UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical effect of adding acupuncture to pulmonary rehabilitation for patients with chronic obstructive pulmonary disease
Title of the study (Brief title)	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	Keisuke Miki
Organization	National Hospital Organization Toneyama National Hospital
Division name	Laboratory cheif, Division of clinical reserach, laboratory of respiratory science
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	Keisuke Miki
Organization	National Hospital Organization Toneyama National Hospital
Division name	Laboratory chief, Division of clinical reserach, laboratory of respiratory science
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, Division of clinical reserach,laboratory of respiratory science
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 02 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030951