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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039568
Receipt No. R000045125
Scientific Title therapeutic effects of inspiratory muscle training on chronic obstructive pulmonary disease: systematic review and meta-analysis
Date of disclosure of the study information 2020/03/01
Last modified on 2020/02/22

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Basic information
Public title therapeutic effects of inspiratory muscle training on chronic obstructive pulmonary disease: systematic review and meta-analysis
Acronym therapeutic effects of inspiratory muscle training on chronic obstructive pulmonary disease: systematic review and meta-analysis
Scientific Title therapeutic effects of inspiratory muscle training on chronic obstructive pulmonary disease: systematic review and meta-analysis
Scientific Title:Acronym therapeutic effects of inspiratory muscle training on chronic obstructive pulmonary disease: systematic review and meta-analysis
Region
Japan

Condition
Condition chronic obstructive pulmonary disease
Classification by specialty
Pneumology Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this meta-analysis is to evaluate the effectiveness of inspiratory muscle training (IMT) and to investigate optimal condition of patients with on chronic obstructive pulmonary disease (COPD).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 6 min walk distance (6MWT),
Quality of life (St. George's Respiratory Questionnaire)
Key secondary outcomes Borg score,
Maximum inspiratory pressure (PImax)

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 Kenichi
Middle name
Last name Nishie
Organization Iida Municipal Hospital
Division name Department of Respiratory Medicine
Zip code 395-0851
Address 438, Yawatamachi, iida
TEL 0265211255
Email kennishie@imh.jp

Public contact
Name of contact person
1st name Kenichi
Middle name
Last name Nishie
Organization Iida Municipal Hospital
Division name Department of Respiratory Medicine
Zip code 395-0851
Address 438, Yawatamachi, iida
TEL 0265211255
Homepage URL
Email kennishie@imh.jp

Sponsor
Institute Iida Municipal Hospital
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 none
Address none
Tel none
Email none

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 01 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 02 Month 21 Day
Date of IRB
Anticipated trial start date
2020 Year 02 Month 22 Day
Last follow-up date
2020 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', 'inspiratory muscle trainning'. 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 IMT 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 IMT with sham or no treatment or no rehabilitation; (4) study reported on at least one of the outcome measures. The RCT that treatment are different between experimental arm and control arm except for IMT is excluded(ex, IMT with no rehabilitation vs only rehabilitation).

KN 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; IMT group (any device) and control group including Sham or no treatment or only pulmonary rehabilitation. Duration and intensity are not limited. Subgroups analyses are perform for the following comparisons: (1) year before 2006 versus after 2007; (2) Number of participants: under 19 versus from 21 to 99 versus over 100; (3) Severeity of COPD: GOLD I and II versus III and IV; (3) Device: threshold versus others; (4) Intensity: low-intensity (under 59% MIP) versus high-intensity IMT (over 60% MIP); (5) Duration: 1-4 weeks versus 5-12 weeks versus over 13 weeks; and (6) with or without any rehabilitation. In cases of substantial heterogeneity,analysis via meta-regression is performed to identify potential sources of bias.

Management information
Registered date
2020 Year 02 Month 22 Day
Last modified on
2020 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045125

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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