UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of physical activity self-management program using a pedmeter in chronic respiratory diseases (CRD)
Title of the study (Brief title)	The effects of physical activity self-management program using a pedmeter in chronic respiratory diseases (CRD)
Region	Japan

Condition
Condition	Chronic respiratory diseases
Classification by specialty	Pneumology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of physical activity self-management program using a pedometer and diary method on physical and lung function in CRD patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	6-Minute Walk Test (6MWT)
Key secondary outcomes	SpO2, Lung function, Isometric knee extension strength, St.George's Respiratory Questionnaire(SGRQ), COPD Assessment Test(CAT), The Nagasaki University Respiratory ADL questionnaire(NRADL)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Patients record the number of steps and self-evaluation of physical activity level in a diary.
Interventions/Control_2	Neither use an odograph nor keep a diary.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	CLD patients visiting Jobu Hospital for Respiratory Diseases. The patients going to hospital regularly. The patients who agreed in written to join this clinical trial.
Key exclusion criteria	Patient have any of severe heart, medical or orthopedic diseases and has judged by the treating physician to be inappropriate to participate in the study. The patients with acute diseases, malignant diseases, bronchial asthma, agraphia or dementia.
Target sample size	60

Research contact person
Name of lead principal investigator	Daigo Kato
Organization	Jobu hospital for respiratory diseases
Division name	Department of rehabilitation
Address	586-1, taguchi, Maebashi, Gunma, JAPAN
TEL	027-232-5000
Email	katod.rpt@gmail.com

Public contact
Name of contact person	Daigo Kato
Organization	Jobu hospital for respiratory diseases
Division name	Department of rehabilitation
Address	586-1, taguchi, Maebashi, Gunma, JAPAN
TEL	027-232-5000
Homepage URL
Email	katod.rpt@gmail.com

Sponsor
Institute	Jobu hospital for respiratory diseases
Institute
Department

Funding Source
Organization	Non
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 07 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 28 Day
Anticipated trial start date	2013 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 23 Day
Last modified on	2017 Year 01 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020366