UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061191 |
|---|---|
| Receipt number | R000070023 |
| Scientific Title | Effects of different resistance training modalities on muscle strength gains and urinary titin concentration dynamics |
| Date of disclosure of the study information | 2026/04/07 |
| Last modified on | 2026/04/07 21:41:33 |
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Basic information
Public title
Effects of different resistance training modalities on muscle strength gains and urinary titin concentration dynamics
Acronym
Resistance training and urinary titin concentration
Scientific Title
Effects of different resistance training modalities on muscle strength gains and urinary titin concentration dynamics
Scientific Title:Acronym
Resistance training and urinary titin concentration
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the effects of different combinations of training intensity and frequency on quadriceps muscle strength, muscle thickness, skeletal muscle mass, and urinary titin concentration following an 8-week resistance training (RT) program, aiming to determine the optimal exercise dose for effective muscle strengthening.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Isokinetic maximum voluntary contraction of the quadriceps
2) Quadriceps muscle thickness measured by ultrasound
3) Body composition analysis
4) Urinary N-terminal titin fragment concentration (Urine samples collected before the start of RT, at rest at the final RT session, 8 hours post-RT, 96 hours post-RT, and 1 week post-RT)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
High-intensity, high-frequency group(Resistance training at 80% of 1RM, 3 times per week)
Interventions/Control_2
High-intensity, low-frequency group(Resistance training at 80% of 1RM, 1 time per week)
Interventions/Control_3
Low-intensity, high-frequency group(Resistance training at 30% of 1RM, 3 times per week)
Interventions/Control_4
Low-intensity, low-frequency group(Resistance training at 30% of 1RM, 1 time per week)
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
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Healthy male adults aged 20 to 39 years
2) Individuals without a regular exercise habit
Key exclusion criteria
1) Individuals with symptoms such as pain or numbness in the lower extremities
2) Individuals with a history of musculoskeletal disorders in the lower extremities within the past 6 months
3) Individuals judged to have difficulty continuing the exercise program in this study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yukihide |
| Middle name | |
| Last name | Nishimura |
Organization
Iwate Medical University
Division name
Department of Rehabilitation Medicine
Zip code
0283694
Address
1-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate
TEL
019-651-5111
ynishi@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Tsuboi |
Organization
Iwate Medical University Hospital
Division name
Rehabilitation Division
Zip code
0283695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate
TEL
019-613-7111
Homepage URL
tsuppon0417@gmail.com
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Iwate Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Secretariat of the Institutional Review Board, Iwate Medical University Hospital
Address
1-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate
Tel
019-651-5111
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
| 2026 | Year | 04 | Month | 07 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
72
Results
Data collection is complete. Currently under statistical analysis. Will be updated upon completion.
Results date posted
| 2026 | Year | 04 | Month | 07 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Data collection has been completed, and statistical analysis is scheduled to be conducted. To avoid any conflicts with the embargo policies of the target journal regarding the prior disclosure of unpublished data, the results will be registered promptly after the manuscript has been accepted and published.
Date of the first journal publication of results
Baseline Characteristics
Healthy adult males in their 20s and 30s without a regular exercise habit.
Currently under analysis.
Participant flow
Currently under analysis.
Adverse events
Currently under analysis.
Outcome measures
Data collection has been completed, and statistical analysis is scheduled to be conducted.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The protocol of this study (including eligibility criteria, intervention methods, primary outcomes, and pre-determined target sample size) was reviewed and approved by the institutional ethics committee (Approval Number: MH2023-007) on September 1, 2023, prior to the commencement of the study. There have been no deviations from the pre-approved research protocol, nor any retrospective changes to the outcome measures. Note: Although this trial was retrospectively registered after the completion of data collection, the registration was performed strictly after dataset lock and prior to conducting any statistical analysis.
Management information
Registered date
| 2026 | Year | 04 | Month | 07 | Day |
Last modified on
| 2026 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070023
