UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062849 |
|---|---|
| Receipt number | R000070256 |
| Scientific Title | Multilevel Physiological Effects of Aging and Exercise (M-PACE Study) |
| Date of disclosure of the study information | 2026/09/10 |
| Last modified on | 2026/09/08 17:32:11 |
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Basic information
Public title
A Study on the Effects of Aging and Exercise on Cardiovascular, Cognitive, and Motor Functions
Acronym
HAMM
Scientific Title
Multilevel Physiological Effects of Aging and Exercise (M-PACE Study)
Scientific Title:Acronym
MPACE
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to characterize age-related declines in cardiovascular regulatory function and to explore strategies for preventing cardiovascular disease and dementia. In healthy adults, arterial morphology and hemodynamic responses (blood pressure and blood flow) in the heart, brain, and skeletal muscle will be assessed during physiological perturbations to evaluate vascular function. Comparisons across age groups and habitual exercise status will determine whether regular physical activity attenuates these declines. In addition, an interventional study will examine the effects of structured exercise programs (stretching, aerobic, resistance, and combined training) on cardiovascular regulation. Cognitive function, physical performance, and mood will also be assessed to examine their relationships with cardiovascular regulatory function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Cardiovascular regulatory function (indices of blood pressure regulation and blood flow responses)
Key secondary outcomes
Cognitive function, physical performance, mood scores, body composition, ventilatory and metabolic indices, muscle activity, brain activity, and their relationships with cardiovascular regulatory function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
stretching and balance exercise training
Interventions/Control_2
aerobic exercise training
Interventions/Control_3
resistance training
Interventions/Control_4
combined aerobic and resistance training
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals who are able to provide written informed consent voluntarily
Individuals aged 18 to <90 years at the time of consent
Men and women
Individuals who are physically able to exercise or walk continuously for 30 minutes
For participation in the exercise training intervention, individuals aged <75 years at baseline
For MRI assessments, individuals aged <85 years
Key exclusion criteria
History of neurological disease, heart disease, or stroke. Presence of psychiatric disease. Exercise limitation due to disease. Systolic blood pressure higher than 180 mmHg or diastolic blood pressure higher than 110 mmHg. Habitual smoking within the past year. Pregnancy or possible pregnancy, Implanted pacemaker
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Sugawara |
Organization
National Institute of Advanced Industrial Science and Technology
Division name
Integrated Research Center for Self-Care Technology
Zip code
3058566
Address
1-1-1 Higashi, Tsukuba, Ibaraki, Japan
TEL
08022036943
jun.sugawara@aist.go.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Sugawara |
Organization
National Institute of Advanced Industrial Science and Technology
Division name
Integrated Research Center for Self-Care Technology
Zip code
3058566
Address
1-1-1 Higashi, Tsukbua, Ibaraki, Japan
TEL
+10298617138
Homepage URL
jun.sugawara@aist.go.jp
Sponsor or person
Institute
National Institute of Advanced Industrial Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institute of Advanced Industrial Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
National Institute of Advanced Industrial Science and Technology
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Life Science Experiment Management Office, Safety Management Department
Address
1-1-1 Higashi, Tsukuba, Ibaraki, Japan
Tel
029-861-2120
safe-life-ml@aist.go.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 | 09 | Month | 10 | 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 | 06 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | 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 | 09 | Month | 08 | Day |
Last modified on
| 2026 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070256
