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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030580
Receipt No. 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 2019/07/11

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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
Email 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
Email c-ohashi@nc-toyama.ac.jp

Sponsor
Institute National Institute of Technology, Toyama College
Institute
Department

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
Email 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 Partially 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 No longer recruiting
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 26 Day
Last modified on
2019 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034919

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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