UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030580 |
|---|---|
| Receipt number | R000034919 |
| Scientific Title | Open label, multicenter trials, non-randomized, single arm, distribution-free test to verify the effectiveness about remote support using a smartphone for keeping physical activity on persons with chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2017/12/27 |
| Last modified on | 2022/06/30 10:56:09 |
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Basic information
Public title
Open label, multicenter trials, non-randomized, single arm, distribution-free test to verify the effectiveness about remote support using a smartphone for keeping physical activity on persons with chronic obstructive pulmonary disease
Acronym
Effectiveness verification about remote support using a smartphone for securing physical activity on persons with chronic obstructive pulmonary disease
Scientific Title
Open label, multicenter trials, non-randomized, single arm, distribution-free test to verify the effectiveness about remote support using a smartphone for keeping physical activity on persons with chronic obstructive pulmonary disease
Scientific Title:Acronym
Effectiveness verification about remote support using a smartphone for securing physical activity on persons with chronic obstructive pulmonary disease
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A researcher said the rate of exercise practicers with COPD is lower. To foster exercise habits of home care patients with COPD, we executed to develop a physical activity support system by remote. The purpose of the study is that effectiveness verification about a physical activity support system using a smartphone for fostering exercise habits and preservation of COPD patients' fitness level.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Variation of the amount of physical activity by intervention in the remote health support during 6 months. The amount of physical activity is measured by a pedometer.
Key secondary outcomes
Fitness level by intervention in the remote health support during 6 months. Fitness level is measured by the method of 6-minute walking test.
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
| Behavior,custom |
Interventions/Control_1
Single arm test. The evaluations about the amount of physical activity and 6-min walking test are executed before interventions on patients with COPD. After these, we start to intervene that to support their physical activity using a smartphone. We measure their daily walking distance and steps everyday by smartphones, and then sent them feedback messages to their smartphones. The term of interventions is 6 months. After 6 months intervention, the evaluations about the amount of physical activity and 6-min walking test are re-executed. We compare change of the data about physical activities and fitness level between pre-post interventions.
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
Over 20-year-old patient with COPD. He/she has a medical examination once a month in National Hospital Organization East Nagano Hospital and keep the steadiness of their disease condition at home. Furthermore, he/she is a parson, who is admitted the eligibility to attend the research by their doctors.
Key exclusion criteria
As shown below the parson is excluded as a subject of the study.
1)The disease condition of being dangerously illness and the living activities are considerably constrained.
2)It is necessary to monitor or attend when enforcing exercise.
3)Restraining exercise or physical activities for the reason of other injury and disease.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Chisato |
| Middle name | |
| Last name | Ohashi |
Organization
National Institute of Technology, Toyama College
Division name
Department of General Education
Zip code
9330957
Address
1-2 Ebieneriya, Imizu, Toyama, Japan
TEL
0766-86-5201
c-ohashi@nc-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Chisato |
| Middle name | |
| Last name | Ohashi |
Organization
National Institute of Technology, Toyama College
Division name
Department of General Education
Zip code
9330957
Address
1-2 Ebieneriya, Imizu, Toyama, Japan
TEL
0766-86-5201
Homepage URL
c-ohashi@nc-toyama.ac.jp
Sponsor or person
Institute
National Institute of Technology, Toyama College
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Hospital Organization East Nagano Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institute of Technology, Toyama College
Address
1-2 Ebieneriya Imizu Toyama Japan
Tel
0766-86-5201
c-ohashi@nc-toyama.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
国立病院機構 東長野病院、飯綱町立飯綱病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
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
| 2017 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 26 | Day |
Last modified on
| 2022 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034919
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/01/04 | 研究計画書20210105.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2021/01/04 | 研究症例データ仕様書.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/01/04 | 研究症例データ.pdf |
