UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000058949
Receipt number R000067414
Scientific Title A Randomised Controlled Trial Investigating Changes in Olfactory Thresholds Before and After Exercise at the Anaerobic Threshold Level During Moderate-Intensity Continuous Exercise and High-Intensity Interval Training
Date of disclosure of the study information 2025/09/01
Last modified on 2025/09/01 10:18:15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Investigation of Changes in Olfactory Thresholds at Different Exercise Intensities

Acronym

Examination of the Effects of Differences in Exercise Intensity on Changes in Olfactory Threshold

Scientific Title

A Randomised Controlled Trial Investigating Changes in Olfactory Thresholds Before and After Exercise at the Anaerobic Threshold Level During Moderate-Intensity Continuous Exercise and High-Intensity Interval Training

Scientific Title:Acronym

Examination of the Effects of Differences in Exercise Intensity on Changes in Olfactory Threshold

Region

Japan


Condition

Condition

none

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine changes in olfactory thresholds before and after two exercises of differing intensity but identical exercise volume

Basic objectives2

Others

Basic objectives -Others

Examination of Changes in Appetite Perception Before and After Exercise

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in olfactory threshold before and after exercise

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

moderate intensity continuous exercise at anaerobic threshold level

Interventions/Control_2

high intensity interval exercise

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

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

All applicants who applied via the poster, excluding those who did not meet the contraindications for cardiopulmonary exercise testing and those without sinusitis.

Key exclusion criteria

Individuals contraindicated for cardiopulmonary exercise testing
Individuals with sinusitis

Target sample size

40


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

rehabilitation medicine

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan.

TEL

0227177353

Email

satoru.ebihara.c4@tohoku.ac.jp


Public contact

Name of contact person

1st name Taiki
Middle name
Last name Katsumata

Organization

tohoku university graduate school of medicine

Division name

rehabilitation medicine

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan.

TEL

09099022778

Homepage URL


Email

katsumata.taiki.q4@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

Government offices of other countries

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, Japan.

Tel

0227284105

Email

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

2025 Year 09 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

Preinitiation

Date of protocol fixation

2025 Year 06 Month 22 Day

Date of IRB


Anticipated trial start date

2025 Year 09 Month 01 Day

Last follow-up date

2028 Year 03 Month 03 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2025 Year 09 Month 01 Day

Last modified on

2025 Year 09 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067414