UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028690 |
|---|---|
| Receipt number | R000032820 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2017/08/21 |
| Last modified on | 2017/08/16 18:17:07 |
* 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
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
Acronym
Development of a support program to enhance competency
Scientific Title
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
Scientific Title:Acronym
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
| 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
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
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
Other
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
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 |
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
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032820
