UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and applicability of respiratory muscle training on the balance of inspiratory-to-expiratory muscle strength and breathing timing in patients with chronic obstructive pulmonary disease: a preparatory research study
Acronym	Efficacy of respiratory muscle training for breathing timing in chronic obstructive pulmonary disease
Scientific Title	Efficacy and applicability of respiratory muscle training on the balance of inspiratory-to-expiratory muscle strength and breathing timing in patients with chronic obstructive pulmonary disease: a preparatory research study
Scientific Title:Acronym	Efficacy of respiratory muscle training for breathing timing in chronic obstructive pulmonary disease
Region	Japan

Condition
Condition	Chronic obstructive pulmonary disease (COPD)
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this clinical trial, chronic obstructive pulmonary disease (COPD) patients will receive either three months of inspiratory or expiratory muscle training according to the pattern of resting/exertional breathing timing. In parallel with the training, nutrition treatment with medium-chain triglycerides (MCT) will also be given. The purpose of the present study was to determine the effect of training and treatment on the changes in balance between inspiratory and expiratory muscle strength and, subsequently, on the pattern of exertional breathing timing. We will also evaluate the benefits of these changes in exertional breathing timing, if any, on exercise tolerance in COPD patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Exertional changes in breathing timing (Ti/Ttot)
Key secondary outcomes	1.Symptom (CAT score, SGRQ score) 2.Body weight, Body Mass Index 3.Respiratory function (FEV1, %FEV1, FEV1%, VC, and %VC) 4.Forced oscillation technique (resistance and reactance) 5.The following parameters in cardiopulmonary exercise testing (CPET): minute ventilation (VE), oxygen uptake (VO2), carbon dioxide output (VCO2), breathing frequency (fR), tidal volume (VT), physiologic dead space/tidal volume ratio (VD/VT), dyspnea intensity (Borg scale), and exercise time 6.Respiratory muscle pressure (MIP), maximum inspiratory pressure (MIP), minimum expiratory pressure (MEP), |MIP|/MEP 7.Dual-energy X-ray absorptiometry (DEXA)

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food Other
Interventions/Control_1	1)All patients will be classified into two groups according to the change in Ti/Ttot during CPET. The patients in the Ti/Ttot increased group will receive inspiratory muscle training; the patients will receive inspiratory muscle training 30 times, twice per day for 3 months. The load of the respiratory training will be started at 20% of the maximum inspiratory pressure obtained at baseline and can be increased once every 2 weeks to up to 50% of the maximum pressure. 2)Administration of edible oil that comprises medium-chain C8 (octanoic acid) and C10 (decanoic acid) triglycerides. <The administration schedule of edible oil> 2.5 g of edible oil that comprises medium-chain C8 and C10 triglycerides will be administered orally, once daily, for 3 months.
Interventions/Control_2	1)All patients will be classified into two groups according to the change in Ti/Ttot during CPET. The patients in the Ti/Ttot decreased group will receive expiratory muscle training; the patients will receive expiratory muscle training 30 times, twice per day for 3 months. The load of the respiratory training will be started at 20% of the maximum expiratory pressure obtained at baseline and can be increased once every 2 weeks to up to 50% of the maximum pressure. 2)Administration of edible oil that comprises medium-chain C8 (octanoic acid) and C10 (decanoic acid) triglycerides. <The administration schedule of edible oil> 2.5 g of edible oil that comprises medium-chain C8 and C10 triglycerides will be administered orally, once daily, for 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	40 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Patients with moderate to very severe COPD (FEV1% < 70%, and %FEV1 < 80%, mMRC: grade 1and higher) 2)Patients whose conditions are stable and who are able to tolerate cardiopulmonary exercise testing to ensure adequate evaluation 3)Patients who have signed the agreement for participation in this study
Key exclusion criteria	1)Patients with malignant tumors 2)Patients with active infection 3)Patients with severe heart disease 4)Patients with asthma 5)Patients whose drug regimen was changed during this study 6)Patients who receive pulmonary rehabilitation 7)Patients who receive oxygen therapy at rest 8)Patients who are undergoing diabetes mellitus therapy or whose HbA1C is >7.0 9)In addition to the above exclusion criteria, patients judged by their physician to be inadequate to participate in this study
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Keisuke Miki
Organization	National Hospital Organization Toneyama National Hospital
Division name	Department of Respiratory Medicine
Zip code
Address	5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan.
TEL	06-6853-2001
Email	mikisuke@toneyama.go.jp

Public contact
Name of contact person	1st name Middle name Last name Keisuke Miki
Organization	National Hospital Organization Toneyama National Hospital
Division name	Department of Respiratory Medicine
Zip code
Address	5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan.
TEL	06-6853-2001
Homepage URL
Email	mikisuke@toneyama.go.jp

Sponsor
Institute	National Hospital Organization Toneyama National Hospital
Institute
Department

Funding Source
Organization	Grant-in-Aid for Clinical Research from National Hospital Organization
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2018 Year 02 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	Completed
Date of protocol fixation	2018 Year 01 Month 20 Day
Date of IRB	2018 Year 01 Month 19 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2020 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 22 Day
Last modified on	2022 Year 01 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035288