UMIN-CTR Clinical Trial

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
Email	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
Email	20182101@student.tenshi.ac.jp

Sponsor
Institute	Tenshi College
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050669