Unique ID issued by UMIN | UMIN000008934 |
---|---|
Receipt number | R000009831 |
Scientific Title | Effect of long term intervention with acupuncture on COPD: A randomized controlled trial. |
Date of disclosure of the study information | 2012/10/01 |
Last modified on | 2023/02/08 15:07:46 |
Effect of long term intervention with acupuncture on COPD: A randomized controlled trial.
Long term intervention of acupuncture for COPD.
Effect of long term intervention with acupuncture on COPD: A randomized controlled trial.
Long term intervention of acupuncture for COPD.
Japan |
Chronic obstructive pulmonary disease: COPD
Pneumology | Adult |
Others
NO
To evaluate the improvement effect of QoL in stable COPD patients (GOLD classification II-IV) with acupuncture for 48 weeks treatments.
Safety,Efficacy
Confirmatory
Not applicable
QoL of COPD patients will be assessed before and after 52 weeks from baseline using the St George Respiratory Questionnaire (SGRQ total domain).
Secondary Endpoints
1. SGRQ (Total) will be assessed before and after 12 weeks from baseline.
2. SGRQ (Symptom, Activity, Impact) will be assessed before and after 12 and 52 weeks from baseline.
3. 6-minute walk test (dyspnea on exertion (modified Borg scale), walking distance, oxygen saturation (lowest), pulse rate (highest), and lower extremity fatigue (modified Borg scale)) will be assessed at 12 and 52 weeks from baseline.
Interventional
Parallel
Randomized
Individual
Single blind -investigator(s) and assessor(s) are blinded
Active
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Maneuver |
Patients in the acupuncture group (AG) receive acupuncture treatment once a week for 48 weeks, in addition to usual care.
*In accordance with the COPD guidelines developed by the World Health Organization (WHO), the National Heart, Lung, and Blood Institute (NHLBI), and the Japanese Respiratory Society, physicians provide usual care to all patients in AG groups.
Patients in the usual care group(UG) receive which is an outpatient visit once a month for 48 weeks.
*In accordance with the COPD guidelines developed by the World Health Organization (WHO), the National Heart, Lung, and Blood Institute (NHLBI), and the Japanese Respiratory Society, physicians provide usual care to all patients in UG groups.
40 | years-old | <= |
Not applicable |
Male and Female
1. Patient diagnosed as COPD and able to visit as outpatient.
2. Patient whose COPD condition is considered stable by his/her physician in charge.
3. Patient who has dyspnea on exertion due to COPD with Grade1 or higher by MMRC.
4. Patient in stage II or higher by GOLD guideline.
"Stable" here means when a COPD patient has no sudden deterioration in his/her symptoms of coughing, expectoration, or dyspnea on exertion during the 3 months period prior to the study outset, and is under a constant medication both in quantity and contents.
5. patients who had not been receiving pulmonary rehabilitation in the previous 6 months.
1. Patient who has heart disease (except for cor pulmonale), collagen disease (such as RA, PM/DM, etc.), cancer, severe mental disorders, or other severe complications.
2. Patient who is currently under pulmonary rehabilitation.
44
1st name | Motonari |
Middle name | |
Last name | Fukui |
Kitano hospital, the tazuke kofukai medical research institute
Division of Respiratory Medicine, Respiratory Disease Center
530-8480
2-4-20 Ougi-machi, Kitaku, Osaka, Japan
06-6312-1221
mfukui@kitano-hp.or.jp
1st name | Masao |
Middle name | |
Last name | SUZUKI |
Kitano hospital, the tazuke kofukai medical research institute
Division of Respiratory Medicine, Respiratory Disease Center
530-8480
2-4-20 Ougi-machi, Kitaku, Osaka, Japan
06-6312-1221
masuzuki@fmu.ac.jp
Division of respiratory Medicine respiratory disease center of kitano hospital the tazuke kofukai medical research institute
Japan Agency for MedicalResearch and Development.
Japanese Governmental office
JAPAN
National Hospital Organization Toneyama National Hospital.
The Japan society of acupuncture and moxibution.
Kitano hospital, the tazuke kofukai medical research institute
Kitano Hospital Medical Research Institute Ethics Committee
2-4-20 Ougi-machi, Kitaku, Osaka, Japan
06-6131-2911
rinshou@kitano-hp.or.jp
YES
1720
National Hospital Organization Osaka Toneyama Medical Center
田附興風会医学研究所北野病院呼吸器センター(大阪府)、医療法人池岡診療所(大阪府)、湊クリニック(大阪府)、独立行政法人国立病院機構(NHO)刀根山病院呼吸器内科(大阪府)
2012 | Year | 10 | Month | 01 | Day |
Unpublished
No longer recruiting
2012 | Year | 07 | Month | 17 | Day |
2012 | Year | 08 | Month | 17 | Day |
2013 | Year | 01 | Month | 15 | Day |
2019 | Year | 10 | Month | 31 | Day |
2020 | Year | 02 | Month | 14 | Day |
2020 | Year | 02 | Month | 29 | Day |
2020 | Year | 08 | Month | 30 | Day |
2012 | Year | 09 | Month | 17 | Day |
2023 | Year | 02 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009831
Research Plan | |
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Registered date | File name |
2019/12/30 | 英 LCAT 研究計画書.pdf |
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Research case data | |
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