UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044758 |
|---|---|
| Receipt number | R000051099 |
| Scientific Title | Effects of a web-based home exercise program on cognitive and physical functions in older adults: a randomized controlled trial |
| Date of disclosure of the study information | 2021/07/06 |
| Last modified on | 2024/01/09 10:48:39 |
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Basic information
Public title
Effects of a web-based home exercise program on cognitive and physical functions in older adults: a randomized controlled trial
Acronym
Effects of a web-based home exercise program on cognitive and physical functions in older adults: a randomized controlled trial
Scientific Title
Effects of a web-based home exercise program on cognitive and physical functions in older adults: a randomized controlled trial
Scientific Title:Acronym
Effects of a web-based home exercise program on cognitive and physical functions in older adults: a randomized controlled trial
Region
| Japan |
Condition
Condition
Maintaining and improving cognitive function
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the feasibility and effects of a web-based home exercise program for community-dwelling older adults on cognitive and physical functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function and mental health
Key secondary outcomes
Physical activity, physical function, and body composition
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
3-month web-based exercise program(20 min * 5 days / week)
Interventions/Control_2
No treatment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Independent community-dwelling older adults in Hachioji city
Key exclusion criteria
The person who:
1) is restricted by doctor from exercising.
2) is unable to exercise in a standing position.
3) has a history of stroke, dementia, or other serious illness.
4) take any tranquilizer or hormonal medication.
5) has systolic blood pressure at 160 mmHg or higher, or diastolic blood pressure at 95 mmHg or higher at rest.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Kai |
Organization
Meiji Yasuda Life foundation of health and welfare
Division name
Physical fitness research institute
Zip code
192-0001
Address
150, Tobuki-cho, Hachioji-city, Tokyo
TEL
042-691-1163
y-kai@my-zaidan.or.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Hyodo |
Organization
Meiji Yasuda Life foundation of health and welfare
Division name
Physical fitness research institute
Zip code
192-0001
Address
150, Tobuki-cho, Hachioji-city, Tokyo
TEL
042-691-1163
Homepage URL
k-hyodo@my-zaidan.or.jp
Sponsor or person
Institute
Meiji Yasuda Life foundation of health and welfare, Physical fitness research institute
Institute
Department
Personal name
Funding Source
Organization
Meiji Yasuda Life foundation of health and welfare, Physical fitness research institute
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiji Yasuda Life foundation of health and welfare
Address
150, Tobuki-cho, Hachioji-city, Tokyo
Tel
042-691-1163
yoshida@my-zaidan.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 | 07 | Month | 06 | 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
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | 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 | 07 | Month | 05 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051099
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
