UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022234 |
|---|---|
| Receipt number | 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 19:26:50 |
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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
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
n_yasu0626@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
