UMIN-CTR Clinical Trial

Basic information
Public title	Acute effects of manual breathing assist technique on lung volume and recruitment of accessory inspiratory muscle, reducing dyspnea in patients with chronic obstructive pulmonary disease
Acronym	Effects of manual breathing assist technique in patients with chronic obstructive pulmonary disease
Scientific Title	Acute effects of manual breathing assist technique on lung volume and recruitment of accessory inspiratory muscle, reducing dyspnea in patients with chronic obstructive pulmonary disease
Scientific Title:Acronym	Acute effects of manual breathing assist technique on lung volume and recruitment of accessory inspiratory muscle, reducing dyspnea in patients with chronic obstructive pulmonary disease
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study was to investigate the effects of MBAT on reducing dyspnea, changing lung volumes and recruitment of sternocleidomastoid (SCM) muscle in severe COPD.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	lung volumes
Key secondary outcomes	muscle oxygenation dyspnea

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	a manual breathing assist technique
Interventions/Control_2	a manual breathing assist technique
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	65 years-old <=
Age-upper limit	95 years-old >=
Gender	Male and Female
Key inclusion criteria	COPD diagnosis by a respiratory physician, and no acute exacerbation for more than two months. Healthy people were screened during pre-participation to exclude those with pulmonary diagnosis and were further tested by spirometry to confirm absence of obstructive or restrictive impairments.
Key exclusion criteria	Exclusion criteria were: inability to lie in supine because of vertebral column or rib cage deformity or if they had osteoporosis with a history of compression and/or rib fractures.
Target sample size	28

Research contact person
Name of lead principal investigator	1st name Takako Middle name Last name Tanaka
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Physical Therapy Science
Zip code	852-8520
Address	1-7-1 Sakamotomachi, Nagasaki city, Nagasaki
TEL	+81958197919
Email	tanakataka@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Takako Middle name Last name Tanaka
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Physical Therapy Science
Zip code	852-8520
Address	1-7-1 Sakamotomachi, Nagasaki city, Nagasaki
TEL	+81958197919
Homepage URL
Email	tanakataka@nagasaki-u.ac.jp

Sponsor
Institute	Department of Physical Therapy Science, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization	Japan Society for Promotion of Science KAKENHI
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Department of Physical Therapy Science, Nagasaki University Graduate School of Biomedical Sciences
Address	1-7-1 Sakamotomachi, Nagasaki city, Nagasaki
Tel	+81958197919
Email	tanakataka@nagasaki-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	2021 Year 12 Month 23 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	28
Results	After respiratory assistance, tidal volume and preliminary inspiratory volume increased, and preliminary expiratory volume decreased.
Results date posted	2022 Year 06 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	chronic obstructive pulmonary disease: 14 elderly people: 14
Participant flow
Adverse events
Outcome measures	pulmonary function test dyspnea oxygenation
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 16 Day
Date of IRB	2017 Year 08 Month 22 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date	2022 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date	2021 Year 12 Month 23 Day
Last modified on	2022 Year 06 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052631