UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034276 |
|---|---|
| Receipt number | R000039072 |
| Scientific Title | Effects of sedentary behaviour and physical inactivity on mental health and depression biomarkers in older adults |
| Date of disclosure of the study information | 2018/09/27 |
| Last modified on | 2021/07/06 11:27:07 |
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Basic information
Public title
Effects of sedentary behaviour and physical inactivity on mental health and depression biomarkers in older adults
Acronym
Physical activity and depression biomarkers
Scientific Title
Effects of sedentary behaviour and physical inactivity on mental health and depression biomarkers in older adults
Scientific Title:Acronym
Physical activity and depression biomarkers
Region
| Japan |
Condition
Condition
Elderly and depression
Classification by specialty
| Geriatrics | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of increased daily physical activity on depression biomarkers (i.e. BDNF and serotonin) as well as oxidative stress and antioxidant capacity in older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The findings may suggest that promotion of daily physical activity in older adults has a positive impact on depression without any change in oxidative stress.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Increased daily physical activity for 8 weeks
Interventions/Control_2
Remain daily physical activity for 8 weeks
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
Postmenopausal women aged 65-80 years old, no difficulties with mobility or performing activities of daily living
Key exclusion criteria
Those who are on medication, have been diagnosed with depression, diabetes (hyperglycaemia) and dyslipidaemia through medical examination, and those who had already participated in another research intervention program
Target sample size
39
Research contact person
Name of lead principal investigator
| 1st name | MASAKI |
| Middle name | |
| Last name | TAKAHASHI |
Organization
Tokyo Institute of Technology
Division name
Institute for Liberal Arts
Zip code
1528550
Address
Institute for Liberal Arts
TEL
+81-3-5734-2904
takahashi.m.bp@m.titech.ac.jp
Public contact
Name of contact person
| 1st name | MASAKI |
| Middle name | |
| Last name | TAKAHASHI |
Organization
Tokyo Institute of Technology
Division name
Institute for Liberal Arts
Zip code
1528550
Address
2-12-1, Ookayama Meguro-ku, Tokyo
TEL
+81-3-5734-2904
Homepage URL
takahashi.m.bp@m.titech.ac.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Young Scientists (B)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Waseda University
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University
Address
1-104, Totsukamachi, Shinjuku-ku, Tokyo
Tel
81352721639
rinri@list.waseda.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
| 2018 | Year | 09 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
38
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
Main results already published
Date of protocol fixation
| 2015 | Year | 02 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 26 | Day |
Last modified on
| 2021 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039072
