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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033582
Receipt No. R000038283
Scientific Title Effect of 6-month rehabilitation with low loading program and a self-managed physical activity program using a pedometer for chronic respiratory disease:A clinical trial.
Date of disclosure of the study information 2018/08/01
Last modified on 2019/10/25

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Basic information
Public title Effect of 6-month rehabilitation with low loading program and a self-managed physical activity program using a pedometer for chronic respiratory disease:A clinical trial.
Acronym Effect of 6-month rehabilitation with low loading program and a self-managed physical activity program using a pedometer for chronic respiratory disease:A clinical trial.
Scientific Title Effect of 6-month rehabilitation with low loading program and a self-managed physical activity program using a pedometer for chronic respiratory disease:A clinical trial.
Scientific Title:Acronym Effect of 6-month rehabilitation with low loading program and a self-managed physical activity program using a pedometer for chronic respiratory disease:A clinical trial.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the effects of rehabilitation with low loading program teaching home-based physical exercise and a self-managed activity program using a pedometer and diary method on physical function, activities of dairy living(ADL), and quality of life(QOL) in patients with chronic respiratory disease.
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 Lung function, Isometoric knee extensiton strength, St George's Respiratory Questionnaire(SGRQ), Modified MRC dyspnea scale, COPD Assessment scale(CAT), The Nagasaki University Respiratory ADL questionnaire(NRADL), 30-second chair-stand test, Average number of steps a day

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 We teach home-based physical exercises to patients.Patients record the number of steps and self-evaluation of physical activity in a diary every day.We prompt them to increase 5% of the average number of steps in 1 month every month.Thease intervention will be held for 6 months.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The chronic respiratory disease patients visiting Jobu Hospital for Respiratory Disease.
The patients going to hospital regularly.
The patients who agreed in written to join this clinical trial.
Key exclusion criteria The patients have any of sever 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 disease, bronchial asthma, graphia or dementia.
Target sample size 30

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

Public contact
Name of contact person
1st name
Middle name
Last name Daigo Kato
Organization Jobu hospital for respiratory diseases
Division name Dapartment of rihabilitation
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 08 Month 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 07 Month 05 Day
Date of IRB
2018 Year 07 Month 25 Day
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2021 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 01 Day
Last modified on
2019 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038283

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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