UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045515 |
|---|---|
| Receipt number | R000051926 |
| Scientific Title | The Effect of Posture Patterns on Interruption of Sedentary Behaviors in Persons Requiring Nursing Care |
| Date of disclosure of the study information | 2021/09/19 |
| Last modified on | 2022/10/11 22:01:19 |
* 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
The Effect of Postural Differences on Interruption of Sedentary Behaviors in Persons Requiring Nursing Care
Acronym
The Effect of Postural Differences on Interruption of Sedentary Behaviors in Persons Requiring Nursing Care
Scientific Title
The Effect of Posture Patterns on Interruption of Sedentary Behaviors in Persons Requiring Nursing Care
Scientific Title:Acronym
The Effect of Posture Patterns on Interruption of Sedentary Behaviors in Persons Requiring Nursing Care
Region
| Japan |
Condition
Condition
Sarcopenia, frailty, bone fracture, dementia
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of differences in sitting posture on the number of interruptions and the duration of interruptions among the patterns of sitting behavior of persons requiring nursing care and persons requiring support who use day-care rehabilitation.
Basic objectives2
Others
Basic objectives -Others
Examination of new factors affecting the primary outcome
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sedentary behavior assessment
Key secondary outcomes
Physical Activity Time
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Elderly people aged 65 years or older who use day-care rehabilitation services who give consent to this study.
Those who do not require assistance for basic activities.
Key exclusion criteria
Patients with severe stroke, Parkinson's disease, or other neurological disorders
Those with a diagnosis of dementia
Those who are unable to communicate or read due to higher brain dysfunction or dementia.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Yamasaka |
Organization
Graduate School of Kio University
Division name
Health Sciences Research Section
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
TEL
080-4643-9777
kota.11.26.yamap@gmail.com
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Yamasaka |
Organization
Takata-Kamitani Hospital
Division name
rehabilitation department
Zip code
651-1421
Address
4-26-14, Kamiyamaguchi, Yamaguchi-cho, Nishinomiya City, Hyogo Pref
TEL
078-903-3333
Homepage URL
kota.11.26.yamap@gmail.com
Sponsor or person
Institute
Graduate School of Kio University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Kio University
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Kio University
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
Tel
0745-54-1601
kota.11.26.yamap@gmail.com
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
| 2021 | Year | 09 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Selection criteria: Consent for this study was obtained, and no assistance was required for basic activities.
Assessment of sedentary behavior: Using an accelerometer, the duration of sedentary behavior, physical activity time, interruption time, and number of interruptions are calculated.
Physical Activity Scale for the Elderly (PASE)
Seated posture assessment
Management information
Registered date
| 2021 | Year | 09 | Month | 18 | Day |
Last modified on
| 2022 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051926
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
