UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063212 |
|---|---|
| Receipt number | R000072344 |
| Scientific Title | A randomised controlled trial on the effects of high-intensity interval training and aerobic exercise on mitochondrial-related parameters and exercise tolerance |
| Date of disclosure of the study information | 2026/10/07 |
| Last modified on | 2026/10/07 23:23:45 |
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Basic information
Public title
A randomised controlled trial on the effects of high-intensity interval training and aerobic exercise on mitochondrial-related parameters and exercise tolerance
Acronym
A randomised controlled trial on the effects of high-intensity interval training and aerobic exercise on mitochondrial-related parameters and exercise tolerance
Scientific Title
A randomised controlled trial on the effects of high-intensity interval training and aerobic exercise on mitochondrial-related parameters and exercise tolerance
Scientific Title:Acronym
A randomised controlled trial on the effects of high-intensity interval training and aerobic exercise on mitochondrial-related parameters and exercise tolerance
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to compare the effects of high-intensity interval training (HIIT) and moderate-intensity aerobic exercise on mitochondrial-related indicators (mitochondrial DNA copy number) and exercise tolerance indicators (anaerobic threshold, AT) in healthy adults.
Additionally, as a secondary objective, we will examine the relationship between changes in mitochondrial-related indicators and changes in exercise capacity indicators, and explore the potential of mitochondrial-related indicators as new measures for evaluating exercise load.
Furthermore, we will examine the relationship with maximum oxygen uptake and the sweat lactate threshold to evaluate the effectiveness of exercise intervention from the perspective of mitochondrial function.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in AT before and after the intervention
Change in mitochondrial DNA copy number before and after the intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
High-Intensity Interval Training (HIIT) Group
Exercise Equipment: Stationary Bike
Warm-up: Warm-up and cool-down performed before and after exercise
High-Intensity Exercise: High-intensity exercise determined by a preliminary ramp test. Repeated with intervals.
Interventions/Control_2
Control Group
Exercise equipment: Stationary bicycle ergometer
High-Intensity Interval Training (HIIT) Group
Exercise Equipment: Stationary Bike
Warm-up: Warm-up and cool-down performed before and after exercise (to match the conditions of Group 1)
Exercise protocol: moderate-intensity aerobic exercise (constant load)
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Disease Name: Healthy Individuals
(2) Disease Stage: None
(3) Age: 18 years or older, but under 50 years of age (at the time of enrollment)
(4) Gender: Any
(5) Individuals who have provided written informed consent to participate in the study
Key exclusion criteria
1. Individuals who have been diagnosed with or are suspected of having any of the following conditions during the period below:
Heart disease
Respiratory disease
Metabolic disease
Neurological disease
Muscle disease
2. Individuals who meet any of the following conditions:
Individuals with absolute contraindications to exercise stress testing
Individuals with severe skin conditions at the device implantation site
Pregnant women, women who may be pregnant, or women who are breastfeeding
Individuals who refuse to participate in this study
Individuals whom the principal investigator or a co-investigator deems unsuitable for inclusion in the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Ebihara |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7353
satoru.ebihara.c4@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Mizuka |
| Middle name | |
| Last name | Okada |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7353
Homepage URL
okada.mizuka.t5@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-728-4105
ec-med@grp.tohoku.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 | 10 | Month | 07 | 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 | 09 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2030 | 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 | 10 | Month | 07 | Day |
Last modified on
| 2026 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072344
