UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055972 |
|---|---|
| Receipt number | R000063970 |
| Scientific Title | Effects of Single-session Transient Ischemic Loading Using Pneumatic Cuff on Quadriceps Muscle Strength in Healthy Adult Males: A Single-arm Pre-post Intervention Study |
| Date of disclosure of the study information | 2024/10/31 |
| Last modified on | 2024/10/29 05:30:56 |
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Basic information
Public title
Immediate Effect of Ischemic Loading on Quadriceps Muscle Output by Using a Pneumatic Cuff
Acronym
IELQMO (Immediate Effect of Ischemic Loading on Quadriceps Muscle Output)
Scientific Title
Effects of Single-session Transient Ischemic Loading Using Pneumatic Cuff on Quadriceps Muscle Strength in Healthy Adult Males: A Single-arm Pre-post Intervention Study
Scientific Title:Acronym
TIQMS (Transient Ischemic loading on Quadriceps Muscle Strength)
Region
| Japan |
Condition
Condition
This study targets healthy adult males and does not focus on any specific disease (no applicable ICD code).
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effect of transient ischemic conditioning (TIC) on quadriceps muscle strength and to evaluate its potential application as a warm-up exercise in rehabilitation settings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Right Knee Extensor Muscle Strength:
Measurement Timing: Measurements were taken at three time points: immediately before the intervention, 10 minutes after the intervention, and 20 minutes after the intervention.
Measurement Method: Measured in Newton-meters (Nm) using a handheld dynamometer (Micro Total Analysis System; Anima Corporation). Each measurement was conducted twice, with the higher value used for analysis, following the protocol by Katoh et al. (2019). The test-retest reliability of this method was reported by Hirano et al. (2020) with an intra-rater correlation coefficient (ICC) of 0.94.
Key secondary outcomes
None
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention task consisted of transient ischemic conditioning (TIC) applied to the quadriceps muscle. Participants were positioned in a prone (face-down) position on a bed, with pressure applied to the right thigh using a pneumatic cuff (Sankei, 19.5 cm wide) to induce ischemia in the quadriceps muscle. The cuff pressure was set at 200 mmHg, and the ischemic intervention was maintained for 5 minutes. The parameters for cuff pressure and duration were based on findings from Nakajima et al. (2022).
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
Age: 20-39 years
Gender: Male
Health Status: No known medical conditions (healthy adults)
Key exclusion criteria
Systolic blood pressure of 140 mmHg or higher
History of deep vein thrombosis or pulmonary embolism
History of hemorrhagic or embolic cerebrovascular disease
Personal or family history of blood coagulation disorders (e.g., hemophilia) or thrombocytosis (high platelet count)
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tomoki |
| Middle name | none |
| Last name | Kakehashi |
Organization
Nandan Senyo-kai Minamiawaji Hospital
Division name
Rehabilitation Department
Zip code
656-0516
Address
560 Kashu Fukui, Minamiawaji City, Hyogo, Japan.
TEL
0799-53-1553
kakehashi.tomoki@hmw.gr.jp
Public contact
Name of contact person
| 1st name | Tomoki |
| Middle name | none |
| Last name | Kakehashi |
Organization
Nandan Senyo-kai Minamiawaji Hospital
Division name
Rehabilitation Department
Zip code
656-0516
Address
560 Kashu Fukui, Minamiawaji City, Hyogo, Japan
TEL
0799-53-1553
Homepage URL
kakehashi.tomoki@hmw.gr.jp
Sponsor or person
Institute
Nandan Senyo-kai Minamiawaji Hospital Rehabilitation Department Tomoki Kakehashi
Institute
Department
Personal name
Funding Source
Organization
none
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
Kibi International University Ethics Review Committee
Address
Kibi International University, 8 Iga-cho, Takahashi City, Okayama, Japan.
Tel
086-622-3709
apollo@kiui.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
| 2024 | Year | 10 | Month | 31 | 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
15
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
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 10 | 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 | 10 | Month | 29 | Day |
Last modified on
| 2024 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063970
