UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of a support system based on promoting motivation for long-term exercise practice: Investigation effects of a support program to enhance competency related to exercise skills
Title of the study (Brief title)	Development of a support program to enhance competency
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 investigate the effect of a support program to enhance competency related to exercise skills on 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 two months
Key secondary outcomes	Changes of physical activity, body composition, body weight, cognitive function, autonomic neuron, assessment of motivation to exercise and profile of mood states for two 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	Motivation(competency) This exercise program is conducted with the support system promoting competency of intrinsic motivation Intervention period: 2 months Exercise program: 1 times/week, 90 min/session, total 8 sessions Exercise type: dual-task square step exercise
Interventions/Control_2	Control Intervention period: 2 months Exercise program: 1 times/week, 90 min/session, total 8 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	Kazunori Ohkawara
Organization	University of Electro-Communications
Division name	Graduate School of Informatics and Engineering
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	Kazunori Ohkawara
Organization	University of Electro-Communications
Division name	Graduate School of Informatics and Engineering
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
Institute	University of Electro-Communications
Institute
Department

Funding Source
Organization	University of Electro-Communications
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	National Institute of Informatics
Name of secondary funｄer(s)

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	2017 Year 08 Month 21 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 07 Month 01 Day
Anticipated trial start date	2017 Year 09 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 16 Day
Last modified on	2017 Year 08 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032820