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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041458
Receipt No. R000047327
Scientific Title Research on the maintenance and improvement of physical and mental functions of elderly people under the self-restraint caused by COVID-19 by using a remote system to connect their homes
Date of disclosure of the study information 2020/10/01
Last modified on 2020/08/18

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Basic information
Public title Research on the maintenance and improvement of physical and mental functions of elderly people under the self-restraint caused by COVID-19 by using a remote system to connect their homes
Acronym Research to maintain and improve the mental and physical functions of the elderly using a remote system
Scientific Title Research on the maintenance and improvement of physical and mental functions of elderly people under the self-restraint caused by COVID-19 by using a remote system to connect their homes
Scientific Title:Acronym Research to maintain and improve the mental and physical functions of the elderly using a remote system
Region
Japan

Condition
Condition locomotive syndrome etc.
Classification by specialty
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will first objectively evaluate whether elderly people, who have been able to maintain their physical and mental functions by talking and exercising at local salons and other places of commuting, have suffered a decline in their physical and mental functions because they have been deprived of opportunities to go out. We will then evaluate the possibility of maintaining and improving their physical and mental functions through tele-rehabilitation using ICT and interactive communication with a large number of people at a distance, and evaluate its effectiveness in solving social problems.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measuring muscle strength by sit-to-stand test and balance ability by the one-leg standing time test before and at 3, 6 and 12 months after the intervention
Key secondary outcomes Assessment of Mental Functioning by the PGC Morale Scale Questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 In addition to the usual gymnastics salon, weekly online video calls will be used for simultaneous remote gymnastics and exercise instruction, as well as interactive communication through online meetings.
Interventions/Control_2 Only local voluntary gymnastics salons are available (large groups are not allowed during the period of self-restraint)
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 Men and women over 65 years of age who participate in a local gymnastics salon and are able to communicate with each other.
Key exclusion criteria People who have extreme difficulty with gymnastics and other physical activities, and people who are unable to communicate by online
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kazunori
Middle name
Last name Kojima
Organization Okayama healthcare professional university
Division name Department of Physical Therapy
Zip code 700-0913
Address 3-2-18,Daiku,Kitaku,Okayama
TEL 086-233-8020
Email kojima@opu.ac.jp

Public contact
Name of contact person
1st name Kazunori
Middle name
Last name Kojima
Organization Okayama healthcare professional university
Division name Department of Physical Therapy
Zip code 700-0913
Address 3-2-18,Daiku,Kitaku,Okayama
TEL 086-233-8020
Homepage URL
Email kojima@opu.ac.jp

Sponsor
Institute Okayama healthcare professional university
Institute
Department

Funding Source
Organization Okayama healthcare professional university
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization none
Address none
Tel none
Email none

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
2020 Year 10 Month 01 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 Preinitiation
Date of protocol fixation
2020 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2021 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 18 Day
Last modified on
2020 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047327

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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