UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061709 |
|---|---|
| Receipt number | R000070577 |
| Scientific Title | Effects of an 8-Week Walking Habit on Physiological Changes in Healthy Men |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/06/01 13:53:01 |
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Basic information
Public title
Effects of an 8-Week Walking Habit on Physiological Changes in Healthy Men
Acronym
ACTIVE Walk Study
Scientific Title
Effects of an 8-Week Walking Habit on Physiological Changes in Healthy Men
Scientific Title:Acronym
ACTIVE Walk Study
Region
| Japan |
Condition
Condition
Healty male adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the effects of increasing daily physical activity specifically adding 3000 steps per day on physiological and molecular changes in healthy men.
Basic objectives2
Others
Basic objectives -Others
Biomarker exploration
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in circulating microRNA expression levels from baseline to the end of the 8-week walking intervention.
Key secondary outcomes
Changes in body weight, BMI, blood biochemical parameters, physical activity levels, and daily step counts from baseline to the end of the 8-week walking intervention.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants will be instructed to increase their daily physical activity by walking at least 3,000 additional steps per day compared with their baseline level for 8 weeks. Daily step counts and physical activity levels will be measured using a Lifecoder EX accelerometer (Suzuken Co., Ltd., Japan). Participants will maintain their usual lifestyle while increasing physical activity during the intervention period.
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
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
Male participants with no diagnosed medical conditions and no history of regular exercise training during the previous six months were eligible for inclusion.
Key exclusion criteria
Participants with diagnosed cardiovascular, metabolic, respiratory, musculoskeletal, or other medical conditions that could affect participation in the study, or those unable to complete the intervention protocol, were excluded.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Fuku |
Organization
Juntendo University
Division name
Faculty of Health and Sports Science
Zip code
270-1695
Address
Hiraga-gakuendai 1-1, Inzai, Chiba
TEL
+81-476-98-1001
zempo.hirofumi@gmail.com
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Zempo |
Organization
Juntendo University
Division name
Faculty of Health and Sports Science
Zip code
Faculty of Health and Sports Science
Address
Hiraga-gakuendai 1-1, Inzai, Chiba
TEL
+81-476-98-1001
Homepage URL
zempo.hirofumi@gmail.com
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
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
Juntendo University
Address
Hiraga-gakuendai 1-1, Inzai, Chiba
Tel
+81-476-98-1001
sc-rinri@juntendo.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
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-22K11864/
Publication of results
Partially published
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-22K11864/
Number of participants that the trial has enrolled
9
Results
An 8-week intervention in healthy adults increased the participant's average daily step count by more than 3,000 steps, exceeding 8,000 steps per day. Exosomal miRNA analysis before and after the intervention revealed significant reductions in hsa-miR-516a-5p and hsa-miR-518b. These miRNAs were associated with poor cancer prognosis in data from The Cancer Genome Atlas (TCGA). Further studies are needed to elucidate the molecular pathways through which these miRNAs influence cancer progression.
Results date posted
| 2026 | Year | 05 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Nine healthy sedentary adult men (age 33.3 years, height 170.7 cm, body weight 65.9 kg).
Participant flow
Nine participants were enrolled and underwent the 8-week step-count intervention. Two participants failed to achieve the predefined target increase of more than 3,000 steps/day and were excluded from the per-protocol analysis. Data from the remaining seven participants were included in the final analysis.
Adverse events
None.
Outcome measures
Primary outcome: Changes in circulating exosome-derived microRNA (miRNA) profiles.
Secondary outcomes: Expression levels of hsa-miR-516a-5p and hsa-miR-518b, Daily step counts, Moderate-to-vigorous physical activity (MVPA), Concentration of exosomal small RNAs in plasma
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 13 | 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 | 27 | Day |
Last modified on
| 2026 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070577
