UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030404 |
|---|---|
| Receipt number | R000034718 |
| Scientific Title | A randomized controlled trial of multicomponent original community-based exercise program and nutrition support in older adults |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2023/10/24 11:38:17 |
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Basic information
Public title
A randomized controlled trial of multicomponent original community-based exercise program and nutrition support in older adults
Acronym
Original community-based exercise program and nutrition support study
Scientific Title
A randomized controlled trial of multicomponent original community-based exercise program and nutrition support in older adults
Scientific Title:Acronym
Original community-based exercise program and nutrition support study
Region
| Japan |
Condition
Condition
Healthy elderly adults (60years old or more)
Classification by specialty
| Neurology | Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of original community-based exercise program and nutritional support associated with the improvement of cognitive and physical functions among the elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
General cognitive function test
Body composition , Muscle mass,
Gait speed, Grip strength
Trail making test, and Working memory
Key secondary outcomes
Activities of daily living: Kihon checklist, Instrumental Activities of Daily Living (IADL)
Psychological function: Quality of Life (QOL), Geriatric Depression Scale (GDS), Life satisfaction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Intervention group: Perform original community-based exercise program for 10 sessions over 3 months. Intervention group should consume a peptide beverage (containing 4000 mg of soybean peptide) for 1 month over 3 months.
Interventions/Control_2
Control group: Original community-based exercise program for the elderly should be performed in 10 sessions over 3 months.
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
1) Elderly adults who have participated
in cohort studies, 2) Native speaker
3) No limitations on age, sex, and medications.
Key exclusion criteria
1)Doctors orders to stop exercise
2) Medically advised not to participate in exercise
3) Dementia
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Imaoka |
Organization
Osaka Kawasaki Rehabilitation University
Division name
Department of Rehabilitation
Zip code
Address
158 Mizuma, Kaizuka City, Osaka Prefecture
TEL
072-446-6700
imaokamasakazu@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masakazu Imaoka |
Organization
Osaka Kawasaki Rehabilitation University
Division name
Department of Rehabilitation
Zip code
Address
158 Mizuma, Kaizuka City, Osaka Prefecture
TEL
072-446-6700
Homepage URL
imaokamasakazu@gmail.com
Sponsor or person
Institute
Osaka Kawasaki Rehabilitation University
Institute
Department
Personal name
Funding Source
Organization
FUJI OIL CO.,LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
https://www.dovepress.com/articles.php?article_id=50396
Number of participants that the trial has enrolled
74
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
| 2018 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | 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
| 2017 | Year | 12 | Month | 15 | Day |
Last modified on
| 2023 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034718
