UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061692 |
|---|---|
| Receipt number | R000070588 |
| Scientific Title | The Effects of Low-Intensity Aerobic Exercise on Recurrent Headache |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/28 10:27:52 |
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Basic information
Public title
The Effects of Low-Intensity Aerobic Exercise on Recurrent Headache
Acronym
The Effects of Low-Intensity Aerobic Exercise on Recurrent Headache
Scientific Title
The Effects of Low-Intensity Aerobic Exercise on Recurrent Headache
Scientific Title:Acronym
The Effects of Low-Intensity Aerobic Exercise on Recurrent Headache
Region
| Japan |
Condition
Condition
Headache
Classification by specialty
| Medicine in general | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of low-intensity aerobic exercise, primarily consisting of campus walking along safe walking routes, on headache symptoms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean Headache days
Key secondary outcomes
Headache Impact Test (HIT-6)
Migraine Interictal Burden Scale (MIBS-4)
Medication days
Step counts
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants performed campus walking consisting of six laps per session (approximately 400 m per lap) three times per week.
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged 18 years or older and younger than 30 years
2. Experiencing 4 to 14 headache episodes per month
3. Having at least 2 headache-free days (interictal period) per month
4. Having experienced recurrent headaches for at least 1 year
Key exclusion criteria
1. Having exercise restrictions imposed by a physician
2. Experiencing headaches on 15 or more days per month
3. Using analgesics or anti-inflammatory medications (including over-the-counter medications) on 15 or more days per month
4. Having a history of headaches for less than 1 year
5. Currently participating in another clinical trial
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Sumire |
| Middle name | |
| Last name | Ishiyama |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Center for Medical Sciences
Zip code
300-0394
Address
4669-2, Ami, Ibaraki, Japan
TEL
029-888-4000
ishiyamasu@ipu.ac.jp
Public contact
Name of contact person
| 1st name | Sumire |
| Middle name | |
| Last name | Ishiyama |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Center for Medical Sciences
Zip code
300-0394
Address
4669-2, Ami, Ibaraki, Japan
TEL
029-888-4000
Homepage URL
ishiyamasu@ipu.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefectural University of Health Sciences
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Comittee, Ibaraki Prefectural University of Health Sciences
Address
4669-2 Ami, Ami-mach, Inashiki-gun, Ibaraki, Japan
Tel
029-888-4000
kyoumu@ipu.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 | 06 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 10 | 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 | 05 | Month | 26 | Day |
Last modified on
| 2026 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070588
