UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039960 |
|---|---|
| Receipt number | R000045561 |
| Scientific Title | the effects of supplemental oxygen therapy during exercise training in patients with chronic obstructive pulmonary disease: systematic review and meta-analysis |
| Date of disclosure of the study information | 2020/03/27 |
| Last modified on | 2022/04/19 09:17:47 |
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Basic information
Public title
the effects of supplemental oxygen therapy during exercise training in patients with chronic obstructive pulmonary disease: systematic review and meta-analysis
Acronym
the effects of supplemental oxygen therapy during exercise training in patients with chronic obstructive pulmonary disease: systematic review and meta-analysis
Scientific Title
the effects of supplemental oxygen therapy during exercise training in patients with chronic obstructive pulmonary disease: systematic review and meta-analysis
Scientific Title:Acronym
the effects of supplemental oxygen therapy during exercise training in patients with chronic obstructive pulmonary disease: systematic review and meta-analysis
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this meta-analysis is to elucidate whether supplemental oxygen therapy during exercise traning has efficacy in patients with on chronic obstructive pulmonary disease (COPD).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
6-minute walking distance,
shuttle walking distance
Key secondary outcomes
Borg scale
maximum work rate of exercise training
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with chronic obstructive pulmonary disease
Key exclusion criteria
none
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Shohei |
| Middle name | |
| Last name | Kawachi |
Organization
Shinshu University
Division name
Graduate school of medicine science and technology
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto sity, Nagano, Japan
TEL
0263372393
18hm205e@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Kawachi |
Organization
Shinshu University
Division name
Graduate school of medicine science and technology
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto sity, Nagano, Japan
TEL
0263-37-2393
Homepage URL
18hm205e@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu 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
None
Address
None
Tel
0263-37-2572
mdrinri@shinshu-u.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
| 2020 | Year | 03 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A systematic search of the literature is conducted according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) Statement. We search for studies with inceptions up to 3 2020 in the following electronic databases: Cochrane Central Register of Controlled Trials (CEN-TRAL), MEDLINE, and EMBASE. The search was conducted using terms 'COPD', 'supplemental','oxygen therapy'. Hand search is taken for additional eligible studies. No language restrictions are applied.
We inclued all randomized controlled trials (RCTs) that evaluated the efficacy of combined exercise training and oxygen therapy with COPD.
Studies eligible for inclusion will meet all of the following criteria: (1) study design is an RCT; (2) study involve patients with confirmed COPD; (3) study compare the exercise trainig combined oxygen therapy with placebo gas or no oxygen therapy ; (4) study reported on at least one of the outcome measures.
SK and SY independently assess the quality of each study with the risk of bias tool in the Cochrane Handbook for Systematic Reviews of Interventions.
Participants are divided into two groups; combined exercise training with oxygen therapy and control group including placebo gas or no oxygen therapy. Duration and intensity are not limited.
Management information
Registered date
| 2020 | Year | 03 | Month | 27 | Day |
Last modified on
| 2022 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045561
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
