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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027220
Receipt No. 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

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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
Email 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
Email atsushih@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
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 Wakayama Medical University
Address 811-1 Kimiidera Wakayama 641-8509 Japan
Tel 073-441-0619
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031188

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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