UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057087 |
|---|---|
| Receipt number | R000065250 |
| Scientific Title | Effects of aerobic exercise timing on blood pressure during sleep in healthy young men |
| Date of disclosure of the study information | 2025/02/19 |
| Last modified on | 2025/08/21 11:56:15 |
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Basic information
Public title
Effects of aerobic exercise timing on blood pressure during sleep in healthy young men
Acronym
Effects of aerobic exercise timing on blood pressure during sleep in healthy young men
Scientific Title
Effects of aerobic exercise timing on blood pressure during sleep in healthy young men
Scientific Title:Acronym
Effects of aerobic exercise timing on blood pressure during sleep in healthy young men
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study were (1) to compare the effects of morning and afternoon acute aerobic exercise on the autonomic nervous system and sleep quality during sleep in healthy young subjects, and (2) to compare the effects of morning and afternoon acute aerobic exercise on BP during sleep. To achieve these two objectives, this study used a small heart rate (HR) sensor, accelerometer, and wrist-type BP during sleep monitor to evaluate medical indices of the autonomic nervous system, sleep quality, and BP during sleep.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Participants came to the laboratory on three separate visits. During the first visit, participants completed a questionnaire and provided informed consent. Age, height, weight, body fat percentage, BMI, BP, and HR were recorded. Exercise intensity was then calculated using the Karvonen method with age and HR. During the first, second, and third visits, participants completed an aerobic exercise protocol from 9:30-10:00 AM (AM trial), an aerobic exercise protocol from 5:30-6:00 PM (PM trial), and no exercise protocol (CON trial) was completed in random order. During each exercise, a HR monitor (Polar Unite, Polar Corporation, Kempele, Finland) was worn on the right wrist to obtain HR and a rating of perceived exertion (RPE) with a questionnaire. The three trials were separated by one week to eliminate the influence of the previous trial and minimize differences in participants' daily activities. Participants were asked to abstain from alcohol, caffeine, and binge drinking for 24 hours before the visit. After each visit, participants remained at home and wore a wrist-type BP during sleep monitor (HEM-9601T, Omron Healthcare Co., Ltd., Kyoto, Japan) on their left wrist, a sleep monitor (Actigraph wGT3X-BT (Ambulatory Monitoring, Inc., San Diego, CA) on their right wrist, and an HR monitor (WHS-1/RRD-1, Union Tool Co., Ltd., Tokyo, Japan) on their chest before going to sleep at night. Physiological parameters (BP, autonomic function, and sleep quality) were obtained before exercise and during nighttime sleep. All parameters were measured in a quiet room with constant room temperature and humidity (50%). Participants were asked to maintain a normal schedule that included the same bedtime and wake-up time after each exercise session to control for total sleep time. The study was conducted using a randomized crossover design.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Aerobic exercise (bicycle pedaling exercise, bicycle ergometer)
Moderate intensity (65% of preliminary heart rate)
30 minutes
Morning (from 9:30 a.m. to 30 minutes)
Interventions/Control_2
Aerobic exercise (bicycle pedaling exercise, bicycle ergometer)
Moderate intensity (65% of preliminary heart rate)
30 minutes
Morning (30 minutes starting at 5:30 p.m.)
Interventions/Control_3
No exercise
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
| 35 | years-old | > |
Gender
Male
Key inclusion criteria
1) Schedule can be adjusted
2) Body mass index (BMI) is less than 18.5 to 25 kg / m2
3) You can follow the precautions when participating in the experiment
4) No smoking habits
5) Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria
1) If you have a chronic disease
2) When the subject has severe physical symptoms and it is difficult to cooperate with the research
3) In addition, if the person in charge of the survey judges it inappropriate to participate
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Kobayashi |
Organization
Teikyo University of Science
Division name
Center for Fundamental Education
Zip code
120-0045
Address
2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo, Japan
TEL
03-6910-1010
rkobayashi@ntu.ac.jp
Public contact
Name of contact person
| 1st name | RYOTA |
| Middle name | |
| Last name | KOBAYASHI |
Organization
Teikyo University of Science
Division name
Center for Fundamental Education
Zip code
120-0045
Address
2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo, Japan
TEL
03-6910-1010
Homepage URL
rkobayashi@ntu.ac.jp
Sponsor or person
Institute
Center for Fundamental Education, Teikyo University of Science
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University of Science
Address
2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo, Japan
Tel
03-6910-1010
kenkyushien@ntu.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
| 2025 | Year | 02 | Month | 19 | 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
15
Results
Systolic blood pressure and LF at bedtime were significantly lower in the morning condition than in the afternoon and control conditions (P<0.05). HF during sleep was significantly higher in the morning condition than in the control (P<0.01), with no difference from the afternoon. LF/HF during sleep was lower in all conditions than immediately before sleep. Sleep efficiency was significantly higher in the morning condition than in both the control and afternoon conditions (P<0.01).
Results date posted
| 2025 | Year | 08 | Month | 21 | Day |
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
| 2025 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 19 | Day |
Last modified on
| 2025 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065250
