UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047669 |
|---|---|
| Receipt number | R000050669 |
| Scientific Title | Effects of exercise and nutritional guidance centered on telecommunication on the physical composition, muscle strength, and physical function in community dwelling older Japanese adults. |
| Date of disclosure of the study information | 2022/05/31 |
| Last modified on | 2022/05/06 17:32:48 |
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Basic information
Public title
Effects of exercise and nutritional guidance centered on telecommunication on the physical composition, muscle strength, and physical function in community dwelling older Japanese adults.
Acronym
Effects of exercise and nutritional guidance centered on telecommunication on the physical composition, muscle strength, and physical function in community dwelling older Japanese adults.
Scientific Title
Effects of exercise and nutritional guidance centered on telecommunication on the physical composition, muscle strength, and physical function in community dwelling older Japanese adults.
Scientific Title:Acronym
Effects of exercise and nutritional guidance centered on telecommunication on the physical composition, muscle strength, and physical function in community dwelling older Japanese adults.
Region
| Japan |
Condition
Condition
Men and women aged 65 years or older without a critical disease
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether long-term implementation of a frailty and sarcopenia prevention program using a remote assistance-focused method is as effective as a face-to-face program in community-dwelling Japanese older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skeletal muscle index, grip strength, walking speed, 5 times chair standing test speed, and sarcopenia prevalence 12 weeks after intervention
Key secondary outcomes
Body composition, blood pressure, physical activity, ADL, QOL, cognitive function, biochemical changes of blood, nutritional intake, eating habits
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
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Adults in the face-to-face guidance group performed 60 minutes face-to-face supervised resistance exercise once a week for the first 4 weeks plus similar exercise once a week at home, followed by 8 weeks of no face-to-face instruction and performed the same exercises twice a week at home while watching an instructional medium (DVD) for a total of 12 weeks. Nutritional guidance was provided once in person, followed by guidance over the telephone once a month, for a total of three sessions.
Interventions/Control_2
Adults in the remote guidance group performed the same exercises at home while watching an DVD twice a week and were provided nutritional guidance over the telephone once a month for a total of three times for 12 weeks. Body composition, muscle strength, and physical functions, such as five times sit-to-stand test, were examined before and after intervention.
Interventions/Control_3
Adults in the control group were only examined before and after intervention and did not undergo any intervention.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.community-dwelling people who are not hospitalized or resident of nursing home.
2.65 years old or older.
3.Be able to provide written informed consent.
Key exclusion criteria
Those who are mental illness, dementia, during dietary protein restriction due to renal failure or etcetera, to have difficulty walking, or judged to have difficulty performing exercise.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shiro |
| Middle name | |
| Last name | Izumi |
Organization
Tenshi College
Division name
School of Nursing and Nutrition
Zip code
0650013
Address
Higashi-ku, Kita-13 Higashi-3, Sapporo, Japan
TEL
011-741-1051
20182101@student.tenshi.ac.jp
Public contact
Name of contact person
| 1st name | Shiro |
| Middle name | |
| Last name | Izumi |
Organization
Tenshi College
Division name
School of Nursing and Nutrition
Zip code
0650013
Address
Higashi-ku, Kita-13 Higashi-3, Sapporo, Japan
TEL
011-741-1051
Homepage URL
20182101@student.tenshi.ac.jp
Sponsor or person
Institute
Tenshi College
Institute
Department
Personal name
Funding Source
Organization
Tenshi College
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tenshi College
Address
Higashi-ku, Kita-13 Higashi-3, Sapporo, Japan
Tel
011-741-1051
20182101@student.tenshi.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
天使大学（北海道） Tenshi College (Hokkaido)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 31 | 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
49
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
| 2020 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2022 | 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 | 05 | Month | 06 | Day |
Last modified on
| 2022 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050669
