UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047299 |
|---|---|
| Receipt number | R000053925 |
| Scientific Title | The effects of Cryobath(R) on recovery in athletes. |
| Date of disclosure of the study information | 2022/03/28 |
| Last modified on | 2022/09/28 13:17:34 |
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Basic information
Public title
The effects of Cryobath(R) on recovery in athletes.
Acronym
The effects of Cryobath(R) on recovery in athletes.
Scientific Title
The effects of Cryobath(R) on recovery in athletes.
Scientific Title:Acronym
The effects of Cryobath(R) on recovery in athletes.
Region
| Japan |
Condition
Condition
Healthy athlete
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effects of Cryobath(R) on the recovery in athletes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CPK
IL-6
Myoglobin
Key secondary outcomes
d-ROMs
Cortisol
Catecholamine
CMJ
VAS for pain
Sit & Reach
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Using cryobath (R)
Interventions/Control_2
Uncontrolled
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
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
29 athletes belong to Iwaki-FC trained on daily basis and participate in the match.
Key exclusion criteria
Those who cannot participate in the practice specified by the team due to injury or other reasons during the test period.
Those who are on medication or under treatment during the study period.
Those with medical electrical equipment such as cardiac pacemakers.
Those who have been diagnosed with cryoglobulinemic vasculitis.
Those who have a disease of myocardial infarction.
Those who have had symptoms of a cold rash in the past.
Those who have a stroke disorder.
Persons with severe anemia.
Current smokers.
In addition, those who are judged to be unsuitable as subjects by a team personnel or research personnel due to false declarations or fraudulent activities.
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Takahashi |
Organization
EUPHORIA Co., Ltd.
Division name
R&D
Zip code
102-0085
Address
Iidabiru2F 5-5 Rokubancho, Chiyoda-ku, Tokyo-to
TEL
03-6388-9260
ryosuke.takahashi@eu-phoria.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Urushizawa |
Organization
EUPHORIA Co., Ltd.
Division name
Corporate Division
Zip code
102-0085
Address
Iidabiru2F 5-5 Rokubancho, Chiyoda-ku, Tokyo-to
TEL
03-6388-9260
Homepage URL
yuki.urushizawa@eu-phoria.jp
Sponsor or person
Institute
EUPHORIA Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ADD Co., Ltd.
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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6205-6222
suda-clinic_irb@imeq.co.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 | 03 | Month | 28 | 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
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 05 | 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
| 2022 | Year | 03 | Month | 28 | Day |
Last modified on
| 2022 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053925
