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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000036652
Receipt No. R000041756
Scientific Title Effects of different kinds of lower intensity activities engaging in the evening on objective sleep composition in older adults. -focused on exercise and household chores-
Date of disclosure of the study information 2019/05/30
Last modified on 2019/05/07

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Basic information
Public title Effects of different kinds of lower intensity activities engaging in the evening on sleep in older adults.
Acronym Effects of lower intensity exercise in the evening on sleep
Scientific Title Effects of different kinds of lower intensity activities engaging in the evening on objective sleep composition in older adults. -focused on exercise and household chores-
Scientific Title:Acronym Effects of lower intensity exercise in the evening on sleep
Region
Japan

Condition
Condition Older adults (65-79 years)
Classification by specialty
Endocrinology and Metabolism Geriatrics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of different kinds of lower intensity activities in the evening on sleep quality.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Polysomnography (Sleep latency, sleep architecture)
Subjective sleep quality questionnaire (OSA sleep inventory MA version)
Key secondary outcomes Body core temperature (Rectal temperature)
Metabolism (Total energy expenditrue)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 6
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 The lower intensity of exercise (30min) - household chores (30min) - sitting position
Interventions/Control_2 The lower intensity of exercise (30min) - sitting position - household chores (30min)
Interventions/Control_3 The lower intensity of household chores (30min) - exercise (30min) - sitting position
Interventions/Control_4 The lower intensity of household chores (30min) - sitting position - exercise (30min)
Interventions/Control_5 Sitting position - the lower intensity of exercise (30min) - household chores (30min)
Interventions/Control_6 Sitting position - the lower intensity of household chores (30min) - exercise (30min)
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit
79 years-old >=
Gender Female
Key inclusion criteria Aged 65 to 79 years.
Who are not prohibited from exercising by a doctor.
No take sleeping pills.
Free of the medical history of sleep apnea syndrome.
Free of the medical history of diabetes.
Habitual Exercise less than 2 times in a week.
Key exclusion criteria Who certified as long-term care insurance.
Free of the medical history of serious disease, cerebrovascular disease, and paralysis.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Tomohiro
Middle name
Last name Okura
Organization University of Tsukuba
Division name Faculty of Health and Sport Sciences
Zip code 305-8575
Address 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, JAPAN
TEL 029-853-2733
Email okura.tomohiro.gp@u.tsukuba.ac.jp

Public contact
Name of contact person
1st name Jaehoon
Middle name
Last name Seol
Organization University of Tsukuba
Division name Doctoral Program in Physical Education, Health and Sport Sciences
Zip code 305-8575
Address 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, JAPAN
TEL 029-853-3639
Homepage URL
Email s1730502@s.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Physical Fitness Research Institute, Meiji Yasuda Lie Foundation of Health and Welfare
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization University of Tsukuba
Address 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, JAPAN
Tel 029-853-2571
Email hitorinri@un.tsukuba.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 筑波大学(茨城県)/ University of Tsukuba (Ibaraki, Japan)

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 30 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 Suspended
Date of protocol fixation
2018 Year 10 Month 17 Day
Date of IRB
2019 Year 02 Month 27 Day
Anticipated trial start date
2019 Year 05 Month 30 Day
Last follow-up date
2019 Year 10 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
2019 Year 05 Month 05 Day
Last modified on
2019 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041756

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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