UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016363 |
|---|---|
| Receipt number | 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 | 2023/02/03 17:04:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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･hr 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
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
minakata.yoshiaki.qy@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Wakayama Hospital
Institute
Department
Personal name
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
inoue.atsuyuki.nx@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
| 2025 | 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
| 2023 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.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 |
