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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031706
Receipt No. R000036212
Scientific Title Effects of different of exercise timing for improvement on sleep in older people.
Date of disclosure of the study information 2018/07/01
Last modified on 2020/05/05

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Basic information
Public title Effects of different of exercise timing for improvement on sleep in older people.
Acronym Effects of exercise timing on sleep in older people.
Scientific Title Effects of different of exercise timing for improvement on sleep in older people.
Scientific Title:Acronym Effects of exercise timing on sleep in older people.
Region
Japan

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

Objectives
Narrative objectives1 To examine an effective exercise (intensity and timing) for improvement on sleep in older people.
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 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 In morning (am 10-11), about 30 minutes of low-intensity exercise for eight weeks.
Interventions/Control_2 In evening (pm 18-19), about 30 minutes of low-intensity exercise for eight 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
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.
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@taiiku.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 305-8574
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 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 0298532571
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
2018 Year 07 Month 01 Day

Related information
URL releasing protocol https://journals.sagepub.com/home/jgp
Publication of results Unpublished

Result
URL related to results and publications https://journals.sagepub.com/home/jgp
Number of participants that the trial has enrolled 60
Results
In the evening exercise group, both subjectively and objectively measured sleep latency significantly improved throughout the intervention. Further, post-intervention subjective sleep satisfaction was significantly higher in the evening group than in the morning group. Additionally, sleep variables related to evening exercise had larger effect sizes (Cohens d) than those performed in the morning.
Results date posted
2020 Year 05 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants average of mean age was 70 years. More women than men participated. The mean PSQI global score was 7 points, with 66 percentage of participants scoring over 6 points indicating a poor sleeper. Adherence rates were similar across both groups. None of the measured variables differed significantly between the groups at baseline.
Participant flow
Initially, 105 older adults aged 65 to 79 volunteered for the study. We excluded people who already had a habit of exercising more than two days a week and who reported they were very satisfied with their sleep quality when they called by phone to confirm their participation. Of the remaining 76 people, 60 were randomly selected as participants by a blinded third researcher. Subjects were randomized into groups after the baseline measurements were collected. Participants were initially categorized as either 20 good or 40 poor sleepers before being randomly placed into the two groups based on a formula determined in Excel version 1902.
Adverse events
Three participants dropped out at baseline, six in morning exercise group, and two in evening exercise group. Attrition was due to personal reasons unrelated to the study.
Outcome measures
Objective (using actigraph) and subjective (sleep diary, PSQI) sleep quailty.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 01 Month 05 Day
Date of IRB
2018 Year 06 Month 05 Day
Anticipated trial start date
2018 Year 09 Month 10 Day
Last follow-up date
2018 Year 12 Month 16 Day
Date of closure to data entry
2019 Year 01 Month 15 Day
Date trial data considered complete
2019 Year 03 Month 20 Day
Date analysis concluded
2019 Year 05 Month 05 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 13 Day
Last modified on
2020 Year 05 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036212

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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