UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032100 |
|---|---|
| Receipt number | R000036602 |
| Scientific Title | Physical activity in patients with chronic obstructive pulmonary disease 1 year after pulmonary rehabilitation |
| Date of disclosure of the study information | 2018/04/30 |
| Last modified on | 2022/10/07 20:51:28 |
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Basic information
Public title
Physical activity in patients with chronic obstructive pulmonary disease 1 year after pulmonary rehabilitation
Acronym
Physical activity in patients with chronic obstructive pulmonary disease 1 year after pulmonary rehabilitation
Scientific Title
Physical activity in patients with chronic obstructive pulmonary disease 1 year after pulmonary rehabilitation
Scientific Title:Acronym
Physical activity in patients with chronic obstructive pulmonary disease 1 year after pulmonary rehabilitation
Region
| Japan |
Condition
Condition
chronic obstructive lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the physical activity(PA) of patients with COPD after pulmonary rehabilitation program(PRP), and consider whether PA will be maintain at monthly follow-up
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity 1year after pulmonary rehabilitation program
Key secondary outcomes
Body mass index, age, severity, grip, leg muscle strength, 6 minutes walking distance, COPD assessment test, visual analog scale-8, Hospital Anxiety and Depression Scale, oxygen cost diagram, modified Medical Research Council, The Nagasaki University Respiratory ADL questionnaire, before and after PRP, 6 month after PRP, and 1 year after PRP.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Physical activity measurement by pedometer (every day during 8 weeks of PRP, 6 months after follow-up and 1 month after 1 year each day)
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
| 60 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patient diagnosed with COPD who is visiting respiratory department at the Tokyo Women's Medical University Yachiyo Medical Center or respiratory medicine department at Chiba University Hospital
2. Patients who are over 50 years of age at consent acquisition
3. Patients who are considered to be able to go to hospital for the monthly follow-up after completion of outpatient PRP (visit every week) for 8 weeks
4. Patients whose daily living is independent
5. Patient judged by researcher or assignee (hereinafter referred to as research staff) who can accurately perform respiratory function test
6. After receiving sufficient explanation for participation in this study, patients who gained written consent by the patient's free will with sufficient understanding
Key exclusion criteria
1. Patients who are restricted in activity due to severe orthopedic disease or central nervous system disease
2. Patients who have been judged by the research staff to have unstable heart disease
3. Patients with a history of other serious lung diseases such as occupational lung, sarcoidosis, airway hyperresponsiveness, malignancy, pulmonary infection due to immunodeficiency
4. Patients with collagen disease
5. Other patients who are deemed inappropriate as research subjects by research staff
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Katsura |
Organization
Tokyo Women's Medical University Yachiyo Medical Center
Division name
Division of Rehabilitation
Zip code
2768524
Address
477-96, Owadashinden, Yachiyo city, Chiba, Japan
TEL
047-450-6000
katsura.hideki@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Soh |
| Middle name | |
| Last name | Imamura |
Organization
Tokyo Women's Medical University Yachiyo Medical Center
Division name
Department of rehabilitation
Zip code
2768524
Address
477-96, Owadashinden, Yachiyo city, Chiba, Japan
TEL
047-450-6000
Homepage URL
imamura.so@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University Yachiyo Medical Center respiratory medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chiba University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University Yachiyo Medical Center
Address
477-96, Owadashinden, Yachiyo city, Chiba, Japan
Tel
047-450-6000
imamura.so@twmu.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
東京女子医科大学八千代医療センター，千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 04 | Day |
Last modified on
| 2022 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036602
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
