UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048668 |
|---|---|
| Receipt number | R000055412 |
| Scientific Title | Evaluation of changes in urinary titin levels before and after resistance training |
| Date of disclosure of the study information | 2022/08/16 |
| Last modified on | 2022/08/16 12:00:13 |
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Basic information
Public title
Evaluation of changes in urinary titin levels before and after resistance training
Acronym
Evaluation of changes in urinary titin levels before and after resistance training
Scientific Title
Evaluation of changes in urinary titin levels before and after resistance training
Scientific Title:Acronym
Evaluation of changes in urinary titin levels before and after resistance training
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the difference in changes in urinary titin N-terminal fragment levels before and after continuous resistance training.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We measure that urinary titin N-terminal fragment at first time on resistance training and after resistance training for 8 weeks.
Key secondary outcomes
Measurements of isometric maximum voluntary contraction of knee extension before and after 8 weeks of training.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Key inclusion criteria
Healthy men without exercise habits
Key exclusion criteria
Persons with exercise habits.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yukihide |
| Middle name | |
| Last name | Nishimura |
Organization
Iwate Medical University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate
TEL
+81-19-613-7111
ynishi@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Minami |
| Middle name | |
| Last name | Suzuki |
Organization
Iwate Medical University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate
TEL
+81-19-613-7111
Homepage URL
minami44444@gmail.com
Sponsor or person
Institute
Department of Rehabilitation Medicine, Iwate Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Rehabilitation Medicine, Iwate Medical University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Iwate Medical University
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate
Tel
+81-19-651-5111
kenkyu-rinri@j.iwate-med.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
| 2022 | Year | 08 | Month | 16 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
7
Results
Urinary titin levels vary in the rate of change with exercise over 8 weeks.
Results date posted
| 2022 | Year | 08 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Seven healthy men without exercise habits participated in this study.
Participant flow
Explanations were given to seven participants recruited at Iwate Medical University between March 2020 and March 2021, and seven took part; eight weeks of resistance training was carried out and urinary titin levels were measured and analysed before and after the training.
Adverse events
NA
Outcome measures
#Urinary Titin N-Terminal Fragment Level
#Measurement of isometric maximum voluntary contraction of knee extension
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Eight weeks of resistance training of the lower limbs were performed on healthy, non-exercising men. Urinary titin concentrations were measured on the start and end dates of exercise. Urine samples were collected at rest before resistance training and 2, 8, 24 and 72 hours after resistance training to assess changes in urinary titin concentrations.
Management information
Registered date
| 2022 | Year | 08 | Month | 15 | Day |
Last modified on
| 2022 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055412
