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
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
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
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
