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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016363
Receipt No. R000018960
Scientific Title The analysis of related factors of physical activity and the effects of medical interventions in patients with COPD
Date of disclosure of the study information 2015/02/01
Last modified on 2020/02/12

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Basic information
Public title The analysis of related factors of physical activity and the effects of medical interventions in patients with COPD
Acronym Analysis of physical activity and the effects of intervention in COPD
Scientific Title The analysis of related factors of physical activity and the effects of medical interventions in patients with COPD
Scientific Title:Acronym Analysis of physical activity and the effects of intervention in COPD
Region
Japan

Condition
Condition COPD
healthy adults (for the validation of accelerometer)
Classification by specialty
Pneumology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyze the factors that define physical activity and to evaluate the effects of medical interventions on physical activity in patients with COPD
Basic objectives2 Others
Basic objectives -Others exploration and efficacy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) the duration of physical activity at more than 3.0METs
2) average intensity of physical activity (METs´Żąhr at more than 3.0METs)
Key secondary outcomes 1) the duration of physical activity at more than 3.0METs
2) the total steps/day
3) the duration of physical activity at 1.0-1.5METs

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
40 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria FEV1/FVC < 0.7

(Healthy subjects aged 20 years or more are included for the validation of accelerometer.)
Key exclusion criteria (1) patients whose physical activities are suppressed by diseases other than COPD
(2) patients who received pulmonary rehabilitation among 6 weeks before the entry
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yoshiaki
Middle name
Last name Minakata
Organization National Hospital Organization Wakayama Hospital
Division name Department of Respiratory Medicine
Zip code 644-0044
Address 1138 Wada Mihama-cho, Hidaka-gun, Wakayama 644-0044, Japan
TEL 0738-22-3256
Email minakata.yoshiaki.qy@mail.hosp.go.jp

Public contact
Name of contact person
1st name Yoshiaki
Middle name
Last name Minakata
Organization National Hospital Organization Wakayama Hospital
Division name Department of Respiratory Medicine
Zip code 644-0044
Address 1138 Wada Mihama-cho, Hidaka-gun, Wakayama 644-0044, Japan
TEL 0738-22-3256
Homepage URL
Email minakata.yoshiaki.qy@mail.hosp.go.jp

Sponsor
Institute National Hospital Organization Wakayama Hospital
Institute
Department

Funding Source
Organization none
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 Ethics Committee of National Hospital Organization Wakayama Hospital
Address 1138 Wada Mihama-cho, Hidaka-gun, Wakayama 644-0044, Japan
Tel 0738223256
Email fukuda.toshiaki.gm@mail.hosp.go.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
2015 Year 02 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
2014 Year 09 Month 08 Day
Date of IRB
2014 Year 10 Month 31 Day
Anticipated trial start date
2015 Year 02 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The physical activity evaluated by triaxial accelerometer is compared with demographic factors, physiological factors, and the factors related to co-morbidities. Then the effects of medical interventions, including bronchodilators, pulmonary rehabilitation, behavior modification, and/or flying disc game, on physical activity in patients with COPD are investigated.

Management information
Registered date
2015 Year 01 Month 28 Day
Last modified on
2020 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018960

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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