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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000022234
Receipt No. R000025607
Scientific Title Effects of breathing accompanied the trunk movement has on the respiratory function and respiratory muscle strength
Date of disclosure of the study information 2016/05/07
Last modified on 2017/05/16

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Basic information
Public title Effects of breathing accompanied the trunk movement has on the respiratory function and respiratory muscle strength
Acronym Trunk movement and breathing
Scientific Title Effects of breathing accompanied the trunk movement has on the respiratory function and respiratory muscle strength
Scientific Title:Acronym Trunk movement and breathing
Region
Japan

Condition
Condition Esophageal cancer
Lung cancer
Healthy individual
Classification by specialty
Gastrointestinal surgery Chest surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study, by performing the breathing accompanied by trunk motion, consider the changes in respiratory function and respiratory muscle strength.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Respiratory function
vital capacity;VC,%VC,forced vital capacity;FVC,%FVC,forced expiratory volume in one second;FEV1,FEV1%G,peak expiratory flow;PEF,%PEF
Key secondary outcomes Respiratory muscle strength
maximum expiratory pressure;MEP,%MEP,maximum inspiratory pressure;MIP,%MIP

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Implementation period:2 days
Machine:Fukuda Denshi Spiro Sift SP-370COPD lung pre plus
Attitude holding group gazing at the front, carried out without removing the back from the backrest.
Interventions/Control_2 Trunk exercise group performs a trunk kyphosis movement at the time of maximum exhalation. Carry out the trunk and extension movements at the time of maximum inspiration.
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patient lung cancer
Patient esophageal cancer
Patients capable of obtaining the consent of the research participation by free will in writing from the person
Key exclusion criteria dementia
giant lung cyst
pneumothorax
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name yasuaki Nozawa
Organization Okayama University Hospital
Division name General Department of Rehabilitation
Zip code
Address Okayamasi Kitaku Sikatachou 2-5-1
TEL 086-235-7752
Email n_yasu0626@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name yasuaki Nozawa
Organization Okayama University Hospital
Division name General Department of Rehabilitation
Zip code
Address Okayamasi Kitaku Sikatachou 2-5-1
TEL 086-235-7752
Homepage URL
Email n_yasu0626@yahoo.co.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 05 Month 07 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 05 Month 07 Day
Last modified on
2017 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025607

Research Plan
Registered date File name
2017/05/16 研究計画書.docx

Research case data specifications
Registered date File name
2017/05/16 仕様書.pptx

Research case data
Registered date File name
2017/05/16 結果.pptx


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