UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054572 |
|---|---|
| Receipt number | R000062177 |
| Scientific Title | An exploratory study to examine the effects of verbal encouragement on exercise performance in healthy adult males |
| Date of disclosure of the study information | 2024/06/06 |
| Last modified on | 2024/10/28 16:01:11 |
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Basic information
Public title
An exploratory study to examine the effects of verbal encouragement on exercise performance in healthy adult males
Acronym
An exploratory study to examine the effects of verbal encouragement on exercise performance in healthy adult males
Scientific Title
An exploratory study to examine the effects of verbal encouragement on exercise performance in healthy adult males
Scientific Title:Acronym
An exploratory study to examine the effects of verbal encouragement on exercise performance in healthy adult males
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effects of verbal encouragement on exercise performance in healthy adult males.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total power in 40 seconds of full power pedaling
Key secondary outcomes
VO2, VE, VCO2, RER, RR, Maximum power, Minimum power, Power exerted at each time, Fatigue index, Heart rate, RPE, Post-exercise questionnaire
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Without verbal encouragement -> With verbal encouragement -> Verbal encouragement by mask wearers -> Without verbal encouragement in the laboratory after verbal encouragement
Interventions/Control_2
With verbal encouragement -> Verbal encouragement by mask wearers -> Without verbal encouragement in the laboratory after verbal encouragement -> Without verbal encouragement
Interventions/Control_3
Verbal encouragement by mask wearers -> Without verbal encouragement in the laboratory after verbal encouragement -> Without verbal encouragement -> With verbal encouragement
Interventions/Control_4
Without verbal encouragement in the laboratory after verbal encouragement -> Without verbal encouragement -> With verbal encouragement -> Verbal encouragement by mask wearers
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
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
1)Those who have given written consent to participate in this study.
2)Healthy adult male over 20 years old.
3)Those who have an exercise habit (jogging, treadmill running, bicycling, etc. at least twice a week for at least 30 minutes each time).
4)Those who are able to eat, maintain rest, and exercise load on a schedule dictated by the researcher.
Key exclusion criteria
1)Persons with a history of or with disorders of the digestive, circulatory, respiratory, or endocrine systems, etc., who are judged by the principal investigator to be ineligible for the study.
2)Persons who are regularly using drugs for the treatment of a disease and who are deemed by the principal investigator to be ineligible for the study.
3)Persons taking health foods or supplements that may affect the study.
4)Others (e.g., electrocardiogram abnormalities, clinical laboratory values, etc.) for whom the principal investigator and principal investigator determine that they are inappropriate as subjects.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Minoru |
| Middle name | |
| Last name | Akiyama |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Saga Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5 Yoshinogari-cho Kanzaki-gun, Saga
TEL
0952-52-1522
Akiyama.Minoru@otsuka.jp
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Akiyama |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Saga Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5 Yoshinogari-cho Kanzaki-gun, Saga
TEL
0952-52-1522
Homepage URL
Akiyama.Minoru@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Otsuka Pharmaceutical Co., Ltd.
Address
Shinagawa Grand Central Tower, 2-16-4, Konan, Minato-ku, Tokyo
Tel
03-6717-1499
shimizu_se@otsuka.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
| 2024 | Year | 06 | Month | 06 | 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
16
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
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 05 | Day |
Last modified on
| 2024 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062177
