UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054479 |
|---|---|
| Receipt number | R000062227 |
| Scientific Title | Investigation of the relationship between physical activity and loneliness and isolation among university students. |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2025/01/22 10:33:46 |
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Basic information
Public title
Investigation of the relationship between physical activity and loneliness and isolation among university students.
Acronym
Investigation of the relationship between physical activity and loneliness and isolation among university students.
Scientific Title
Investigation of the relationship between physical activity and loneliness and isolation among university students.
Scientific Title:Acronym
The relationship between physical activity and loneliness and isolation.
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the hypothesis that there may be a relationship between loneliness/isolation and physical activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity, UCLA Loneliness Scale (Japanese)
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Students who belong to the Department of Health Sciences at Gunma University.
2) The participants must be able to spend their daily life wearing the activity meter during the measurement period.
3) Students who are studying at Gunma University during the measurement period.
Key exclusion criteria
1) Students who are not studying at Gunma University during the measurement period.
2) Those who are scheduled to study abroad or have off-campus training during the second measurement period.
3) The participant must have time to do activities without taking off the activity meter.
4) Those who will be engaged in an activity that will cause a severe shock to the activity tracker.
5) Persons who engage in activities that may cause the activity meter to get wet, submerge in water, or fall.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Daigo |
| Middle name | |
| Last name | Kato |
Organization
Gunma University, Graduate school of health sciences
Division name
Department of Rehabilitation sciences
Zip code
3718514
Address
3-39-22, Showa, Maebashi, Gunma, JAPAN
TEL
027-220-8971
dkato@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Daigo |
| Middle name | |
| Last name | Kato |
Organization
Gunma university, Graduateschool of health sciences
Division name
Department of Rehabilitation sciences
Zip code
3718514
Address
3-39-22, Showa, Maebashi, Gunma, JAPAN
TEL
027-220-8971
Homepage URL
dkato@gunma-u.ac.jp
Sponsor or person
Institute
Gunma university
Institute
Department
Personal name
Funding Source
Organization
Gunma Foundation for Medicine and Health Science
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
Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address
3-39-15, Showa, Maebashi, Gunma
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-u.ac.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 | 07 | Month | 01 | 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
| 2024 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
case series study
Management information
Registered date
| 2024 | Year | 05 | Month | 24 | Day |
Last modified on
| 2025 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062227
