UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049591 |
|---|---|
| Receipt number | R000056472 |
| Scientific Title | A Double-Blind, Randomized, Placebo-controlled Trial on Prevention and Improvement of Physical Frailty in the Elderly by Continuous Exercise and Intake of Nutritional Foods |
| Date of disclosure of the study information | 2022/11/22 |
| Last modified on | 2023/06/21 11:28:34 |
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Basic information
Public title
Research on Prevention and Improvement of Physical Frailty in the Elderly by Continuous Exercise and Intake of Nutritional Foods
Acronym
The Effect of Exercise and Nutritional Foods on Prevention and Improvement of Physical Frailty
Scientific Title
A Double-Blind, Randomized, Placebo-controlled Trial on Prevention and Improvement of Physical Frailty in the Elderly by Continuous Exercise and Intake of Nutritional Foods
Scientific Title:Acronym
The Effect of Exercise and Nutritional Foods on Prevention and Improvement of Physical Frailty
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of 24 weeks of light exercise and nutritional food intake on physical frailty in the elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Walking speed
Key secondary outcomes
Frailty Check
Body composition
Grip strength
30-second chair standing test (CS-30)
Nutritional survey
Physical activity
Cognitive function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food | Other |
Interventions/Control_1
Intake of placebo foods for 24 weeks
Interventions/Control_2
Intake of nutritional foods for 24 weeks
Interventions/Control_3
Intake of placebo foods and exercise for 24 weeks
Interventions/Control_4
Intake of nutritional foods and exercise for 24 weeks
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) Men and women over 70 years old.
2) Those who are pre-frail or frail according to J-CHS criteria.
Key exclusion criteria
1) Patients who are currently in the hospital and have been restricted from exercising by their doctor, or who are unable to give their consent to participate in this study.
2) Patients who are judged to be unable to participate in the exercise intervention based on preliminary health status checks and preliminary examinations.
3) Those who are unable to give informed consent.
4) Those who exercise routinely.
5) Those who routinely consume medicines or health foods intended to improve motor function or muscle strength.
6) Those who take nutritional foods on a daily basis.
7) Those who are participating in other clinical trials.
8) Subjects who are allergic to foods.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Machida |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
270-1695
Address
1-1 Hirakagakuendai, Inzai, Chiba
TEL
0476-98-1001
machidas@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shuichi |
| Middle name | |
| Last name | Machida |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
270-1695
Address
1-1 Hirakagakuendai, Inzai, Chiba
TEL
0476-98-1001
Homepage URL
machidas@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Health and Sports Science
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Meiji Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee in Juntendo University Graduate School of Health and Sports Science
Address
1-1 Hirakagakuendai, Inzai, Chiba
Tel
0476-98-1001
sc-rinri@juntendo.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
| 2022 | Year | 11 | Month | 22 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 22 | Day |
Last modified on
| 2023 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056472
