UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053375 |
|---|---|
| Receipt number | R000060918 |
| Scientific Title | Effects of increased physical activity on sleep status in ICU admitted patients: a prospective cohort study |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2026/04/09 22:15:40 |
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Basic information
Public title
Effects of increased physical activity on sleep status in ICU admitted patients: a prospective cohort study
Acronym
Effects of increased physical activity on sleep status in ICU admitted patients: a prospective cohort study
Scientific Title
Effects of increased physical activity on sleep status in ICU admitted patients: a prospective cohort study
Scientific Title:Acronym
Effects of increased physical activity on sleep status in ICU admitted patients: a prospective cohort study
Region
| Japan |
Condition
Condition
ICU admitted patients who are able to communicate
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main clinical hypothesis is that increased physical activity and exercise in patients admitted to the ICU will improve sleep quality.
Sleep status will be compared between patients in bed rest and those who have reached an exercise intensity of at least end-sitting, and if the percentage of deep sleep (N2+N3) increases with increased physical activity and exercise, and is significantly higher than in bed rest, then it will be considered valid.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
It shall be the total time of N2+N3 obtained from PSG.
Sleep status will be evaluated twice, once when the patient is in a resting supine position and once after reaching an exercise intensity of at least end-sitting position.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Sleep status will be evaluated twice, once when the patient is in a resting supine position and once after reaching an exercise intensity of at least end-sitting position.
The evaluation method involves wearing a PSG from 9:00 p.m. to 6:00 a.m. the next morning to observe sleep stages and to assess subjective sleep quality using the Richards-Campbell Sleep Questionnaire.
Interventions/Control_2
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
| 18 | years-old | < |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients over 18 years of age who are able to communicate and admitted to the ICU
Key exclusion criteria
Patients unable to communicate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Doi |
Organization
Tokushima University Hospital
Division name
Multidisciplinary Care Unit ICU
Zip code
770-0042
Address
2-50-1 Kuramoto-cho, Tokushima City, Tokushima Prefecture
TEL
088-633-9342
s.doi@kangotoku.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Doi |
Organization
Tokushima University Hospital
Division name
Multidisciplinary Care Unit ICU
Zip code
770-0042
Address
2-50-1 Kuramoto-cho, Tokushima City, Tokushima Prefecture
TEL
088-633-9342
Homepage URL
s.doi@kangotoku.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
No research expenses
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
Tokushima Univer City
Address
2-50-1 Kuramoto-cho, Tokushima City, Tokushima Prefecture
Tel
088-633-9294
first-ec@tokushima-u.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 01 | 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
100
Results
Sixty-two of 100 patients were analyzed. The unadjusted mean N2+N3 sleep duration was 296.8 minutes before mobilization and 284.0 minutes on the mobilization night (p = 0.644). After adjustment using a linear mixed-effects model, mobilization had no significant independent effect (+0.4 minutes, 95% CI: -34.2 to 35.0; p = 0.982). The interaction with ICU timing was not significant (p = 0.168), although exploratory analysis suggested decreased N2+N3 sleep early and improvement later during ICU stay.
Results date posted
| 2026 | Year | 04 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Characteristic Value
Participants, n 62
Values are median (IQR) or n (%). Primary diagnosis is shown for the top categories.
Age, years 74.0 (69.2-76.8)
Male sex 45 (72.6%)
BMI, kg/m2 22.9 (21.0-26.1)
APACHE score 23.0 (18.2-31.5)
SOFA score 9.0 (7.0-13.0)
ICU length of stay, days 5.0 (4.0-9.0)
Mechanical ventilation 55 (88.7%)
Sedation category
None 36 (58.1%)
Dexmedetomidine 25 (40.3%)
Midazolam 1 (1.6%)
Hypnotic use 13 (21.0%)
Primary diagnosis (top categories)
Respiratory failure 24 (38.7%)
Cardiac surgery (valvular disease) 7 (11.3%)
Sepsis 7 (11.3%)
Others 4(6.5%)
Cardiac surgery (aortic dissection) 4 (6.5%)
Cardiac surgery (other) 4 (6.5%)
Other diagnoses 12 (19.4%)
Participant flow
Patients admitted to the ICU between June 2024 and February 2026 were consecutively enrolled.
Adverse events
None
Outcome measures
The unadjusted mean N2+N3 sleep duration was 296.8 minutes on the night before mobilization and 284.0 minutes on the night of mobilization (p = 0.644). After adjustment using a linear mixed-effects model (adjusted for sedatives, mechanical ventilation, hypnotics, suctioning, and number of position changes), the independent effect of mobilization was +0.4 minutes (95% CI: -34.2 to 35.0; p = 0.982), indicating no significant improvement.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 09 | Day |
Date of closure to data entry
| 2026 | Year | 04 | Month | 09 | Day |
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 04 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 17 | Day |
Last modified on
| 2026 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060918
