UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062804 |
|---|---|
| Receipt number | R000071899 |
| Scientific Title | Effects of carbon dioxide hydrate cryotherapy on knee flexor muscle function recovery trajectory after muscle damage: A randomized controlled trial |
| Date of disclosure of the study information | 2026/09/03 |
| Last modified on | 2026/09/03 15:34:33 |
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Basic information
Public title
Effects of carbon dioxide hydrate cryotherapy on knee flexor muscle function recovery trajectory after muscle damage: A randomized controlled trial
Acronym
Effects of carbon dioxide hydrate cryotherapy on knee flexor muscle function recovery trajectory after muscle damage: A randomized controlled trial
Scientific Title
Effects of carbon dioxide hydrate cryotherapy on knee flexor muscle function recovery trajectory after muscle damage: A randomized controlled trial
Scientific Title:Acronym
Effects of carbon dioxide hydrate cryotherapy on knee flexor muscle function recovery trajectory after muscle damage: A randomized controlled trial
Region
| Japan |
Condition
Condition
Healthy participant
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of carbon dioxide hydrate cryotherapy on the recovery trajectory of knee flexor muscle function following exercise-induced muscle damage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
- Maximal voluntary isometric contraction (MVIC) torque of the knee flexor muscles
- Assessment time points: before induction of exercise-induced muscle damage (PRE), immediately after the eccentric exercise protocol (POST), and at 4.5, 24, 48, 72, and 168 h post-exercise
- Change in MVIC torque from PRE at each post-exercise time point
Key secondary outcomes
The following four outcomes will be assessed at PRE and at 4.5, 24, 48, 72, and 168 h post-exercise, and evaluated as changes from PRE:
- Thigh circumference
- Muscle stiffness (biceps femoris long head [BF], semitendinosus [ST], semimembranosus [SM])
- Pressure-induced muscle soreness (BF, ST, SM)
- Hip flexion range of motion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
CDH group
Local cooling of the knee flexor muscles using 200 g of carbon dioxide hydrate (CDH) for 20 min at POST and 4.5, 24, 48, and 72 h after exercise.
Interventions/Control_2
ICE group
Local cooling of the knee flexor muscles using 200 g of conventional ice for 20 min at POST and 4.5, 24, 48, and 72 h after exercise.
Interventions/Control_3
CON group
No cooling intervention. Participants maintained the same prone position as the other groups for 20 min at POST and 4.5, 24, 48, and 72 h after exercise.
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
- No history of cardiac or cardiovascular disease.
- No neuromuscular or orthopedic diseases of the lower body at the time of the experiment; able to walk independently and perform physical exercise measurements.
Key exclusion criteria
- Participants with insufficient sleep on the night before the measurement, who have not eaten on the day of measurement, or who have other conditions that may affect the measurement results.
- Participants with a history of or current knee injury.
- Participants who have engaged in lower-body resistance training within the previous 6 months.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Akagi |
Organization
Shibaura Institute of Technology
Division name
Systems engineering and Science
Zip code
337-8570
Address
307 Fukasaku, Minuma-ku, Saitama-shi, Saitama
TEL
0487206020
rakagi12@sic.shibaura-it.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Akagi |
Organization
Shibaura Institute of Technology
Division name
Systems engineering and Science
Zip code
337-8570
Address
307 Fukasaku, Minuma-ku, Saitama-shi, Saitama
TEL
0487206020
Homepage URL
rakagi12@sic.shibaura-it.ac.jp
Sponsor or person
Institute
Shibaura Institute of Technology
Institute
Department
Personal name
Funding Source
Organization
NIPPON EKITAN Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Shibaura Institute of Technology
Address
3-7-5 Toyosu, Koto-ku, Tokyo
Tel
03-5859-7340
tgakuji@ow.shibaura-it.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 | 03 | 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
24
Results
Under the present experimental conditions, carbon dioxide hydrate cryotherapy and conventional icing did not accelerate the recovery of muscle function following exercise-induced muscle damage.
Results date posted
| 2026 | Year | 09 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twenty-four healthy young men participated and were randomly assigned to the CDH, ICE, or CON groups with 8 participants in each group (CDH: 22 (2) years, ICE: 23 (1) years, CON: 23 (1) years).
Participant flow
Twenty-four participants were enrolled and randomized, with all completing the 168-hour follow-up and interventions without dropout.
Adverse events
No serious adverse events or unexpected side effects related to the interventions were observed.
Outcome measures
The primary outcome was maximal voluntary isometric contraction torque of the knee flexors. Secondary outcomes included thigh circumference, hip joint range of motion, and hamstring muscle stiffness and pressure-induced soreness.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 22 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 15 | Day |
Date trial data considered complete
| 2026 | Year | 08 | Month | 17 | Day |
Date analysis concluded
| 2026 | Year | 08 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 03 | Day |
Last modified on
| 2026 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071899
