UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042340 |
|---|---|
| Receipt number | 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 12:33:19 |
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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
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/
ishida.takashi.54x@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University School of Public Health
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048260
