UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053624 |
|---|---|
| Receipt number | R000061197 |
| Scientific Title | Effect of a Physical Activity Self-Monitoring Intervention on Physical Activity and Health-Related Quality of Life for Day Care Center Users, non-randomized controlled trial |
| Date of disclosure of the study information | 2024/02/15 |
| Last modified on | 2024/02/15 15:33:25 |
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Basic information
Public title
Effect of a Physical Activity Self-Monitoring Intervention on Physical Activity and Health-Related Quality of Life for Day Care Center Users
Acronym
Effect of a PA Self-Monitoring Intervention on PA and HRQOL for Day Care Center Users
Scientific Title
Effect of a Physical Activity Self-Monitoring Intervention on Physical Activity and Health-Related Quality of Life for Day Care Center Users, non-randomized controlled trial
Scientific Title:Acronym
Effect of a PA Self-Monitoring Intervention on PA and HRQOL for Day Care Center Users, non-randomized controlled trial
Region
| Japan |
Condition
Condition
Daycare center users; older people with the long-term care insurance, etc
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective was to investigate the impact of a self-monitoring intervention to promote physical activity on physical activity and health-related quality of life in a non-randomized controlled trial among users of daycare center.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Steps and sedentary behavior (baseline to 12-week follow-up)
Key secondary outcomes
Health-related quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
Intervention group:Self-monitoring for physical activity promotion
Interventions/Control_2
Control group: Usual day care services
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
100
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
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
| 2024 | Year | 02 | Month | 15 | 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
100
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 15 | Day |
Last modified on
| 2024 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061197
