UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039821 |
|---|---|
| Receipt number | R000045388 |
| Scientific Title | Improving dyspnea and physical activity by sending wind to a face with a fan |
| Date of disclosure of the study information | 2020/03/16 |
| Last modified on | 2023/09/16 00:59:33 |
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Basic information
Public title
Improving dyspnea and physical activity by sending wind to a face with a fan
Acronym
Dyspnea and Fan
Scientific Title
Improving dyspnea and physical activity by sending wind to a face with a fan
Scientific Title:Acronym
Dyspnea and Fan
Region
| Japan |
Condition
Condition
Dyspnea
Classification by specialty
| Pneumology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify that dyspnea decreases and physical activity increases when the patient sends air to a face with an electric fan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual analog scale of dyspnea and MRC scale after three weeks of using a fan.
Key secondary outcomes
PASE:Physical activity for elderly, Health related QOL(SF-12, VAS-8), HAD:Hospital anxiety and depression scale, after three weeks of using a fan.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Blowing one's face by an electric fan for about three weeks.
A(Using a fan five to ten times a day)
Interventions/Control_2
Blowing one's face by an electric fan for about three weeks.
B(Using a fan one to two times a day)
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
Patients with mild dyspnea due to chronic condition.
Out patients who have modified MRC scale Grade2(On level ground, I walk slower than people of the same age because of breathlessness, or I have to stop for breath when walking at my own pace on the level) or grater dyspnea.
Include patients who are not clearly recognize their ADL: activity of daily living, had been affected by dyspnea.
Target disease
Malignant tumor:
primary lung cancer, metastatic lung cancer
Chronic respiratory disease:
COPD (chronic obstructive pulmonary disease), ACO (overlap of asthma and COPD) interstitial pneumonia, etc.
And Chronic heart failure.
Key exclusion criteria
Under 20 years old.
Hospitalization due to exacerbation of respiratory failure within the past 4 weeks, and addition of oral steroids, or administration of antibiotics
Patients who cannot properly answer the questionnaire survey due to cognitive problems
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Miyagawa |
Organization
Showa University
Graduate School of Health Sciences
Division name
Internal Medicine and Rehabilitation Science
Zip code
226-8555
Address
1865 Toukaichiba-cho, Midori-ku, Yokohama-City, Kanagawa, Japan
TEL
045-985-6543
miyagawa@nr.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideko |
| Middle name | |
| Last name | Nagumo |
Organization
University of Tokyo Health Sciences
Division name
Faculty of Health Sciences, Department of Nursing
Zip code
206-0033
Address
4-11 Ochiai, Tama-City, Tokyo, Japan
TEL
042-373-8118
Homepage URL
h-nagumo@u-ths.ac.jp
Sponsor or person
Institute
Showa University
Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Showa University
Graduate school of Health Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tokyo Health Sciences, IRB, Sugimoto Satoshi
Address
4-11, Ochiai, Tama-City, Tokyo, Japan
Tel
042-373-8118
s-sugimoto@u-ths.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
もとき内科クリニック（神奈川県）、いきいきクリニック（神奈川県）、日本医科大学武蔵小杉病院（神奈川県）、湘南鎌倉総合病院(神奈川県)、大阪市立総合医療センター（大阪府）、大垣市民病院（岐阜県）、霧が丘つだ病院（福岡県）、アカラクリニック（神奈川県）
Motoki Medical Clinic(Kanagawa), Ikiiki Clinic(Kanagawa), Nippon Medical School Musashikosugi Hospital(Kanagawa), Shonankamakura General Hospital(Kanagawa), Osaka City General Hospital(Osaka)、 Oogaki Municipal Hospital(Gifu)、Kirigaoka-Tsuda Hospital(Fukuoka)、Akara Clinic(Kanagawa)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 16 | 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
36
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to COVID-19 countermeasures at multiple facilities, the ethics committee review was delayed.
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
| 2020 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 14 | Day |
Last modified on
| 2023 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045388
