UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052140 |
|---|---|
| Receipt number | R000059510 |
| Scientific Title | Randomized controlled trial evaluating the effectiveness of soccer skills training in preventing frailty in older adults |
| Date of disclosure of the study information | 2023/09/15 |
| Last modified on | 2024/09/13 19:29:51 |
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Basic information
Public title
Randomized controlled trial evaluating the effectiveness of soccer skills training in preventing frailty in older adults
Acronym
Randomized controlled trial evaluating the effectiveness of soccer skills training in preventing frailty in older adults
Scientific Title
Randomized controlled trial evaluating the effectiveness of soccer skills training in preventing frailty in older adults
Scientific Title:Acronym
Randomized controlled trial evaluating the effectiveness of soccer skills training in preventing frailty in older adults
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to scientifically validate the effectiveness of soccer skills in preventing frailty in the elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effects on walking distance and speed, life satisfaction, happiness, and depressive tendencies among the elderly
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Implementation of the gymnastics program using soccer skills and soccer bowling for 30 minutes each.The gymnastics program consists of 10 minutes of lower body stretching, including hip and ankle, 10 minutes of leg strengthening, and 10 minutes of face-to-face passing.In the soccer bowling game, plastic bottles are used as pins, and the same thing as in the bowling game is done by kicking a soccer bowl with the feet. Participants are divided into teams and compete to win or lose.This program will be implemented once a week for five weeks.Weekly questionnaires and 10-meter walk time and step counts will be administered.
Interventions/Control_2
Questionnaires will be administered as well as 10-meter walk time and step counts at the 1st week and the 5th 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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elderly persons who were randomly selected from users of senior citizen activity facilities and who agreed to participate in the survey.
Key exclusion criteria
Those who are known to be unable to exercise according to a prior questionnaire.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Matsubara |
Organization
Waseda University
Division name
Faculty of Human Sciences
Zip code
3591192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6761
y-matsubara@waseda.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Matsubara |
Organization
Waseda University
Division name
Faculty of Human Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-6761
Homepage URL
y-matsubara@waseda.jp
Sponsor or person
Institute
Yumi Matsubara, Waseda University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University ethics review committee
Address
1-104 Totsukacho, Shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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
| 2023 | Year | 09 | Month | 15 | 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
| 2023 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 07 | 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
| 2023 | Year | 09 | Month | 07 | Day |
Last modified on
| 2024 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059510
