UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056758 |
|---|---|
| Receipt number | R000064869 |
| Scientific Title | Muscle cramp threshold frequency in delayed onset muscle soreness and its sex differences |
| Date of disclosure of the study information | 2025/01/20 |
| Last modified on | 2025/01/20 11:08:46 |
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Basic information
Public title
Lengthening contraction-induced muscle cramp and the sex differences
Acronym
Exercise-induced muscle cramp and the sex differences
Scientific Title
Muscle cramp threshold frequency in delayed onset muscle soreness and its sex differences
Scientific Title:Acronym
Sex differences in the development of muscle cramp after exercise
Region
| Japan |
Condition
Condition
Asymptomatic volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effects of delayed onset muscle soreness on the induction of muscle cramp using muscle cramp threshold frequency evoked by electrical stimulation in participants underwent lengthening contractions.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Electrical muscle cramp threshold frequency (CTF); Perceived pain intensity using visual analogue scale (VAS); pain quality using McGill pain questionaire (MPQ)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Exercise (Lengthening contractions)
Interventions/Control_2
Sex differences
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy University Student
Key exclusion criteria
Taking medication (Painkillers, anti-depressive drugs, etc): Pain patients
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Taguchi |
Organization
Niigata University of Health and Welfare
Division name
Department of Physical Therapy, Faculty of Rehabilitation
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata 950-3198
TEL
0252574767
tagu@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Taguchi |
Organization
Niigata University of Health and Welfare
Division name
Department of Physical Therapy, Faculty of Rehabilitation
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata 950-3198
TEL
0252574767
Homepage URL
tagu@nuhw.ac.jp
Sponsor or person
Institute
Niigata Univeristy of Health and Welfare
Institute
Department
Personal name
Toru Taguchi
Funding Source
Organization
Niigata Univeristy of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata 950-3198
Tel
0252574767
tagu@nuhw.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 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 01 | Month | 20 | Day |
Last modified on
| 2025 | 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=R000064869
