UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048815 |
|---|---|
| Receipt number | R000055628 |
| Scientific Title | Effects of face-to-face and online group exercises on physical function among community-dwelling older adults |
| Date of disclosure of the study information | 2022/09/07 |
| Last modified on | 2023/03/04 22:54:02 |
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Basic information
Public title
Effects of face-to-face and online group exercises on physical function among community-dwelling older adults
Acronym
Effects of face-to-face and online group exercises on physical function among community-dwelling older adults
Scientific Title
Effects of face-to-face and online group exercises on physical function among community-dwelling older adults
Scientific Title:Acronym
Effects of face-to-face and online group exercises on physical function among community-dwelling older adults
Region
| Japan |
Condition
Condition
Community-dwelling older adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of face-to-face and online group exercises on the physical function of community-dwelling older adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Walking speed (12 weeks after the start of the intervention)
Key secondary outcomes
Extensor strength of knee joint extension, Velocity of knee joint extension, 2-step-test, Frequency of going out, The revised Japanese version of the Cardiovascular Health Study criteria, Self-efficacy for exercise, Physical activity
(12 weeks after the start of the intervention)
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
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Face-to-face group exercise (12 weeks, once every 2 weeks) and Home Exercise (12 weeks, every day to the extent possible)
Interventions/Control_2
Online group exercise (12 weeks, once every 2 weeks) and Home Exercise (12 weeks, every day to the extent possible)
Interventions/Control_3
No intervention
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Community-dwelling older adults who are able to walk and perform activities of daily living independently
Key exclusion criteria
Persons who are not able to walk independently, Persons with diseases affecting activities of daily living, Persons with moderate or severe respiratory or circulatory disease, Persons with dementia or other conditions that cause a significant decline in comprehension
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Iwata |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation
Zip code
583-8555
Address
3-7-30 Habikino, Habikino city, Osaka prefecture, Japan.
TEL
072-950-2111
iwata@omu.ac.jp
Public contact
Name of contact person
| 1st name | Tsubasa |
| Middle name | |
| Last name | Ito |
Organization
Osaka Prefecture University
Division name
Graduate School of Comprehensive Rehabilitation
Zip code
583-8555
Address
3-7-30 Habikino, Habikino city, Osaka prefecture, Japan.
TEL
072-950-2111
Homepage URL
itoresearch283@gmail.com
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
1. Self funding
2. Hankyu Hanshin Holdings, Inc.
3. IKIIKILIFE Hankyu Hanshin, Inc.
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
Committee on Research Ethics, The Graduate School of Rehabilitation, Osaka Metropolitan University
Address
3-7-30 Habikino, Habikino city, Osaka prefecture, Japan.
Tel
072-950-2111
yamamoto-reha@omu.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
| 2022 | Year | 09 | Month | 07 | 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
19
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
| 2022 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 01 | Day |
Last modified on
| 2023 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055628
