UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063551 |
|---|---|
| Receipt number | R000072725 |
| Scientific Title | Comparison of Exercise-Induced Hypoalgesia and Its Time Course Following Low- and High-Intensity Cycle Ergometer Exercise and Lumbar Extension Exercise in Healthy Adults |
| Date of disclosure of the study information | 2026/11/06 |
| Last modified on | 2026/11/06 19:26:18 |
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Basic information
Public title
Comparison of Exercise-Induced Hypoalgesia and Its Time Course Following Low- and High-Intensity Cycling and Repeated Lumbar Extension Exercise in Healthy Adults
Acronym
Exercise-Induced Hypoalgesia Following Cycling and Repeated Lumbar Extension Exercise
Scientific Title
Comparison of Exercise-Induced Hypoalgesia and Its Time Course Following Low- and High-Intensity Cycle Ergometer Exercise and Lumbar Extension Exercise in Healthy Adults
Scientific Title:Acronym
Exercise-Induced Hypoalgesia Following Cycling and Repeated Lumbar Extension Exercise
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exercise-induced hypoalgesia (EIH) refers to a temporary reduction in pain sensitivity associated with physical exercise. This study aims to compare the magnitude and time course of EIH over 60 minutes following low- and high-intensity cycle ergometer exercise and repeated lumbar extension in lying (EIL) in healthy adults.
Basic objectives2
Others
Basic objectives -Others
Comparison of the magnitude and time course of exercise-induced hypoalgesia across different exercise modalities and intensities
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in pressure pain threshold (PPT) at the nail bed from the pre-exercise baseline. PPT will be measured at five time points: immediately before exercise, immediately after exercise, and 20, 40, and 60 minutes after exercise. The magnitude and time course of exercise-induced hypoalgesia (EIH) will be evaluated based on changes in PPT from baseline.
Key secondary outcomes
1. Changes in pressure pain threshold (PPT) at the tibialis anterior muscle from the pre-exercise baseline. PPT will be measured immediately before exercise, immediately after exercise, and 20, 40, and 60 minutes after exercise.
2. Heart rate: Measured immediately before exercise, during exercise, immediately after exercise, and 20, 40, and 60 minutes after exercise.
3. Rating of perceived exertion (RPE): Assessed during exercise using the Borg scale.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants will perform approximately 20 minutes of low-intensity cycle ergometer exercise at 40-60% of heart rate reserve (HRR), determined using the Karvonen method. Each participant will complete this condition once, along with the other two exercise conditions, in a randomized order. Sessions will be conducted on separate days, with an interval of at least 2-3 days between sessions.
Interventions/Control_2
Participants will perform approximately 20 minutes of high-intensity cycle ergometer exercise at 50-80% of heart rate reserve (HRR), determined using the Karvonen method. Each participant will complete this condition once, along with the other two exercise conditions, in a randomized order. Sessions will be conducted on separate days, with an interval of at least 2-3 days between sessions.
Interventions/Control_3
Participants will perform repeated lumbar extension in lying (EIL). From a prone position, participants will lift their upper body by extending their elbows to achieve maximum lumbar extension. At the end range, participants will apply additional force in the direction of extension using their own muscular effort. The exercise will consist of six sets of five repetitions (30 repetitions in total), with a 15-second rest interval between sets. Each participant will complete this condition once, along with the other two exercise conditions, in a randomized order. Sessions will be conducted on separate days, with an interval of at least 2-3 days between sessions.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Undergraduate or graduate students enrolled at Saitama Prefectural University who are healthy, defined as having been free from symptoms for at least one month, except for menstrual pain.
2. Individuals aged 18 years or older.
3. Individuals whose first language is Japanese.
Key exclusion criteria
1. Individuals who are pregnant or may be pregnant.
2. Individuals with current pain, including low back pain or neck pain.
3. Individuals with a history of respiratory disease.
4. Individuals with a history of neurological disease.
5. Individuals with a history of psychiatric disorders.
6. Individuals who have been advised by a physician to avoid exercise.
7. Individuals with a history of conditions that may cause low back pain, such as lumbar spondylolisthesis or lumbar disc herniation.
8. Individuals with a history of conditions or injuries that prevent trunk push-up movements, such as wrist or forearm fractures.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Takasaki |
Organization
Saitama Prefectural University
Division name
Department of Physical Therapy
Zip code
3438540
Address
820 Sannomiya, Koshigaya, Saitama, Japan
TEL
0489734706
takasaki-hiroshi@spu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Takasaki |
Organization
Saitama Prefectural University
Division name
Department of Physical Therapy
Zip code
3438540
Address
820 Sannomiya, Koshigaya, Saitama, Japan
TEL
0489734706
Homepage URL
takasaki-hiroshi@spu.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Hiroshi Takasaki
Funding Source
Organization
Japan Society for the Promotion of Science
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
Saitama Prefectural University
Address
820 Sannomiya, Koshigaya, Saitama, Japan
Tel
0489734706
rinri@spu.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
| 2026 | Year | 11 | Month | 06 | 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
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 11 | Month | 06 | Day |
Last modified on
| 2026 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072725
