UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024372 |
|---|---|
| Receipt number | R000028056 |
| Scientific Title | Effects of vibrotactile feedback on sedentary behaviors: a pilot randomized controlled trial |
| Date of disclosure of the study information | 2016/10/12 |
| Last modified on | 2018/04/18 13:53:28 |
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Basic information
Public title
Effects of vibrotactile feedback on sedentary behaviors: a pilot randomized controlled trial
Acronym
Vibrotactile feedback to reduce sedentary behaviors
Scientific Title
Effects of vibrotactile feedback on sedentary behaviors: a pilot randomized controlled trial
Scientific Title:Acronym
Vibrotactile feedback to reduce sedentary behaviors
Region
| Japan |
Condition
Condition
Healthy but sedentary population
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether vibrotactile feedback can reduce sedentary time in previously sedentary adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sedentary time (change from baseline to the intervention period)
Key secondary outcomes
Changes from baseline to the intervention period for the following outcomes;
-Transitions from sitting/lying to standing
-Light-intensity physical activity
-Moderate-to-vigorous physical activity
-Step counts
Changes from baseline to week 8 for the following outcomes;
-Sedentary time
-Transitions from sitting/lying to standing
-Light-intensity physical activity
-Moderate-to-vigorous physical activity
-Step counts
-Body weight
-Abdominal visceral fat level
-Pulse wave velocity
-Central arterial pressure
-Vascular endothelial function
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
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Assessment of sedentary behavior plus feedback program using spontaneous vibration and a weekly report
Interventions/Control_2
Assessment of sedentary behavior 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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Self-reported sedentary time is 8 hours per day or longer
Key exclusion criteria
1. Pregnant or trying to get pregnant during the study period.
2. Irregular working conditions such as night/shift work.
3. Scheduled to disturb life rhythm such as an extended business trip during the study period.
4. Current participation or intention to participate in other clinical trials.
5. Considered ineligible judged by the principal investigator.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Maeda |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-8859
maeda@taiiku.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Sasai |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3076
Homepage URL
hiroyuki.sasai@gmail.com
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
筑波大学総合研究棟D
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 12 | 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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 12 | Day |
Last modified on
| 2018 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028056
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
