UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000060416
Receipt number R000063909
Scientific Title Effects of different exercise mode on cardiovascular disease risks and examamination of underlying mechanism of exercise effects
Date of disclosure of the study information 2026/01/20
Last modified on 2026/01/20 21:03:00

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Basic information

Public title

Effects of different exercise mode on cardiovascular disease risks and examamination of underlying mechanism of exercise effects

Acronym

Effects of different exercise mode on cardiovascular disease risks and examamination of underlying mechanism of exercise effects

Scientific Title

Effects of different exercise mode on cardiovascular disease risks and examamination of underlying mechanism of exercise effects

Scientific Title:Acronym

Effects of different exercise mode on cardiovascular disease risks and examamination of underlying mechanism of exercise effects

Region

Japan


Condition

Condition

Adult women and men from ages 20 to 60

Classification by specialty

Medicine in general Cardiology Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate the effects and mechanisms of habitual aerobic exercise, interval exercise, resistance exercise, and short-term high-intensity interval exercise on the risk of cardiovascular disease.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Effects of 8 weeks of aerobic exercise, interval exercise, resistance exercise, and short-term high-intensity interval exercise on cardiovascular disease risk

Key secondary outcomes

Effects of 8 weeks of aerobic exercise, interval exercise, resistance exercise, and short-term high-intensity interval exercise on physical and mental health


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

5

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Sedentary control group

Interventions/Control_2

Aerobic exercise training group

Interventions/Control_3

Interval exercise training group

Interventions/Control_4

High-intensity intermittent training group

Interventions/Control_5

Resistance traininig group

Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

60 years-old >=

Gender

Male and Female

Key inclusion criteria

Adult men and women aged 20 to 60 years who do not meet the exclusion criteria will be selected.

Key exclusion criteria

1) Subjects with serious illnesses that contraindicate exercise (cardiovascular disease, renal failure, severe obesity, orthopedic disorders, etc.)
2) Subjects who are visiting a hospital or taking medication for arrhythmia
3) Subjects who are visiting a hospital or taking medication for depression or other mental disorders

Target sample size

90


Research contact person

Name of lead principal investigator

1st name Motoyuki
Middle name
Last name Iemitsu

Organization

Ritsumeikan University

Division name

Faculty of Sport and Health Science

Zip code

525-8577

Address

1-1-1 Noji-Higashi, Kusatsu, Shiga

TEL

0775994131

Email

iemitsu@fc.ritsumei.ac.jp


Public contact

Name of contact person

1st name Motoyuki
Middle name
Last name Iemitsu

Organization

Ritsumeikan University

Division name

Faculty of Sport and Health Science

Zip code

525-8577

Address

1-1-1 Noji-Higashi, Kusatsu, Shiga

TEL

0775994131

Homepage URL


Email

iemitsu@fc.ritsumei.ac.jp


Sponsor or person

Institute

Ritsumeikan University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)

Grant from Kusatsu City


IRB Contact (For public release)

Organization

Ethics committee of Ritsumeikan University

Address

1-1-1 Nojihigashi, Kusatsu, Shiga

Tel

077-561-3412

Email

b-rinri@st.ritsumei.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 01 Month 20 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

Open public recruiting

Date of protocol fixation

2023 Year 12 Month 01 Day

Date of IRB

2024 Year 06 Month 17 Day

Anticipated trial start date

2024 Year 11 Month 05 Day

Last follow-up date

2025 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 01 Month 20 Day

Last modified on

2026 Year 01 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063909