UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059137 |
|---|---|
| Receipt number | R000067648 |
| Scientific Title | Effects of Active versus Passive Cool-Down on Oxidative Stress Markers (d-ROMs, BAP, OSI) in Healthy Young Men: A Randomized Crossover Trial |
| Date of disclosure of the study information | 2025/09/19 |
| Last modified on | 2025/09/19 17:36:53 |
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Basic information
Public title
Effects of Active vs Passive Cool-Down on Oxidative Stress After Exercise: Randomized Crossover Trial
Acronym
AC-PC Redox Trial
Scientific Title
Effects of Active versus Passive Cool-Down on Oxidative Stress Markers (d-ROMs, BAP, OSI) in Healthy Young Men: A Randomized Crossover Trial
Scientific Title:Acronym
ACPC-REDOX
Region
| Japan |
Condition
Condition
Not applicable (healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether active vs passive cool-down after exercise differentially affects the recovery of oxidative stress markers (d-ROMs, BAP, OSI) in a randomized crossover design.
Basic objectives2
Others
Basic objectives -Others
Mechanistic/physiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
d-ROMs (U.CARR) immediately after the 10-min cool-down (Post-CD) following incremental exercise.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Immediately after the graded exercise test, perform 10 minutes of light-load pedaling (approximately 20 W on a bicycle ergometer, aiming for 60 rpm). Each participant was assigned to one of two periods and two sequences (AB or BA). After a washout period of at least 7 days, the other condition was performed. The test time was standardized within the range of 1:00 PM to 4:00 PM and kept consistent for each individual. Pre-test restrictions were standardized: no exercise for 24 hours, no alcohol for 24 hours, no caffeine for 12 hours, at least 3 hours after eating, and adequate hydration.
Interventions/Control_2
Immediately after incremental exercise, participants underwent 10 min of seated passive rest. All other procedures (sequence, washout, timing window, pre-test restrictions) were identical to AC.
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
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy young men
Able to safely perform the exercise test and cool-down interventions (AC/PC)
Provided written informed consent
Key exclusion criteria
History of cardiovascular, metabolic, or respiratory disease
Acute infection/inflammation or musculoskeletal conditions limiting exercise
Current smokers or regular medication use (including high-dose antioxidant supplements)
Any condition judged by investigators to interfere with participation
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Atsuya |
| Middle name | |
| Last name | Otsuka |
Organization
International University of Health and Welfare, Odawara School of Health and Medical Sciences
Division name
Department of Physical Therapy
Zip code
250-8588
Address
1-2-25 Shiroyama, Odawara-shi, Kanagawa 250-8588, Japan
TEL
0465-21-6724
otsuka-atsuya-ic@ihwg.jp
Public contact
Name of contact person
| 1st name | Atsuya |
| Middle name | |
| Last name | Otsuka |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
250-8588
Address
1-2-25 Shiroyama, Odawara-shi, Kanagawa 250-8588,
TEL
0465-21-6724
Homepage URL
otsuka-atsuya-ic@ihwg.jp
Sponsor or person
Institute
Health Science University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Health Science University
Address
7187 Kodachi, Fujikawaguchiko Town, Minamitsuru District, Yamanashi Prefecture
Tel
0555-83-5200
otsuka-atsuya-ic@ihwg.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
--- Select One ---
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 19 | Day |
Related information
URL releasing protocol
https://1drv.ms/b/c/9f43454bd26e0dcc/EWnVOgXGj6NKs7C6bEwmDE8BMlRJEguswyRvRefdHKqNDA?e=7h5fD7
Publication of results
Unpublished
Result
URL related to results and publications
https://1drv.ms/b/c/9f43454bd26e0dcc/EdxGsjrV7chPtk5j_zEHTnsBkvO4fPOE91w9cH9QaBih6w?e=W26GS2
Number of participants that the trial has enrolled
9
Results
This randomized crossover study in healthy young adults showed that active cool-down (AC) produced a greater reduction in d-ROMs from Post to Post-cool-down than passive cool-down (PC). BAP rose immediately after exercise and partially regressed during recovery. OSI/MR did not change significantly.
Results date posted
| 2025 | Year | 09 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age 22.0 [22.0-22.0] years; height 170.2 [169.7-171.1] cm; weight 66.2 [62.8-72.9] kg; BMI 22.8 [21.7-23.6] kg/m2; healthy volunteers.
Participant flow
Enrolled 9, randomized 9; completed both AC and PC conditions 9; analyzed 9; no dropouts.
Adverse events
No adverse events were observed.
Outcome measures
Primary outcome: d-ROMs immediately after the 10-min cool-down (Post-CD).
Secondary outcomes: BAP; *OSI = (d-ROMs/BAP)100; MR = (BAP/d-ROMs)/7.51.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 24 | 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 | 09 | Month | 19 | Day |
Last modified on
| 2025 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067648
