UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044359 |
|---|---|
| Receipt number | R000050660 |
| Scientific Title | Study on the effects of exercise programs for older adults with frail and frail risk |
| Date of disclosure of the study information | 2021/05/28 |
| Last modified on | 2021/05/28 14:54:21 |
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Basic information
Public title
Study on the effects of exercise programs for older adults with frail and frail risk
Acronym
Study on the effects of exercise programs for older adults with frail and frail risk
Scientific Title
Study on the effects of exercise programs for older adults with frail and frail risk
Scientific Title:Acronym
Study on the effects of exercise programs for older adults with frail and frail risk
Region
| Japan |
Condition
Condition
frail
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of physical exercise for older adults with frailty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL score
Key secondary outcomes
Frail status,Physical function (grip strength, leg strength, gait speed, Short Physical Performance Battery (SPPB), Muscle mass (BIA), Cerebral blood flow, Bone density, Cognitive function, Psychological indicators,
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: group-based exercise program
Interventions/Control_2
Control group: Individual exercise
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Older people at high risk of needing long-term care
2.Give a written informed consent to the participation in the present study
3. Willingness to continue exercising
Key exclusion criteria
1.Have serious or unstable illnesses
2.Suspected of severe dementia
3.Have a problem in the safe implementation of exercise
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hyuma |
| Middle name | |
| Last name | Makizako |
Organization
Kagoshima University
Division name
Department of Physical Therapy, School of Health Sciences, Faculty of Medicine
Zip code
890-8544
Address
8-35-1 Sakuragaoka, Kagoshima-city, Kagoshima 890-8544, Japan
TEL
099-275-6775
makizako@health.nop.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Mana |
| Middle name | |
| Last name | Tateishi |
Organization
Kagoshima University
Division name
Department of Physical Therapy, School of Health Sciences, Faculty of Medicine
Zip code
890-8544
Address
8-35-1 Sakuragaoka, Kagoshima-city, Kagoshima 890-8544,Japan
TEL
099-275-6175
Homepage URL
m-tateishi@health.nop.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Kagoshima University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kagoshima Medical Professional College
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima Medical Professional College
Address
5417-1 Utsuguchi, Hirakawa-cho, Kagoshima-city, Kagoshima 891-0133 Japan
Tel
099-261-6161
pt.taniguchi@harada-gakuen.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
| 2021 | Year | 05 | Month | 28 | 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
31
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
| 2020 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 27 | 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 | 05 | Month | 28 | Day |
Last modified on
| 2021 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050660
| 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 |
