UMIN-CTR Clinical Trial

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

chronic obstructive pulmonary disease

Classification by specialty

Pneumology	Rehabilitation medicine	Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

6 min walk distance (6MWT),
Quality of life (St. George's Respiratory Questionnaire)

Key secondary outcomes

Borg score,
Maximum inspiratory pressure (PImax)

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Iida Municipal Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

none

Address

none

Tel

none

Email

none

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

03

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2020

Year

02

Month

22

Day

Last modified on

2020

Year

02

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045125