UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018956 |
|---|---|
| Receipt number | R000021934 |
| Scientific Title | The effects of lower limb compression stocking on perceived fatigue and lower limb blood flow after prolonged walking among Japanese adults |
| Date of disclosure of the study information | 2015/09/11 |
| Last modified on | 2015/09/10 13:48:01 |
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Basic information
Public title
The effects of lower limb compression stocking on perceived fatigue and lower limb blood flow after prolonged walking among Japanese adults
Acronym
he effects of lower limb compression stocking on perceived fatigue and lower limb blood flow
Scientific Title
The effects of lower limb compression stocking on perceived fatigue and lower limb blood flow after prolonged walking among Japanese adults
Scientific Title:Acronym
he effects of lower limb compression stocking on perceived fatigue and lower limb blood flow
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investing the effects of lower limb compression stocking on perceived fatigue and lower limb blood flow after prolonged walking among Japanese adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Edema distribution of lower-limb muscle measured by MRI (before and after walking exercise)
2.Perceived lower-limb muscle fatigue measured by VAS (before and after walking exercise)
Key secondary outcomes
1.Arterial and venous blood flow measured by Doppler ultrasonography (before and after walking exercise)
2.Blood pressure (before and after walking exercise)
3.Body composition (before and after walking exercise)
4.Hart rate (during walking exercise)
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Walking on the treadmill wearing compression stocking on the lower-limb
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Healthy subjects
2.Over 20 years old men and women
Key exclusion criteria
1.Participants without medical history such as head injury, nervous affection, and psychological disorder
2.Participants who must use of chronic disease medications
3. Participants who cannot walking
4.Participants with claustrophobia 5.Participants with a permanent pacemaker and other implanted
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoichi Nagatomi |
Organization
Tohoku University Graduate School of Biomedical Engineering
Division name
Division of Biomedical Engineering for Health and Welfare
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-8588
Nagatomi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoichi Nagatomi |
Organization
Tohoku University Graduate School of Biomedical Engineering
Division name
Division of Biomedical Engineering for Health and Welfare
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-8588
Homepage URL
Nagatomi@med.tohoku.ac.jp
Sponsor or person
Institute
Division of Biomedical Engineering for Health and Welfare, Tohoku University Graduate School of Biomedical Engineering
Institute
Department
Personal name
Funding Source
Organization
TORAY OPELONTEX 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
Address
Tel
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
| 2015 | Year | 09 | Month | 11 | 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
| 2015 | Year | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 09 | Day |
Last modified on
| 2015 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021934
