UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035677 |
|---|---|
| Receipt number | R000040640 |
| Scientific Title | Investigation of the effect of exercise tolerance decline after lung resection on the prognosis |
| Date of disclosure of the study information | 2019/01/25 |
| Last modified on | 2019/01/25 22:18:14 |
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Basic information
Public title
Investigation of the effect of exercise tolerance decline after lung resection on the prognosis
Acronym
Investigation of the effect of exercise tolerance decline after lung resection on the prognosis
Scientific Title
Investigation of the effect of exercise tolerance decline after lung resection on the prognosis
Scientific Title:Acronym
Investigation of the effect of exercise tolerance decline after lung resection on the prognosis
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigation of the effect of exercise tolerance decline after lung resection on the prognosis
Basic objectives2
Others
Basic objectives -Others
Prognosis
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
- a length of time from surgery to hospital readmission
Key secondary outcomes
- a length of time from surgery to death
- 6-minute walk distance at before and after surgical operation
- grip at before and after surgical operation
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
| 43 | years-old | <= |
Age-upper limit
| 86 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases that received a lung resection in lung cancer and experienced rehabilitation program by physical therapist in our hospital
Key exclusion criteria
Cases that could not be performed 6-minute walk test before and after surgery operation
Target sample size
99
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruki Maniwa |
Organization
Matsue Red Cross Hospital
Division name
Rehabilitation
Zip code
Address
200, Horo, Matsue, Shimane, Japan
TEL
0852-24-2111
maniwa_h@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruki Maniwa |
Organization
Matsue Red Cross Hospital
Division name
Rehabilitation
Zip code
Address
200, Horo, Matsue, Shimane, Japan
TEL
0852-24-2111
Homepage URL
maniwa_h@yahoo.co.jp
Sponsor or person
Institute
Matsue Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
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
| 2019 | Year | 01 | Month | 25 | 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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | 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
We analyzed 99 samples. We indicated that the 6-minute walk distance shortening of 30m or more after lung resection compared pre-surgery affects hospital readmission within 1 year after surgery.
Management information
Registered date
| 2019 | Year | 01 | Month | 25 | Day |
Last modified on
| 2019 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040640
