UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056015 |
|---|---|
| Receipt number | R000064015 |
| Scientific Title | Influence of ovarian hormones on inflammatory responses and indirect markers of muscle injury following exercise-induced muscle damage |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2024/11/06 12:08:01 |
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Basic information
Public title
Influence of ovarian hormones on inflammatory responses and indirect markers of muscle injury following exercise-induced muscle damage
Acronym
Influence of ovarian hormones on inflammatory responses and indirect markers of muscle injury following exercise-induced muscle damage
Scientific Title
Influence of ovarian hormones on inflammatory responses and indirect markers of muscle injury following exercise-induced muscle damage
Scientific Title:Acronym
Influence of ovarian hormones on inflammatory responses and indirect markers of muscle injury following exercise-induced muscle damage
Region
| Japan |
Condition
Condition
Exercise-induced muscle damage
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aimed to determine the effect of sex differences and ovarian hormone concentrations in inflammatory response and muscle damage following eccentric exercise
Basic objectives2
Others
Basic objectives -Others
The present study aimed to determine the effect of sex differences and ovarian hormone concentrations in inflammatory response and muscle damage following eccentric exercise
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood samples are collected at pre- and 4,48 and 96 h postexercise to analyze estradiol and progesterone concentrations, leukocyte count and fractionation, interleukin-6, and creatine kinase activity. Also assess the maximal voluntary isometric contraction torque of elbow flexion, range of motion in elbow joint, upper-arm circumference, and muscle soreness as indirect muscle damage markers at pre-; immediately post; and 4,48,96 h postexercise.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Eccentric exercise using non-dominant arms
10 sets of maximal voluntary isokinetic eccentric exercises elbow flexors at a velocity of 90 degree/s for ROM from 90 degree-0 degree flexion, indicating a full extension
(rest for 2 min between sets)
Interventions/Control_2
Eccentric exercise using non-dominant arms
10 sets of maximal voluntary isokinetic eccentric exercises elbow flexors at a velocity of 90 degree/s for ROM from 90 degree-0 degree flexion, indicating a full extension
(rest for 2 min between sets)
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All participant
1) no resistance training or vigorous exercises for at least 6 months before the study
2) no musculoskeletal injury reported in the last 6 months
3) no existing disease and metabolic or hormonal disorder
4) no regular use of medication or dietary supplements that could affect the results
5) no smoking
Female participant
1) regular menstrual cycle length (25-38 days)
2) no oral contraceptives administered exercises for at least 6 months
3) no pregnancies in the previous year, no period of lactation
Key exclusion criteria
who do not comply with the inclusion criteria
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Funaki |
Organization
Teikyo University of Science
Division name
Faculty of Medical Sciences
Zip code
409-0193
Address
2525 Yatsusawa, Uenohara, Yamanashi, Japan
TEL
0554-63-4411
a-funaki@ntu.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Funaki |
Organization
Teikyo University of Science
Division name
Faculty of Medical Sciences
Zip code
409-0193
Address
2525 Yatsusawa, Uenohara, Yamanashi, Japan
TEL
0554-63-4411
Homepage URL
a-funaki@ntu.ac.jp
Sponsor or person
Institute
Teikyo University of Science
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Grant-in-Aid for Scientific Research(C)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University of Science
Address
2525 Yatsusawa, Uenohara, Yamanashi, Japan
Tel
0554-63-4411
a-funaki@ntu.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
日本体育大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | 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
36
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
| 2022 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 07 | 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
| 2024 | Year | 11 | Month | 01 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064015
