UMIN-CTR Clinical Trial

Basic information
Public title	HOME FITNESS Project
Acronym	HFP
Scientific Title	A randomized controlled trial investigating the effectiveness of an exercise intervention program by an online remote gymnastics class to improve health and QOL(quality of life) for adults (men and women) between the ages of 20 and 60.
Scientific Title:Acronym	A randomized controlled trial investigating the effectiveness of exercise interventions by online gymnastics class to improve QOL(quality of life) for adults (men and women) between the ages of 20 and 60.
Region	Japan

Condition
Condition	None
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For Adults (men and women) between the ages of 20 and 60 who have no daily exercise habits who are forced to wait at home or work from home due to the spread of the coronavirus infection (COVID-19) , take an exercise intervention program by an online remote gymnastics classes useing the internet, and compare the exercise intervention group with the waiting list group to see if there is an increase in daily exercise intensity and quality of life (QOL) , the effect of the intervention.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase

Assessment
Primary outcomes	SF-12 (MOS 12-Item Short-Form Health Survey) Investigate "improvement of mental function" using "QOL summary score (MCS) of mental aspect".
Key secondary outcomes	1.SF-12 (MOS 12-Item Short-Form Health Survey) Investigate "improvement of physical function" using "QOL summary score (PCS) of physical aspect". 2.IPAQ short version, last 7 days (International standardized physical activity questionnaire) Survey on "daily activities". 3.PHQ-9 (questionnaire for mind and body) Survey on "mental health". 4.EQ-5D-5L Japanese version A survey on "maintaining mental function". 5.Simplified version of exercise habit promotion / inhibition factor scale: 20 questions Survey on "motivation to exercise". 6.Survey form on adverse events Survey on adverse events such as falls, falls, and the occurrence of acute low backs. 7.Overall questionnaire regarding research We asked them to describe the improvements, overall impressions, and free comments of this survey, and surveyed the satisfaction of the research subjects regarding the survey.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Exercise intervention group
Interventions/Control_2	Waiting group
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	20 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	1. Men and women between the ages of 20 and 60 who live in Japan. 2. Those who can access the specified URL using a PC, tablet, or smartphone and can watch LIVE video for exercise intervention. 3. Those who can participate 4 times without rest during this research period (1 month). 4. IPAQ (International Standardized Physical Activity Question) in the baseline survey Those who have less than 23 METs / hour / week of physical activity per week calculated from the "short version, last 7 days" of the vote). 5. In the baseline survey, SF-12's "Mental QOL Summer" Those who have a score of less than 50 points standardized by the national standard value of "Les Score (MCS)" or "Physical component summary (PCS)".
Key exclusion criteria	1. Those who have dementia or who have been diagnosed with dementia in the past. 2. Those who have a history of brain diseases such as cerebral infarction. 3. Those who have a history of heart disease such as heart disease. 4. Persons with a history of serious illness other than the above 5. Those who are out of the hospital due to the above-mentioned pre-existing conditions. 6. Those who are restricted from exercising by a doctor. 7. Studio Yogi students. 8. Those who have attended Studio Yogi. 9. Others who the researcher finds inappropriate
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Norio Middle name Last name Watanabe
Organization	Kyoto University
Division name	School of Public Health
Zip code	606-8507
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto
TEL	075-753-9491
Email	watanabe.norio.6x@kyoto-u.ac.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Ishida
Organization	Kyoto University
Division name	School of Public Health
Zip code	606-8507
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto
TEL	075-753-9491
Homepage URL	http://www.home-fitness.jp/
Email	ishida.takashi.54x@st.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University School of Public Health
Institute
Department

Funding Source
Organization	Self-procurement
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto University School of Public Health
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel	075-753-9491
Email	ishida.takashi.54x@st.kyoto-u.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	2020 Year 11 Month 04 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	Open public recruiting
Date of protocol fixation	2020 Year 10 Month 14 Day
Date of IRB	2020 Year 10 Month 15 Day
Anticipated trial start date	2020 Year 10 Month 30 Day
Last follow-up date	2021 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 11 Month 04 Day
Last modified on	2020 Year 11 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048260