UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062957 |
|---|---|
| Receipt number | R000072086 |
| Scientific Title | Effects of physical therapies on lower limb recovery following high-load eccentric exercise: A randomized controlled trial |
| Date of disclosure of the study information | 2026/09/24 |
| Last modified on | 2026/09/17 11:24:35 |
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Basic information
Public title
Effects of recovery methods (microcurrent, icing, and heat) on leg muscle fatigue after squat exercise
Acronym
Leg Recovery Trial
Scientific Title
Effects of physical therapies on lower limb recovery following high-load eccentric exercise: A randomized controlled trial
Scientific Title:Acronym
PT-EIMD Trial (Physical Therapy for Exercise-Induced Muscle Damage)
Region
| Japan |
Condition
Condition
Exercise-induced muscle fatigue (Experimental model in healthy young adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate and compare the recovery effects of various physical therapies (microcurrent, icing, and heat) applied immediately after bodyweight eccentric squat exercise on lower limb motor function (muscle strength and jump height) in exercise-induced muscle fatigue and soreness, thereby identifying optimal immediate recovery protocols for sports and rehabilitation settings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum Voluntary Isometric Contraction (MVIC) of knee extension and Countermovement Jump (CMJ) height. The primary endpoint is set at 24 hours post-exercise task. (Time points: Pre-exercise, Immediately post-exercise, Immediately post-intervention, 24 hours post, and 48 hours post).
Key secondary outcomes
1 Passive knee flexion Range of Motion
2 Thigh circumference
3 Subjective muscle soreness Numeric Rating Scale
Time points
Pre-exercise, Immediately post-exercise, Immediately post-intervention, 24 hours post, and 48 hours post.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Microcurrent group: Receiving microcurrent stimulation to the quadriceps for 30 minutes post-exercise.
Interventions/Control_2
Icing group: Receiving local cooling to the quadriceps with ice packs for 20 minutes post-exercise.
Interventions/Control_3
Heat group: Receiving local heating to the quadriceps with hot packs for 20 minutes post-exercise.
Interventions/Control_4
Control group (Sham / Rest): Resting for 20 minutes post-exercise with an unpowered device attached.
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
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Individuals who wish to participate in this study and provide voluntary written informed consent after receiving a thorough explanation and gaining a sufficient understanding of the study.
2. Healthy males and females aged 18 to 29 years, regardless of their participation in sports clubs or athletic teams.
Key exclusion criteria
1. Individuals who have regularly performed high-load resistance exercises targeting the quadriceps (e.g., barbell squats, leg presses) at least once a week within the past 3 months.
2. Individuals with a current medical condition, history of musculoskeletal disease (e.g., muscle strain, ligament injury), or pain in the knee, hip joint, or thigh of the evaluated limb (take-off leg).
3. Individuals with cardiovascular diseases requiring exercise or blood flow restriction (e.g., hypertension), neurological disorders, or progressive skin diseases.
4. Individuals with contraindications for microcurrent devices (e.g., implanted medical devices or metallic implants in the thigh).
5. Women who are pregnant or may be pregnant.
6. Individuals with contraindications or hypersensitivities to physical therapy interventions (e.g., cold urticaria, thermal sensory impairment, or skin diseases such as contact dermatitis).
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | RYOTA |
| Middle name | |
| Last name | MUROI |
Organization
St. Marianna University School of Medicine
Division name
Department of Sports Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
044-977-8111
ryota.muroi@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | RYOTA |
| Middle name | |
| Last name | MUROI |
Organization
St. Marianna University School of Medicine
Division name
Department of Sports Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
044-977-8111
Homepage URL
ryota.muroi@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
RYOTA MUROI
Funding Source
Organization
St. Marianna University School of Medicine
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
Institutional Review Board of St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
Tel
044-977-8111
k-sienbu.mail@marianna-u.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 | 09 | Month | 24 | 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
| 2026 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 09 | Month | 17 | Day |
Last modified on
| 2026 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072086
