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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042340
Receipt No. R000048260
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.
Date of disclosure of the study information 2020/11/04
Last modified on 2020/11/04

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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