UMIN-CTR Clinical Trial

Basic information
Public title	The effect of wearing a pedometer on daily steps in patients with choronic respiratory disease
Acronym	The effect of wearing a pedometer on daily steps in patients with choronic respiratory disease
Scientific Title	The effect of wearing a pedometer on daily steps in patients with choronic respiratory disease
Scientific Title:Acronym	The effect of wearing a pedometer on daily steps in patients with choronic respiratory disease
Region	Japan

Condition
Condition	chronic respiratory disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We targeted patients with chronic respiratory disease. Using the pedometer provided, enter the daily step count, which is one of the daily physical activities, into a diary and observe whether the initial step count can be maintained or increased.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	daily steps and quality of life
Key secondary outcomes	quality of life and respiratory function

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Chronic respiratory disease over 20 years Can walk
Key exclusion criteria	unable to walk
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masato Middle name Last name Muraki
Organization	Kindai University Nara Hospital
Division name	Department of Respiratory Medicine and Allergology
Zip code	630-0293
Address	1248-1 Otoda-cho, Ikoma, Nara
TEL	0743-77-0880
Email	muraki-m@med.kindai.ac.jp

Public contact
Name of contact person	1st name Masato Middle name Last name Muraki
Organization	Kindai University Nara Hospital
Division name	Department of Respiratory Medicine and Allergology
Zip code	630-0293
Address	1248-1 Otoda-cho, Ikoma, Nara
TEL	0743-77-0880
Homepage URL
Email	muraki-m@med.kindai.ac.jp

Sponsor
Institute	Kindai University Nara Hospital Department of Respiratory Medicine and Allergology
Institute
Department

Funding Source
Organization	Kindai University Nara Hospital Department of Respiratory Medicine and Allergology
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	Kindai University Nara Hospital
Address	1248-1 Otoda-cho, Ikoma, Nara
Tel	0743-77-0880
Email	muraki-m@med.kindai.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

Other administrative information
Date of disclosure of the study information	2020 Year 08 Month 17 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
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	Open public recruiting
Date of protocol fixation	2016 Year 06 Month 27 Day
Date of IRB	2016 Year 06 Month 27 Day
Anticipated trial start date	2016 Year 06 Month 28 Day
Last follow-up date	2021 Year 06 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	observation of daily steps and QOL

Management information
Registered date	2020 Year 08 Month 17 Day
Last modified on	2020 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047315