UMIN-CTR Clinical Trial

Public title

Effect of the addition of exercise therapy to expiratory pressure load training in patients with chronic obstructive pulmonary disease: a multicenter, randomized controlled trial

Acronym

EPT-ET study

Scientific Title

Effect of the addition of exercise therapy to expiratory pressure load training in patients with chronic obstructive pulmonary disease: a multicenter, randomized controlled trial

Scientific Title:Acronym

EPT-ET study

Region

Japan

Condition

Chronic obstructive pulmonary disease

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effect of the addition of exercise therapy to expiratory pressure load training (EPT) in patients with chronic obstructive pulmonary disease (COPD). a multicenter, randomized controlled trial was conducted.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Endurance time, which will be evaluated by constant work rate exercise test during cardiopulmonary exercise testing (CPET)

Key secondary outcomes

i) Symptom (SGRQ score: Total domain, Symptom, Activity, Impact)
ii) Respiratory function (RV, RV/TLC)
iii) During CPET, which will consist of incremental exercise test or constant work rate exercise test the following parameters: oxygen uptake (VO2), minute ventilation (VE), ventilatory equivalent, physiologic dead space/ tidal volume ratio (VD/VT), expiratory tidal volume (VTex), mean expiratory flow (VTex/Te), inspiratory tidal volume (VTin), VTin- VTex, ratio of inspiratory time to total respiratory cycle time (Ti/Ttot), dyspnea (Borg scale), and oxygen extraction (the difference between inspired and expired O2 concentrations (delta FO2))
iv) Respiratory muscle pressure: maximum expiratory pressure (MEP)
v) 6-minute walk test: 6-minute walk distance, and Ti/Ttot
vi) Oxygen saturation of peripheral artery (SpO2) during the night
vii) Eating Assessment Tool (EAT-10)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

1) Patients who meet the eligibility criteria will be enrolled and randomly assigned in a 1:1 ratio into the EPT group or the EPT + exercise therapy group. In addition, patients of both groups will indicate the disease stage in equal population. In both groups, the patients will receive EPT 30 times twice daily for 6 months. The load of EPT 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 for the first 3 months. During the latter 3 months, the load will be maintained at 70% of the attained level at the first 3 months.

Interventions/Control_2

In the EPT + exercise therapy group, patients will receive exercise training using a cycle ergometer in 3 sets daily, 2 or 3 times a week during the latter 3 months. Initial exercise level was set at the work rate corresponding to 40% of the peak oxygen uptake obtained on the cardiopulmonary exercise testing (CPET) immediately before exercise training. After that, if possible, the training work rate will be extended to the work rate corresponding to 80% of the peak oxygen uptake obtained on the CPET immediately before exercise training.

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

40

years-old

<=

Age-upper limit

83

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Patients with moderate to very severe COPD (FEV1/FVC < 70%, and %FEV1< 80%, i.e., Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification airflow limitation severity, from II to IV)
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
(However, patients with no recurrence more than 5 years after treatment are not included in the exclusion criteria)
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 are receiving pulmonary rehabilitation
7) Patients who receive oxygen therapy during exercise
8) Patients with a history of pneumothorax or who have a giant bulla with a high risk of developing pneumothorax
9) In addition to the above exclusion criteria, patients judged by their physician to be ineligible to participate in this study

Target sample size

64

Name of lead principal investigator

1st name	Keisuke
Middle name
Last name	Miki

Organization

National Hospital Organization Osaka Toneyama Medical Center

Division name

Department of Respiratory Medicine

Zip code

560-8552

Address

5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan

TEL

+81668532001

Email

miki.keisuke.pu@mail.hosp.go.jp

Name of contact person

1st name	Keisuke
Middle name
Last name	Miki

Organization

National Hospital Organization Osaka Toneyama Medical Center

Division name

Department of Respiratory Medicine

Zip code

560-8552

Address

5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan

TEL

+81668532001

Homepage URL

Email

miki.keisuke.pu@mail.hosp.go.jp

Institute

National Hospital Organization Osaka Toneyama Medical Center

Institute

Department

Personal name

Organization

Grant from the Japan Society for the Promotion of Science, the Sugiura Memorial Foundation, and the Suzuken Memorial Foundation
Grant-in-Aid for Clinical Research from National Hospital Organization

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Kitano Hospital, Tazuke Kofukai Medical Research Institute
LIAA Tokushima Prefecture Naruto Hospital

Name of secondary funder(s)

Organization

National Hospital Organization Osaka Toneyama Medical Center

Address

5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan

Tel

+81668532001

Email

410-chiken@mail.hosp.go.jp

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

08

Month

06

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

Open public recruiting

Date of protocol fixation

2020

Year

06

Month

22

Day

Date of IRB

2020

Year

07

Month

27

Day

Anticipated trial start date

2020

Year

08

Month

14

Day

Last follow-up date

2026

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

07

Month

29

Day

Last modified on

2024

Year

03

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047110