UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052593 |
|---|---|
| Receipt number | R000060017 |
| Scientific Title | A randomized controlled trial of Exercise and Protein Intake for the Elderly Living in the Community Including Working Elderly for the Improvement of Frailty |
| Date of disclosure of the study information | 2023/10/26 |
| Last modified on | 2024/07/02 12:31:31 |
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Basic information
Public title
A randomized controlled trial of Exercise and Protein Intake for the Elderly Living in the Community Including Working Elderly for the Improvement of Frailty
Acronym
Exercise and Nutritional Support Intervention Trials Inclusive of Working Older Adults
Scientific Title
A randomized controlled trial of Exercise and Protein Intake for the Elderly Living in the Community Including Working Elderly for the Improvement of Frailty
Scientific Title:Acronym
Exercise and Nutritional Support Intervention Trials Inclusive of Working Older Adults
Region
| Japan |
Condition
Condition
Frail or Pre-frail elderly adults (60years old or more)
Classification by specialty
| Orthopedics | Rehabilitation medicine |
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 frailty among the elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Weight loss, walking speed, grip strength, exhaustion, exercise habits, Kihon checklist
Key secondary outcomes
Frailty-related items: oral function, gait, posture, general cognitive function, motor function test, body composition, employment status, work motivation, subjective health perspective, nutrition intake, food diversity score, sleep status, biochemical data (AST, ALT, gamma-GT, uric acid, albumin, triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, blood glucose, HbA1c, creatine kinase, urea nitrogen, creatinine, CRP, calcium, inorganic phosphorus, P1NP, NTx), physical activity, depression, life spread, basic checklist, flexibility
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
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
| Food | Other |
Interventions/Control_1
Intervention group: Perform original community-based exercise program for 10 sessions over 3 months. In addition, only the intervention group will receive 20 g/day of a powder containing soy protein for 3 months. On days when there is no in-person exercise program, both groups will have an on-demand delivered exercise program.
Interventions/Control_2
Active Control group: Original community-based exercise program for the elderly should be performed in 10 sessions over 3 months. On days when there is no in-person exercise program, both groups will have an on-demand delivered exercise program.
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
80
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Imaoka |
Organization
Osaka Kawasaki Rehabilitation University
Division name
Department of Rehabilitation
Zip code
5970104
Address
Mizuma158 Kaizuka city, Osaka
TEL
07244466700
imaokamasakazu@gmail.com
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Imaoka |
Organization
Osaka Kawasaki Rehabilitation University
Division name
Department of Rehabilitation
Zip code
5970104
Address
Mizuma158 Kaizuka city, Osaka
TEL
07244466700
Homepage URL
imaokamasakazu@gmail.com
Sponsor or person
Institute
Osaka Kawasaki Rehabilitation University
Institute
Department
Personal name
Funding Source
Organization
FUJI OIL CO.,LTD
Fuji Oil Group Holdings, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
FUJI OIL CO., LTD
Fuji Oil Group Holdings, Ltd.
Nara Women's University
Section of elder care, Kaizuka City
Name of secondary funder(s)
Grant-in-Aid for Early-Career Scientists 23K16367
IRB Contact (For public release)
Organization
Osaka Kawasaki Rehabilitation University
Address
Mizuma158, Kaizuka city, Osaka
Tel
07244466700
imaokamasakazu@gmail.com
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 | 10 | Month | 26 | 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 | 05 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2023 | Year | 10 | Month | 24 | Day |
Last modified on
| 2024 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060017
