UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045084 |
|---|---|
| Receipt number | R000051481 |
| Scientific Title | Blended health promotion centered on remote exercise classes with preventive measures against Covid-19 infection. |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2022/08/16 11:32:45 |
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Basic information
Public title
Blended health promotion centered on remote exercise classes with preventive measures against Covid-19 infection.
Acronym
Blended health promotion centered on remote exercise classes with preventive measures against Covid-19 infection.
Scientific Title
Blended health promotion centered on remote exercise classes with preventive measures against Covid-19 infection.
Scientific Title:Acronym
Blended health promotion centered on remote exercise classes with preventive measures against Covid-19 infection.
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of maintaining and recovering physical strength, and of improving QOL by providing blended health promotion program with preventive measures against Covid-19 infection for residents who are worried about their decreased physical strength due to reduced opportunities to exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical fitness test(according to the endpoints of Jikinjuba Exercise which is advocated by Tenri University Physical Fitness Laboratory)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants will be provided a 90-minute weekly remote exercise program for 6 months.
Interventions/Control_2
Additionaly half of the participants will be made to walk at a medium pace(3.5METs) for 20-30 minutes 2-3 times a week.
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
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who declined their physical strength by physical fitness test in 2019 due to reduced opportunities to exercise.
Key exclusion criteria
1 Those who took other health promotion programs.
2 Those who are forbidden to exercise by a doctor.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Etsuko |
| Middle name | |
| Last name | Tanaka |
Organization
Social medical corporation Heiwakai Yoshida Hospital
Division name
Corporate Secretariat Organization Division
Zip code
631-0818
Address
1-7-1, Saidaiji Akodacho, Nara City, Nara Prefecture
TEL
0742-45-4601
soshiki@heiwakai.or.jp
Public contact
Name of contact person
| 1st name | Shunji |
| Middle name | |
| Last name | Mori |
Organization
Social medical corporation Heiwakai Yoshida Hospital
Division name
Corporate Secretariat Organization Division
Zip code
631-0818
Address
1-7-1, Saidaiji Akodacho, Nara City, Nara Prefecture
TEL
0742-45-4707
Homepage URL
mori@heiwakai.or.jp
Sponsor or person
Institute
Social medical corporation Heiwakai
Institute
Department
Personal name
Funding Source
Organization
Japan Network of Health Promoting Hospitals and Health Services Secretariat
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
Yoshida Hospital Ethics Committee
Address
1-7-1, Saidaiji Akodacho, Nara City, Nara Prefecture
Tel
0742-45-4601
byouinkannri@heiwakai.or.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
| 2021 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 06 | Day |
Last modified on
| 2022 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051481
