UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059292 |
|---|---|
| Receipt number | R000067819 |
| Scientific Title | The effects of low-intensity stretching on sleep quality and subjective psychological stress |
| Date of disclosure of the study information | 2025/10/10 |
| Last modified on | 2025/10/05 10:29:08 |
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Basic information
Public title
The effects of stretching on sleep and psychological stress
Acronym
Stretching and sleep/stress
Scientific Title
The effects of low-intensity stretching on sleep quality and subjective psychological stress
Scientific Title:Acronym
Effects of stretching on sleep and stress
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the effects of performing stretching exercises before bedtime on stress levels, sleep state, sleep structure, and core body temperature changes in young adults reporting low subjective sleep quality, comparing these outcomes to a condition where no stretching is performed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep architecture
The Depression Anxiety Stress Scales
3-Dimensional sleep scale
Key secondary outcomes
Core Body Temperature
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Full-body stretch (10 minutes)
Interventions/Control_2
normal lifestyle
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults (both men and women) with low subjective sleep quality (Pittsburgh Sleep Quality Index score of 6 to 10). For women, a shortened version of the DRSP with a score of 12 or lower.
Key exclusion criteria
1.Individuals who currently engage in regular exercise at least three days per week 1. Individuals who exercise regularly at least three days a week.
2.Individuals undergoing regular medical visits and medication for mental disorders or sleep disorders.
3.Individuals receiving treatment for physical illnesses or injuries.
4.Individuals planning long-term trips or travel across time zones during the intervention period.
5.Individuals with amenorrhea or significantly irregular menstrual cycles.
6.Individuals deemed by the principal investigator to be at risk of health deterioration due to participation in the experiment.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | MASAKI |
| Middle name | |
| Last name | NISHIDA |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192 JAPAN
TEL
0429476771
nishida@waseda.jp
Public contact
Name of contact person
| 1st name | MASAKI |
| Middle name | |
| Last name | NISHIDA |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192 JAPAN
TEL
0429476771
Homepage URL
nishida@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Masaki Nishida
Funding Source
Organization
Waseda University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University Ethics Review Committee for Research Involving Human Subjects
Address
513 Waseda-Tsurumakicho, Shinjuku, Tokyo 162-0041 JAPAN
Tel
03-5272-1639
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
| 2025 | Year | 10 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 05 | Day |
Last modified on
| 2025 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067819
