UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023586 |
|---|---|
| Receipt number | R000024678 |
| Scientific Title | Effect of both LAMA/LABA and smart watch for COPD patient about physical activity. |
| Date of disclosure of the study information | 2016/08/11 |
| Last modified on | 2019/03/27 13:59:39 |
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Basic information
Public title
Effect of both LAMA/LABA and smart watch for COPD patient about physical activity.
Acronym
Matsusaka municipal hospital COPD study.
Scientific Title
Effect of both LAMA/LABA and smart watch for COPD patient about physical activity.
Scientific Title:Acronym
Matsusaka municipal hospital COPD study.
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We are planning to conduct a test to see if physical activity will improve or not as we use LAMA/LABA and smart watch simultaneously.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will evaluate physical activity using accelerator.
Key secondary outcomes
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Applewatch
Tiotropium olodaterol mix
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)A Patient who is visiting our outpatient clinic, is over 40 years of age, and has smoking history
2)A patient who is classified into the second or third stage of COPD in pulmonary function test.
3)A patient who smoke 1 pack per day for 10 years or more
4)A patient who agreed to participate in the study with the written informed consent
Key exclusion criteria
1)A patient who cannot be performed a respiratory function test appropriately
2) A patient whom the doctor in charge judged unsuitable as subjected is excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Hataji |
Organization
Matsusaka Municipal Hospital
Division name
Respiratory Center
Zip code
5150073
Address
1550 Tonomachi,Matsusaka,Mie,515-8544,Japan
TEL
0598-23-1515
mch1031@city-hosp.matsusaka.mie.jp
Public contact
Name of contact person
| 1st name | Kie |
| Middle name | |
| Last name | Okamoto |
Organization
Matsusaka Municipal Hospital
Division name
Respiratory Center
Zip code
5150073
Address
1550 Tonomachi,Matsusaka,Mie,515-8544,Japan
TEL
0598-23-1515
Homepage URL
mchkuraguchi@city-hosp.matsusaka.mie.jp
Sponsor or person
Institute
Matsusaka Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Matsusaka Municipal Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Matsusaka municipal hospital
Address
1550 Tonomachi Matsusaka Mie Japan
Tel
0509231515
mch1031@city-hosp.matsusaka.mie.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
| 2016 | Year | 08 | Month | 11 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5658686/
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5658686/
Number of participants that the trial has enrolled
20
Results
The mean number of steps and the mean energy expended in kilocalories for all patients were significantly
increased following treatment compared to the mean
values before treatment.
Results date posted
| 2019 | Year | 03 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
COPD patients
GOLD 2 11
GOLD3 9
Participant flow
Explained Matsusaka municipal Hospital outpatients
Adverse events
non
Outcome measures
CAT
6MWT
FEV1
Physical activity level
steps
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 27 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 27 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 10 | Day |
Last modified on
| 2019 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024678
| Research Plan | |
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| Registered date | File name |
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