UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041458 |
|---|---|
| Receipt number | 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 | 2023/08/22 16:31:36 |
* 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
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
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
kojima@opu.ac.jp
Sponsor or person
Institute
Okayama healthcare professional university
Institute
Department
Personal name
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
Okayama Healthcare Professional University
Address
3-2-18,Daiku,Kitaku,Okayama,Okayama
Tel
086-233-8020
somu@opu.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
| 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
25
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
We initially estimated the time of follow-up at about one year, but now that we have obtained data after three years, we would like to compile and publish the results together with the data after three years.
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 02 | Day |
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
Data collection in July 2022.
Management information
Registered date
| 2020 | Year | 08 | Month | 18 | Day |
Last modified on
| 2023 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.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 |
