UMIN-CTR Clinical Trial

Basic information
Public title	Effects of different of exercise intensity engaging in the evening on sleep in older adults.
Acronym	Effects of different of exercise intensity on sleep in older adults.
Scientific Title	Effects of different of exercise intensity engaging in the evening on sleep in older adults with insomnia.
Scientific Title:Acronym	Effects of exercise intensity engaging in the evening on sleep in older adults with insomnia.
Region	Japan

Condition
Condition	Older adults (65-79 years)
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of different of exercise intensity 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	Objective sleep parameters (actigraph) Subjective sleep parameters (questionnaire, sleep dairy) on during the intervention period
Key secondary outcomes	Intensity of physical activity on during the intervention period

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	In evening (after pm18:00), about 30 minutes of low-intensity exercise for twelve weeks.
Interventions/Control_2	In evening (after pm18:00), about 30 minutes of moderate to vigorous intensity exercise for twelve weeks.
Interventions/Control_3	No interventional for twelve weeks.
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	79 years-old >=
Gender	Male and Female
Key inclusion criteria	Aged 65 to 79 years. Who are not prohibited from exercising by a doctor. No take sleeping pills. Free of medical history of sleep apnea syndrome. No clinical research participation over the past year. Free of medical history of diabetes. Habitual Exercise less than 2 times in week.
Key exclusion criteria	Who certified as long-term care insurance. Free of medical history of serious disease, cerebrovascular disease and paralysis. Total score of PSQI 5<=
Target sample size	60

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	305-8574
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	029-853-2639
Homepage URL
Email	s1730502@s.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	University of Tsukuba
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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	2020 Year 06 Month 10 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	60
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	Completed
Date of protocol fixation	2019 Year 11 Month 01 Day
Date of IRB	2019 Year 12 Month 10 Day
Anticipated trial start date	2020 Year 05 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 04 Month 13 Day
Last modified on	2021 Year 10 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045217