UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018404 |
|---|---|
| Receipt number | R000020366 |
| Scientific Title | The effects of physical activity self-management program using a pedmeter in chronic respiratory diseases (CRD) |
| Date of disclosure of the study information | 2015/07/24 |
| Last modified on | 2017/01/22 13:55:36 |
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Basic information
Public title
The effects of physical activity self-management program using a pedmeter in chronic respiratory diseases (CRD)
Acronym
The effects of physical activity self-management program using a pedmeter in chronic respiratory diseases (CRD)
Scientific Title
The effects of physical activity self-management program using a pedmeter in chronic respiratory diseases (CRD)
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Daigo Kato |
Organization
Jobu hospital for respiratory diseases
Division name
Department of rehabilitation
Zip code
Address
586-1, taguchi, Maebashi, Gunma, JAPAN
TEL
027-232-5000
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
Department of rehabilitation
Zip code
Address
586-1, taguchi, Maebashi, Gunma, JAPAN
TEL
027-232-5000
Homepage URL
katod.rpt@gmail.com
Sponsor or person
Institute
Jobu hospital for respiratory diseases
Institute
Department
Personal name
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
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 |
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
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 28 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020366
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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