UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052044 |
|---|---|
| Receipt number | R000059401 |
| Scientific Title | Effects of self-monitoring using an accelerometer on physical activity of older adults with long-term care insurance: Randomized controlled trial, a pilot study |
| Date of disclosure of the study information | 2023/08/29 |
| Last modified on | 2023/08/29 17:41:02 |
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Basic information
Public title
Effects of self-monitoring using an accelerometer on physical activity of older adults with long-term care insurance
Acronym
Effects of self-monitoring on PA for older adults with LTCI
Scientific Title
Effects of self-monitoring using an accelerometer on physical activity of older adults with long-term care insurance: Randomized controlled trial, a pilot study
Scientific Title:Acronym
Effects of self-monitoring on PA for older adults with LTCI: a randomized controlled trial, pilot study
Region
| Japan |
Condition
Condition
Older adults with long-term care insurance
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the impact of a self-monitoring intervention to promote steps on physical activity such as steps in older adults with LTCI in a randomized controlled pilot study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Steps (baseline to 5-week follow-up)
Key secondary outcomes
sedentary behaviour, light activity level, moderate activity, vigorous activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Self-monitoring for physical activity promotion
Interventions/Control_2
Five week
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Able to walk with or without walking aids
Key exclusion criteria
Dementia (Mini Mental Status Examination score <24)
Those who cannot give consent to participate in the study
Those who have not used the center for more than 1 week or whose symptoms have worsened
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Kitamura |
Organization
Reiwa Health Sciences University
Division name
School of Physical Therapy, Faculty of Rehabilitation
Zip code
811-0213
Address
2-1-12 Wajirooka, Higashi-ku, Fukuoka
TEL
0926076701
pt_masa0808@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Kitamura |
Organization
Reiwa Health Sciences University
Division name
School of Physical Therapy, Faculty of Rehabilitation
Zip code
8110213
Address
2-1-12 Wajirooka, Higashi-ku, Fukuoka
TEL
0926076701
Homepage URL
pt_masa0808@yahoo.co.jp
Sponsor or person
Institute
Reiwa Health Sciences University
Institute
Department
Personal name
Masahiro Kitamura
Funding Source
Organization
Reiwa Health Sciences University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Reiwa Health Sciences University
Address
2-1-12 Wajirooka, Higashi-ku, Fukuoka
Tel
0926076701
pt_masa0808@yahoo.co.jp
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
| 2023 | Year | 08 | Month | 29 | 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
52
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
| 2022 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 29 | Day |
Last modified on
| 2023 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059401
