UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026995
Receipt number R000030951
Scientific Title Clinical effect of adding acupuncture to pulmonary rehabilitation for patients with chronic obstructive pulmonary disease
Date of disclosure of the study information 2017/04/24
Last modified on 2017/04/30 16:28:56

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Basic information

Public title

Clinical effect of adding acupuncture to pulmonary rehabilitation for patients with chronic obstructive pulmonary disease

Acronym

Clinical trial of acupuncture-pulmonary rehabilitation combination in COPD patients

Scientific Title

Clinical effect of adding acupuncture to pulmonary rehabilitation for patients with chronic obstructive pulmonary disease

Scientific Title:Acronym

Clinical trial of acupuncture-pulmonary rehabilitation combination in COPD patients

Region

Japan


Condition

Condition

Chronic obstructive pulmonary disease (COPD)

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects and safety of acupuncture for three months followed by combined acupuncture-pulmonary rehabilitation (PR) for three months in patients with stable COPD who have moderate to very severe airway obstruction according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and grade 1 or more according to the Modified British Medical Research Council (mMRC).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

As outcomes of acupuncture monotherapy: endurance time, peak oxygen uptake (peak VO2).

Key secondary outcomes

1) As outcomes of acupuncture monotherapy: Borg scale, O2-pulse, VD/VT,VE/VO2, VE/VCO2, delta Fo2, all of which will be measured using cardiopulmonary exercise testing (CPET).

2) As outcomes of i) combined acupuncture-PR alone, and of ii) adding combined acupuncture-PR to acupuncture monotherapy (i.e., overall treatment), peak VO2, endurance time, Borg scale, O2-pulse, VD/VT, VE/VO2, VE/VCO2, delta FO2, all of which will be measured using CPET.

3) As outcomes of i) acupuncture monotherapy alone, ii) combined acupuncture-PR alone, and iii) adding combined acupuncture-PR to acupuncture monotherapy (i.e., overall treatment), a) respiratory muscle strength, b) body weight, c) CAT score, d) SGRQ, e) mMRC dyspnea scale, f) pulmonary function test (including MostGraph and expiratory fractional exhaled nitric oxide), g) daily physical activities measured using Activision markers, h) skeletal muscle mass, bone mass, and fat measured using dual-energy X-ray absorptiometry (DEXA), i) blood examination (norepinephrine, VEGF, ghrelin, hANP), and j) iliopsoas muscle (volume, CT number)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Acupuncture monotherapy (12 times in 3 months) followed by combined acupuncture-PR (adding 12 sessions of acupuncture therapy to 20 sessions of pulmonary rehabilitation in 3 months)

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



Eligibility

Age-lower limit

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)COPD determined according to diagnostic criteria and classified as stage II or more using the GOLD criteria. Those rated as grade 1 or more according to modified Medical Research Council dyspnea scale (mMRC) were included.
2)Age 40 or more years
3)Stable patients able to tolerate cardiopulmonary exercise testing to ensure adequate evaluation
4)Signed agreement to participate in the study

Key exclusion criteria

1)Malignant tumors
2)Active infectious disease
3)Severe heart disease
4)Hepatic failure (serum aspartate aminotransferase and alanine aminotransferase levels at least twice the upper limit of normal)
5)Renal failure (serum creatinine levels 2.0 mg/dL or more)
6)Bronchial asthma
7)Drug regimen changed during clinical trials
8)Participation in pulmonary rehabilitation programs
9)Judged inadequate to participate in the study by their physicians

Target sample size

14


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

Laboratory cheif, Division of clinical reserach, laboratory of respiratory science

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

Laboratory chief, Division of clinical reserach, laboratory of respiratory science

Zip code


Address

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

TEL

06-6853-2001

Homepage URL


Email

mikisuke@toneyama.go.jp


Sponsor or person

Institute

National Hospital Organization Toneyama National Hospital, Division of clinical reserach,laboratory of respiratory science

Institute

Department

Personal name



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

2017 Year 04 Month 24 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

Open public recruiting

Date of protocol fixation

2017 Year 02 Month 10 Day

Date of IRB


Anticipated trial start date

2017 Year 04 Month 24 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 04 Month 14 Day

Last modified on

2017 Year 04 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030951


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name