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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

Value
https://center6.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