UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042208 |
|---|---|
| Receipt number | R000048182 |
| Scientific Title | Effects of regular exercise on skin moisturizing function in adults |
| Date of disclosure of the study information | 2020/10/25 |
| Last modified on | 2023/10/25 13:08:58 |
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Basic information
Public title
Effects of regular exercise on skin moisturizing function in adults
Acronym
Effects of regular exercise on skin moisturizing function
Scientific Title
Effects of regular exercise on skin moisturizing function in adults
Scientific Title:Acronym
Effects of regular exercise on skin moisturizing function
Region
| Japan |
Condition
Condition
dry skin
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of regular exercise on the skin's moisturizing function in adults aged 30-64 years old with no exercise habits.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Corneal water content and trans-epidermal water loss 8 weeks after the start of exercise
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise for at least 30 minutes twice a week.
Interventions/Control_2
No intervention
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
| 30 | years-old | <= |
Age-upper limit
| 64 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults with no exercise habits
Key exclusion criteria
Persons with a history of skin diseases
Pregnant
Within 6 months after giving birth
Anyone who has smoked within the past year
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Oizumi |
Organization
Shijonawate Gakuen University
Division name
Fundamental Nursing
Zip code
5740001
Address
6-45, Gakuen-cyo, Daito-shi
TEL
0728132601
r-oizumi@un.shijonawate-gakuen.ac.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Oizumi |
Organization
Shijonawate Gakuen University
Division name
Fundamental Nursing
Zip code
5740001
Address
6-45, Gakuen-cyo, Daito-shi
TEL
0728132601
Homepage URL
r-oizumi@un.shijonawate-gakuen.ac.jp
Sponsor or person
Institute
Osaka Prefecture University Graduate School
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Research Ethics Committee, Graduate School of Nursing, Osaka Prefecture University
Address
3-7-30 Habikino, Habikino-shi, Osaka
Tel
072-950-2111
kangorinri@nursing.osakafu-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
大阪府立大学
四條畷学園
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 25 | Day |
Related information
URL releasing protocol
https://www.pagepress.org/journals/index.php/dr/article/view/9711
Publication of results
Unpublished
Result
URL related to results and publications
https://www.pagepress.org/journals/index.php/dr/article/view/9711
Number of participants that the trial has enrolled
37
Results
SC hydration (Mean) of the intervention group after 8 weeks from the start changed from 39.2 to 42.4, while in the control group it changed from 43.1 to 40.4. Analysis showed a trend towards higher SC hydration in the intervention group compared to the control group.
TEWL from the start to 8 weeks later ranged from 5.2 to 6.0 in the intervention group and from 5.8 to 6.8 in the control group. There was no difference.
Results date posted
| 2023 | Year | 10 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In the intervention group, participants were recruited from new members of three gyms. It was expected that new gym members would be highly motivated to exercise. In the control group, participants were recruited from two universities. Study participants were recruited on the condition that they did not currently have regular exercise habits.
Exclusion criteria were being pregnant, being 6 months postpartum, having history of chronic skin disease, and smoking.
Participant flow
The study procedures in the intervention group were as follows.
(1) A space in the gym was secured to avoid the influence of airflow, and the room temperature and humidity were checked.
(2) At the beginning of the study, basic information, lifestyle, and activity level of participants were obtained using a questionnaire.
(3) SC hydration and TEWL were measured.
(4) Exercise to meet the criteria for regular exercise was discussed with the participants.
(5) Participants were asked to exercise according to the determined exercise program and to record their daily exercise in an exercise diary.
(6) Once every two weeks, we sent e-mails to participants to confirm their exercise status.
(7) Eight weeks later, participants' lifestyle and activity levels were ascertained through an interview, and SC hydration and TEWL were measured.
The study procedures in the control group were as follows:
(1) A space in the university was secured to avoid the influence of airflow, and the room temperature and humidity were checked.
(2) At the beginning of the study, basic information, lifestyle, and activity level of participants were obtained using a questionnaire.
(3) SC hydration and TEWL were measured.
(4) Participants were asked to maintain their current lifestyle.
(5) Eight weeks later, participants' lifestyle and activity levels were ascertained through an interview, and SC hydration and TEWL were measured.
Adverse events
none
Outcome measures
stratum corneum hydration (SC hydration) and Trans-Epidermal Water Loss (TEWL)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 22 | Day |
Last modified on
| 2023 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048182
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