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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045585
Receipt No. R000052046
Scientific Title Effects of exercise on the pathophysiology of atopic dermatitis
Date of disclosure of the study information 2021/10/01
Last modified on 2021/09/28

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Basic information
Public title Effects of exercise on the pathophysiology of atopic dermatitis
Acronym Exercise and atopic dermatitis
Scientific Title Effects of exercise on the pathophysiology of atopic dermatitis
Scientific Title:Acronym Exercise and atopic dermatitis
Region
Japan

Condition
Condition atopic dermatitis
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the efficacy of moderate exercise on the skin barriers and the pathophysiology of atopic dermatitis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The severity of atopic dermatitis is assessed by dermatologists at pre- and post-trial.
Key secondary outcomes Physical activity, Blood biomarker, Skin barriers, Sweating, Self-assessment of the severity of atopic dermatitis

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Running group carries out running exercise at 65%HRR for 30 min/day, three times per week, for 12 weeks.
Interventions/Control_2 Walking group carries out brisk walking exercise for 30 min/day, five times per week, for 12 weeks.
Interventions/Control_3 Control group performs normal daily activities for 12 weeks.
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
50 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients with atopic dermatitis.
2. Male and female aged from 20 to 49 years old.
3. Patients who can agree to participate in the study voluntarily in writing.
Key exclusion criteria 1. Patients with disabling orthopedic or medical disorder.
2. Pregnant female and female suspected of being pregnant.
3. Patients who continue to train hard.
4. Patients who are judged inadequate to participate the study by the principal investigator.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name Nobuhiko
Middle name
Last name Eda
Organization Dokkyo Medical University
Division name Department of Fundamental Education
Zip code 321-0293
Address 880 Kitakobayashi, Mibu, Shimotsugagun, Tochigi 321-0293, Japan
TEL 0282-87-2119
Email n-eda@dokkyomed.ac.jp

Public contact
Name of contact person
1st name Nobuhiko
Middle name
Last name Eda
Organization Dokkyo Medical University
Division name Department of Fundamental Education
Zip code 321-0293
Address 880 Kitakobayashi, Mibu, Shimotsugagun, Tochigi 321-0293, Japan
TEL 0282-87-2119
Homepage URL
Email n-eda@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Dokkyo Medical University Hospital
Address 880 Kitakobayashi, Mibu, Shimotsugagun, Tochigi 321-0293, Japan
Tel 0282-87-2275
Email r-kenkyu@dokkyomed.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
2021 Year 10 Month 01 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
2021 Year 09 Month 14 Day
Date of IRB
Anticipated trial start date
2021 Year 10 Month 01 Day
Last follow-up date
2022 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
2021 Year 09 Month 28 Day
Last modified on
2021 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052046

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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