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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034442
Receipt No. 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 2019/04/12

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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
Email 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
Email reha@ctmc.jp

Sponsor
Institute Shonan Fujisawa Tokusyukai Hospital
Institute
Department

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
Email hamade@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
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
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
2019 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039273

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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