UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027220 |
|---|---|
| Receipt number | R000031188 |
| Scientific Title | The analysis of the safety and the effect of pursed-lip breathing in patients with chronic obstructive pulmonary disease (COPD) on playing flying disk for improvement of physical activity |
| Date of disclosure of the study information | 2017/05/03 |
| Last modified on | 2019/11/14 09:48:08 |
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Basic information
Public title
The analysis of the safety and the effect of pursed-lip breathing in patients with chronic obstructive pulmonary disease (COPD) on playing flying disk for improvement of physical activity
Acronym
The analysis of the safety and the effect of pursed-lip breathing in COPD on playing flying disk
Scientific Title
The analysis of the safety and the effect of pursed-lip breathing in patients with chronic obstructive pulmonary disease (COPD) on playing flying disk for improvement of physical activity
Scientific Title:Acronym
The analysis of the safety and the effect of pursed-lip breathing in COPD on playing flying disk
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the effect of pursed-lip breathing after evaluating changes of heart rate(HR) and oxygen saturation(SpO2) on playing flying disk in patients with chronic obstructive pulmonary disease (COPD)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
chenges of SpO2, breathing with pursed-lip on playing flying disk
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
pursed-lip breathing
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
FEV1.0/FVC<0.7
Key exclusion criteria
1)exacerbations in 3 months
2)difficulty of standing or sitting by themselves
3)moving limitation on the arm
4)SpO2<88% on walking, with or without oxygen therapy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Hayata |
Organization
Wakayama Medical University
Division name
Third Department of internal Medicine
Zip code
641-8509
Address
811-1 kimiidera, Wakayama 641-8509 Japan
TEL
073-441-0619
atsushih@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Hayata |
Organization
Wakayama Medical University
Division name
Third Department of internal Medicine
Zip code
641-8509
Address
811-1 kimiidera, Wakayama 641-8509 Japan
TEL
073-441-0619
Homepage URL
atsushih@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
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
Wakayama Medical University
Address
811-1 Kimiidera Wakayama 641-8509 Japan
Tel
073-441-0619
atsushih@wakayama-med.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
25
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
| 2017 | Year | 05 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 02 | Day |
Last modified on
| 2019 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031188
