UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000023586
Receipt No. 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 (Ver. 6)

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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
Last 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
Email mch1031@city-hosp.matsusaka.mie.jp

Public contact
1st 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
Email mchkuraguchi@city-hosp.matsusaka.mie.jp

Sponsor
Institute Matsusaka Municipal Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024678