UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000055297
Receipt number R000060395
Scientific Title Feedback system validation
Date of disclosure of the study information 2024/08/21
Last modified on 2025/02/20 09:01:51

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Basic information

Public title

Effect on professional exercise program implementation time by intervention of feedback for workers

Acronym

Feedback system validation

Scientific Title

Feedback system validation

Scientific Title:Acronym

Feedback system validation

Region

Japan


Condition

Condition

worker

Classification by specialty

Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify whether a unique feedback system can affect exercise habits

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Exercise practice record

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Distribution of feedback sheets for exercise implementation

Interventions/Control_2

Exercise only

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Those who can participate in a total of 36 or more training sessions (more than 3 times/week)
2) Workers aged 20 to 75 (age at time of test registration)
3) Those who personally own a smartphone and can freely watch YouTube at their own discretion (regardless of location, time, etc.)

Key exclusion criteria

1) Persons who cannot walk independently and whose activities of daily living are restricted by a doctor (e.g., wheelchair users, crutch users due to bone fractures, etc.)

Target sample size

150


Research contact person

Name of lead principal investigator

1st name yasuhiro
Middle name
Last name suzuki

Organization

University of Tsukuba

Division name

Information Systems

Zip code

305-8573

Address

1-1-1 Tennodai, Tsukuba City, Ibaraki Prefecture

TEL

0298536181

Email

minaminagasaki2007@yahoo.co.jp


Public contact

Name of contact person

1st name yasuhiro
Middle name
Last name suzuki

Organization

University of Tsukuba

Division name

Information Systems

Zip code

3058573

Address

1-1-1 Tennodai, Tsukuba City, Ibaraki Prefecture

TEL

0295836181

Homepage URL


Email

minaminagasaki2007@yahoo.co.jp


Sponsor or person

Institute

Jichi Medical University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Jichi Medical University

Address

3311-1 Yakushiji, Shimotsuke City, Tochigi Prefecture, 329-0498

Tel

0298536181

Email

minaminagasaki2007@yahoo.co.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

2024 Year 08 Month 21 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

2024 Year 08 Month 20 Day

Date of IRB

2024 Year 08 Month 20 Day

Anticipated trial start date

2024 Year 08 Month 21 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2024 Year 08 Month 21 Day

Last modified on

2025 Year 02 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060395