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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026995
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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