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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034276
Receipt No. R000039072
Official scientific title of the study 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 2018/09/26

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Basic information
Official scientific title of the study Effects of sedentary behaviour and physical inactivity on mental health and depression biomarkers in older adults
Title of the study (Brief title) 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 MASAKI TAKAHASHI
Organization Waseda University
Division name Organization for University Research Initiatives
Address 2-2 Wakamatsu-cho, Shinjuku, Tokyo, 162-8480, Japan
TEL 81353697318
Email m-takahashi@aoni.waseda.jp

Public contact
Name of contact person MASAKI TAKAHASHI
Organization Waseda University
Division name Organization for University Research Initiatives
Address 2-2 Wakamatsu-cho, Shinjuku, Tokyo, 162-8480, Japan
TEL 81353697318
Homepage URL
Email m-takahashi@aoni.waseda.jp

Sponsor
Institute Waseda University
Institute
Department

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 02 Month 23 Day
Anticipated trial start date
2015 Year 03 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 09 Month 26 Day
Last modified on
2018 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039072

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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