UMIN-CTR Clinical Trial

Basic information
Public title	Blended health promotion centered on remote exercise classes with preventive measures against Covid-19 infection.
Acronym	Blended health promotion centered on remote exercise classes with preventive measures against Covid-19 infection.
Scientific Title	Blended health promotion centered on remote exercise classes with preventive measures against Covid-19 infection.
Scientific Title:Acronym	Blended health promotion centered on remote exercise classes with preventive measures against Covid-19 infection.
Region	Japan

Condition
Condition	Healthy person
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effectiveness of maintaining and recovering physical strength, and of improving QOL by providing blended health promotion program with preventive measures against Covid-19 infection for residents who are worried about their decreased physical strength due to reduced opportunities to exercise.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Physical fitness test(according to the endpoints of Jikinjuba Exercise which is advocated by Tenri University Physical Fitness Laboratory)
Key secondary outcomes

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	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Participants will be provided a 90-minute weekly remote exercise program for 6 months.
Interventions/Control_2	Additionaly half of the participants will be made to walk at a medium pace(3.5METs) for 20-30 minutes 2-3 times a week.
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Those who declined their physical strength by physical fitness test in 2019 due to reduced opportunities to exercise.
Key exclusion criteria	1 Those who took other health promotion programs. 2 Those who are forbidden to exercise by a doctor.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Etsuko Middle name Last name Tanaka
Organization	Social medical corporation Heiwakai Yoshida Hospital
Division name	Corporate Secretariat Organization Division
Zip code	631-0818
Address	1-7-1, Saidaiji Akodacho, Nara City, Nara Prefecture
TEL	0742-45-4601
Email	soshiki@heiwakai.or.jp

Public contact
Name of contact person	1st name Shunji Middle name Last name Mori
Organization	Social medical corporation Heiwakai Yoshida Hospital
Division name	Corporate Secretariat Organization Division
Zip code	631-0818
Address	1-7-1, Saidaiji Akodacho, Nara City, Nara Prefecture
TEL	0742-45-4707
Homepage URL
Email	mori@heiwakai.or.jp

Sponsor
Institute	Social medical corporation Heiwakai
Institute
Department

Funding Source
Organization	Japan Network of Health Promoting Hospitals and Health Services Secretariat
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	Yoshida Hospital Ethics Committee
Address	1-7-1, Saidaiji Akodacho, Nara City, Nara Prefecture
Tel	0742-45-4601
Email	byouinkannri@heiwakai.or.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	2021 Year 10 Month 01 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	2021 Year 09 Month 30 Day
Date of IRB	2020 Year 12 Month 07 Day
Anticipated trial start date	2021 Year 09 Month 30 Day
Last follow-up date	2022 Year 05 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 08 Month 06 Day
Last modified on	2022 Year 08 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051481