UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037898 |
|---|---|
| Receipt number | R000043201 |
| Scientific Title | Effects of Fujisawa Plus Ten exercise program |
| Date of disclosure of the study information | 2019/09/03 |
| Last modified on | 2023/03/09 14:57:56 |
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Basic information
Public title
physical, mental, and social health effects of Fujisawa Plus Ten exercise program
Acronym
Effects of a low-intensity and short-time exercise program in community-dwelling elderly: a non-randomized controlled trial
Scientific Title
Effects of Fujisawa Plus Ten exercise program
Scientific Title:Acronym
Effects of a low-intensity and short-time exercise program: a non-randomized controlled trial
Region
| Japan |
Condition
Condition
locomotive syndrome
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects of a low-intensity, short-time exercise program: Fujisawa Plus Ten exercise program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
2 step test
Key secondary outcomes
Frailty, Grip strenght, Gait speed, One leg standing test, CS-30 test, body composition, physical activity, cognitive function (CADi2), K-6 Japanese version, EQ-5D, WHO-5, subjective health, loco-check, pain, well-being, apathy, social capital
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Perform Fujisawa Plus Ten exercise at least once a week for groups and once a day for individuals for 10 weeks.
Interventions/Control_2
Normal group activities and life
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
Those who can come to the place of group activities
Key exclusion criteria
Persons who have difficulty in exercise due to illness, persons with mental illness or dementia
Target sample size
468
Research contact person
Name of lead principal investigator
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Saito |
Organization
Keio University
Division name
Graduate School of Health Management
Zip code
2238521
Address
Sports Medicine Research Center, Keio University, 4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa, Japan
TEL
045-566-0190
y.saito@keio.jp
Public contact
Name of contact person
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Saito |
Organization
Keio University
Division name
Graduate School of Health Management
Zip code
2238521
Address
Sports Medicine Research Center, Keio University, 4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa, Ja
TEL
045-566-0190
Homepage URL
y.saito@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University Graduate School of Health Management, Research Ethics Committee
Address
4411 Endo, Fujisawa, Kanagawa, Japan
Tel
0466-49-6200
nmc-hm@adst.keio.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
| 2019 | Year | 09 | Month | 03 | Day |
Related information
URL releasing protocol
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-18K11055/
Publication of results
Partially published
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-18K11055/
Number of participants that the trial has enrolled
44
Results
the two-step value was significantly improved in the intervention group with a mean change (standard deviation) of 0.04 (0.07) from the baseline evaluation to the 10-week evaluation (p = 0.04). On the other hand, the change in the control group was 0.01 (0.11), which was not significantly different.
Results date posted
| 2023 | Year | 03 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean (standard deviation) age of the participants was 78.4 (4.9) years for the intervention group and 76.5 (3.0) years for the control group, with 8 (61.5%) and 9 (52.9%) being female, respectively.
Participant flow
The 22 members of Club A who applied for the study were selected as the Fujisawa Plus Ten Exercise group (intervention group), and the 22 members of Club B were selected as the non-intervention group (control group).
Adverse events
None.
Outcome measures
Primary outcome: 2-step value (maximum 2 strides divided by height); secondary outcomes: grip strength, 30-second chair rise test, walking speed, open-eyed one-leg stand
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 29 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 02 | Day |
Last modified on
| 2023 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043201
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