
Homepage URL
reha@ctmc.jp
Sponsor or person
Institute
Shonan Fujisawa Tokusyukai Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Tokushukai Group Joint Ethics Review Committee
Address
1-chome, No. 8-7, Kojimachi, Chiyoda-ku, Tokyo
Tel
03-3263-4801
mirai-ec1@mirai-iryo.com
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
| 2018 | Year | 10 | Month | 11 | Day |
Related information
URL releasing protocol
https://mol.medicalonline.jp/library/journal/download?GoodsID=dq1careh/2021/002703/013&name=0254-025
Publication of results
Published
Result
URL related to results and publications
https://mol.medicalonline.jp/library/journal/download?GoodsID=dq1careh/2021/002703/013&name=0254-025
Number of participants that the trial has enrolled
81
Results
As a result of hierarchical multiple regression analysis, 5STS was extracted as a factor related to walking speed, and HADS-D was extracted along with grip strength.
When HADS-D was added to the model with background factors, 5STS, and grip strength as independent variables, a significant increase in the coefficient of determination was observed.
Results date posted
| 2023 | Year | 01 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
81 Elderly Cardiac Patients Aged 65 or Older (Mean Age 76.7 Years) who were Emergency Hospitalized for Heart Failure or Ischemic Heart Disease
Participant flow
Eighty-one elderly cardiac patients aged 65 years or older who were urgently hospitalized for heart failure or ischemic heart disease and did not meet the exclusion criteria were analyzed.
Adverse events
N/A
Outcome measures
Background factors, walking speed and 5times sit to stand test (5STS) assessed by Short Physical Performance Battery(SPPB), grip strength, depressive items on the hospital anxiety and depression scale (HADS-D)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research design: forward probing research
Recruitment method: A person who has been admitted to a research participation facility from November 21, 2017 to December 31, 2020, conforming to selection criteria.
Measurement items: patient background, physical activity amount, grip strength, Short Physical Performance Battery, Mini Mental State Examination, Frontal Assessment Battery, Hospital Anxiety and Depression Scale, Apathy scale, Arm muscle circumference Bioelectrical impedance analysis muscle mass, Baum test, IPAQ-E , Geriatric Nutritional Risk Index, death, falls, re-hospitalization, THE TOKYO METROPOLITAN INSTITUTE OF GERONTOLOGY INDEX
Management information
Registered date
| 2018 | Year | 10 | Month | 11 | Day |
Last modified on
| 2023 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039273
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