UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020678
Receipt number R000023808
Scientific Title Development of a support system based on promoting motivation for long-term exercise practice: Comparison and integration intrinsic with extrinsic motivations
Date of disclosure of the study information 2016/02/01
Last modified on 2016/02/12 18:40:29

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Basic information

Public title

Development of a support system based on promoting motivation for long-term exercise practice: Comparison and integration intrinsic with extrinsic motivations

Acronym

Development of a support system for long-term exercise practice

Scientific Title

Development of a support system based on promoting motivation for long-term exercise practice: Comparison and integration intrinsic with extrinsic motivations

Scientific Title:Acronym

Development of a support system for long-term exercise practice

Region

Japan


Condition

Condition

Overweight

Classification by specialty

Medicine in general Endocrinology and Metabolism Surgery in general
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the effect between intrinsic and extrinsic motivations to long-term exercise practice

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

The change of daily step count for fifteen months

Key secondary outcomes

Changes of physical activity, body composition, body weight, cognitive function, assessment of motivation to exercise and profile of mood states for fifteen months


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Intrinsic motivation
This exercise program is conducted with the support system promoting intrinsic motivation
Intervention period: 3 months
Exercise program: 1 times/week, 90 min/session, total 12 sessions
Exercise type: dual-task square step exercise

Interventions/Control_2

Extrinsic motivation
This exercise program provides the achievement-based reward for subjects
Intervention period: 3 months
Exercise program: 1 times/week, 90 min/session, total 12 sessions
Exercise type: dual-task square step exercise

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

60 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Indivuduals who have no regular exercise (at least 30 minutes twice a week in one year)
2. Indivuduals who are not restricted to do exercise

Key exclusion criteria

1. Indivuduals who have current or past history of severe diseases
2. Individuals who are judged as unsuitable for the study by the investigator

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazunori Ohkawara

Organization

University of Electro-Communications

Division name

Graduate School of Informatics and Engineering

Zip code


Address

1-5-1 Chofugaoka, Chofu, Tokyo, 182-8585, Japan

TEL

042-443-5584

Email

ohkawara_kazunori@e-one.uec.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazunori Ohkawara

Organization

University of Electro-Communications

Division name

Graduate School of Informatics and Engineering

Zip code


Address

1-5-1 Chofugaoka, Chofu, Tokyo, 182-8585, Japan

TEL

042-443-5584

Homepage URL


Email

ohkawara_kazunori@e-one.uec.ac.jp


Sponsor or person

Institute

University of Electro-Communications

Institute

Department

Personal name



Funding Source

Organization

University of Electro-Communications

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

National Institute of Informatics

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

電気通信大学(東京都)


Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 01 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

Preinitiation

Date of protocol fixation

2015 Year 12 Month 10 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 15 Day

Last follow-up date

2017 Year 06 Month 30 Day

Date of closure to data entry

2017 Year 12 Month 30 Day

Date trial data considered complete

2018 Year 03 Month 30 Day

Date analysis concluded

2018 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2016 Year 01 Month 21 Day

Last modified on

2016 Year 02 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023808


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name