UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039893
Receipt number R000045500
Scientific Title The effectiveness of inspiratory muscle training in patients with chronic obstructive pulmonary disease
Date of disclosure of the study information 2020/03/22
Last modified on 2020/03/22 23:26:57

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Basic information

Public title

The effectiveness of inspiratory muscle training in patients with chronic obstructive pulmonary disease

Acronym

The effectiveness of inspiratory muscle training in patients with chronic obstructive pulmonary disease

Scientific Title

The effectiveness of inspiratory muscle training in patients with chronic obstructive pulmonary disease

Scientific Title:Acronym

The effectiveness of inspiratory muscle training in patients with chronic obstructive pulmonary disease

Region

Japan


Condition

Condition

outpatients with chronic obstructive pulmonary disease

Classification by specialty

Pneumology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of inspiratory muscle training on exercise capacity and physical activity in patients with chronic obstructive pulmonary disease

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1) physical activity

Key secondary outcomes

1) 6-minutes walking test
2) maximum inspiratory mouth pressure (PImax)
3) COPD assessment test (CAT)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

YES

Dynamic allocation


Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

The pulmonary rehabilitation added inspiratory muscle training.
Inspiratory muscle training: 30-50% of PImax intensity, 30 breaths per session, 2 session per day, everyday during 3 months.

Interventions/Control_2

The pulmonary rehabilitation added inspiratory muscle training.
Inspiratory muscle training: less than 10% of PImax intensity, 30 breaths per session, 2 session per day, everyday during 3 months.

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


Not applicable

Gender

Male

Key inclusion criteria

1) The patients are in a stable condition with no exacerbation of COPD for at least the previous 3 months
2) The patients is able to operate the inspiratory muscle trainer and activity monitor
3) The patients is able to walk without assist and be independent in daily life
4) The patients do not experiment inspiratory muscle training at least the previous 1 year

Key exclusion criteria

the patients have no severe and/or unstable cardiac disease, orthopedic disease or mental disorder.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Takanobu
Middle name
Last name Shioya

Organization

Akita University Graduate School of Health Sciences

Division name

Department of Physical Therapy

Zip code

010-8543

Address

1-1-1, Hondo, Akita

TEL

018-884-1111

Email

shioya@hos.akita-u.ac.jp


Public contact

Name of contact person

1st name Kazuki
Middle name
Last name Okura

Organization

Akita University Hospital

Division name

Division of Rehabilitation

Zip code

010-8543

Address

44-2, Hasunuma, Aza, Hiroomote, Akita

TEL

0188846372

Homepage URL


Email

okura@hos.akita-u.ac.jp


Sponsor or person

Institute

Akita University Graduate School of Health Sciences

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

the medical ethics committee of Akita University School of Medicine

Address

1-1-1, Hondo, Akita

Tel

018-884-6028

Email

soken@hos.akita-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

市立秋田総合病院(秋田県)、海南病院(愛知県)、公立陶生病院(愛知県)、坂出市立病院(香川県)、江南病院(熊本県)、要町病院(東京都)、KKR高松病院(香川県)


Other administrative information

Date of disclosure of the study information

2020 Year 03 Month 22 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

59

Results

In primary outcome, a significant interaction was observed in the number of steps. In addition, there was a significant within-group difference only in the IMT group. In addition, MVPA also had a significant interaction. In addition, there was a significant within-group difference only in the IMT group.
In secondary outcome, PImax showed a significant interaction. In addition, there was a significant within-group difference only in the IMT group. There was no significant interaction with 6MWD and CAT.

Results date posted

2020 Year 03 Month 21 Day

Results Delayed

Delay expected

Results Delay Reason

Delayed analysis and article writing

Date of the first journal publication of results


Baseline Characteristics


Participant flow

Eligibility was assessed on 87 patients.
Consent was obtained from 59 patients during the recruitment period.
Four of them were excluded because even if the load on the inspiratory muscle trainer was minimized, the strength of the control group (less than 10% PImax) could not be satisfied.
55 patients were assigned to 27 in the intervention group and 28 in the control group.
In the intervention group, 3 patients dropped out due to acute exacerbation, acute orthopedic disease, and refusal to continue the intervention.
In the control group, one patient dropped out due to acute exacerbation.
Due to measurement deficiencies in one of the intervention groups, the analysis included 23 intervention groups and 27 control groups.

Adverse events

None

Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 08 Month 01 Day

Date of IRB

2016 Year 08 Month 29 Day

Anticipated trial start date

2016 Year 11 Month 01 Day

Last follow-up date

2018 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 03 Month 21 Day

Last modified on

2020 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045500


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name