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1) Closure of pulm rehab program from which patients were recruited 2) recurrent IRB delays
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| Name | Class |
|---|---|
| American Academy of Medical Acupuncture | UNKNOWN |
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The investigator is investigating if acupuncture may improve pulmonary function, exercise tolerance, stress and modulate the inflammatory effects of chronic obstructive pulmonary disease (COPD). The investigator would like to measure the effect of the combination of acupuncture with standard pulmonary rehab in patients with COPD.
Participation in this study may last 3 months. The experimental intervention is electro-acupuncture. Electro-acupuncture is similar to Transcutaneous Electrical Nerve Stimulation (TENS) where a very small current of electricity is applied, in this case to specific acupuncture points. The intervention will be applied by a trained physician-acupuncturist. The treatment itself would be applied for 20 minutes prior to regularly scheduled pulmonary rehab session. All participants will receive electro-acupuncture for the duration of the study. Because the investigators are interested in the effect of dose, participants will be randomized to 4, 8 or 12 weeks of "active pulmonary" acupuncture versus "control" acupuncture. One third of the participants will be asked to undergo the intervention for 4 weeks, one third will be asked to undergo the intervention for 8 weeks and one third will be asked to undergo the intervention for 12 weeks. Intervention acupuncture needles will be placed on what are thought to be active points for helping lung function, control acupuncture needles will be placed in neutral locations. Participants will not be told which weeks they are receiving the active acupuncture versus the control. Information relating to pulmonary and physical function, standard blood markers of inflammation, and survey responses at the beginning, during and after the intervention will be collected. During the experimental period participants will be asked to fill out surveys on quality of life, pulmonary function and physical function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: 12 week intervention, 8 week control | Experimental | Electro acupuncture (EA) intervention will be administered for 12 weeks to the Lung Mu-Shu points and St36 which are related to lung function and general function. The EA control intervention will be administered for 8 weeks and will use Lv7 and Gb 26 which are near the other points but not traditionally related to lung function or general function. |
|
| Arm B: 8 week intervention, 12 week control | Experimental | Electro acupuncture (EA) intervention will be administered for 8 weeks to the Lung Mu-Shu points and St36 which are related to lung function and general function. The EA control intervention will be administered for 12 weeks and will use Lv7 and Gb 26 which are near the other points but not traditionally related to lung function or general function. |
|
| Arm C: 4 week intervention, 16 week control | Experimental | Electro acupuncture (EA) intervention will be administered for 4 weeks to the Lung Mu-Shu points and St36 which are related to lung function and general function. The EA control intervention will be administered for 16 weeks and will use Lv7 and Gb 26 which are near the other points but not traditionally related to lung function or general function. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36 | Device | Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Forced Expiratory Volume in One Second (FEV1) | Change in Forced expiratory volume in one second (FEV1) as measures by spirometry test | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks |
| Change in Forced Vital Capacity (FVC) | Change in Forced vital capacity (FVC) as measures by spirometry test | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks |
| Change in Number of Eosinophils | Change in number of eosinophils as measured in blood samples | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks |
| Change in Number of Neutrophil | Change in number of neutrophil as measured in blood samples | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks |
| Change in Number of C Reactive Protein | Change in number of C reactive protein as measured in blood samples | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks |
| Quality of Life Relating to Dyspnea as Measured by Borg Scales | The Borg Dyspnea Scale scores range from 0 to 10, measuring subjective respiratory exertion with higher scores being worse | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks |
| Change in Health Related Quality of Life as Measured by the St. George's Respiratory Questionnaire | The St. George's Respiratory Questionnaire scores range from 0 to 100, with higher scores indicating more limitations. The 50-item questionnaire was developed to measure health status (quality of life) in patients with diseases of airways obstruction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James E Stahl, MD, CM, MPH | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: 12 week intervention, 8 week control | Electro acupuncture (EA) intervention will be administered for 12 weeks to the Lung Mu-Shu points and St36 which are related to lung function and general function. The EA control intervention will be administered for 8 weeks and will use Lv7 and Gb 26 which are near the other points but not traditionally related to lung function or general function. Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36: Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points Pulmonary rehabilitation program + Lv7/Gb26: Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points |
| FG001 | Arm B: 8 week intervention, 12 week control | Electro acupuncture (EA) intervention will be administered for 8 weeks to the Lung Mu-Shu points and St36 which are related to lung function and general function. The EA control intervention will be administered for 12 weeks and will use Lv7 and Gb 26 which are near the other points but not traditionally related to lung function or general function. Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36: Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points Pulmonary rehabilitation program + Lv7/Gb26: Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points |
| FG002 | Arm C: 4 week intervention, 16 week control | Electro acupuncture (EA) intervention will be administered for 4 weeks to the Lung Mu-Shu points and St36 which are related to lung function and general function. The EA control intervention will be administered for 16 weeks and will use Lv7 and Gb 26 which are near the other points but not traditionally related to lung function or general function. Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36: Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points Pulmonary rehabilitation program + Lv7/Gb26: Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
1) Closure of pulm rehab program from which patients were recruited 2) recurrent IRB delays
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: 12 week intervention, 8 week control | Electro acupuncture (EA) intervention will be administered for 12 weeks to the Lung Mu-Shu points and St36 which are related to lung function and general function. The EA control intervention will be administered for 8 weeks and will use Lv7 and Gb 26 which are near the other points but not traditionally related to lung function or general function. Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36: Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points Pulmonary rehabilitation program + Lv7/Gb26: Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Forced Expiratory Volume in One Second (FEV1) | Change in Forced expiratory volume in one second (FEV1) as measures by spirometry test | Only baseline data was collected for Arm A. The study was closed before any data was collected for any other timepoints or Arms. | Posted | Mean | Full Range | Liters | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks |
|
1 year
The study was closed before any data was collected related to Adverse Events. All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: 12 week intervention, 8 week control | Electro acupuncture (EA) intervention will be administered for 12 weeks to the Lung Mu-Shu points and St36 which are related to lung function and general function. The EA control intervention will be administered for 8 weeks and will use Lv7 and Gb 26 which are near the other points but not traditionally related to lung function or general function. Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36: Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points Pulmonary rehabilitation program + Lv7/Gb26: Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points |
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Institutional challenges with IRB and and cutting pulmonary rehab program prevented this trial from being completed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| james stahl | Dartmouth-Hitchcock | 6036502000 | james.e.stahl@hitchcock.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2023 | Jul 22, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Participants will not be told which weeks they are receiving the active acupuncture versus the control.
| Pulmonary rehabilitation program + Lv7/Gb26 | Device | Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points |
|
| Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks |
| Change in Health Related Quality of Life as Measure by the Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire-9 scale questionnaire measures the level of depression. Score range is 0 to 27 points. Higher scores mean more severe depression. | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks |
| Change in 6-minute Walk Distance | Change in maximum distance walked in 6 minutes | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks |
| Incidence of Acute Exacerbations (AE) | Throughout the course of the study acute exacerbations will be recorded and tallied. | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks |
| BG001 | Arm B: 8 week intervention, 12 week control | Electro acupuncture (EA) intervention will be administered for 8 weeks to the Lung Mu-Shu points and St36 which are related to lung function and general function. The EA control intervention will be administered for 12 weeks and will use Lv7 and Gb 26 which are near the other points but not traditionally related to lung function or general function. Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36: Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points Pulmonary rehabilitation program + Lv7/Gb26: Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points |
| BG002 | Arm C: 4 week intervention, 16 week control | Electro acupuncture (EA) intervention will be administered for 4 weeks to the Lung Mu-Shu points and St36 which are related to lung function and general function. The EA control intervention will be administered for 16 weeks and will use Lv7 and Gb 26 which are near the other points but not traditionally related to lung function or general function. Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36: Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points Pulmonary rehabilitation program + Lv7/Gb26: Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pulmonary Function Test (FEV1) | Mean | Full Range | Liters |
|
| OG001 | Arm B: 8 week intervention, 12 week control | Electro acupuncture (EA) intervention will be administered for 8 weeks to the Lung Mu-Shu points and St36 which are related to lung function and general function. The EA control intervention will be administered for 12 weeks and will use Lv7 and Gb 26 which are near the other points but not traditionally related to lung function or general function. Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36: Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points Pulmonary rehabilitation program + Lv7/Gb26: Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points |
| OG002 | Arm C: 4 week intervention, 16 week control | Electro acupuncture (EA) intervention will be administered for 4 weeks to the Lung Mu-Shu points and St36 which are related to lung function and general function. The EA control intervention will be administered for 16 weeks and will use Lv7 and Gb 26 which are near the other points but not traditionally related to lung function or general function. Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36: Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points Pulmonary rehabilitation program + Lv7/Gb26: Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points |
|
|
| Primary | Change in Forced Vital Capacity (FVC) | Change in Forced vital capacity (FVC) as measures by spirometry test | The study was closed before any data was collected for any outcome measure aside from "Change in Forced expiratory volume in one second (FEV1)" | Posted | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks |
|
|
| Primary | Change in Number of Eosinophils | Change in number of eosinophils as measured in blood samples | The study was closed before any data was collected for any outcome measure aside from "Change in Forced expiratory volume in one second (FEV1)" | Posted | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks |
|
|
| Primary | Change in Number of Neutrophil | Change in number of neutrophil as measured in blood samples | The study was closed before any data was collected for any outcome measure aside from "Change in Forced expiratory volume in one second (FEV1)" | Posted | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks |
|
|
| Primary | Change in Number of C Reactive Protein | Change in number of C reactive protein as measured in blood samples | The study was closed before any data was collected for any outcome measure aside from "Change in Forced expiratory volume in one second (FEV1)" | Posted | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks |
|
|
| Primary | Quality of Life Relating to Dyspnea as Measured by Borg Scales | The Borg Dyspnea Scale scores range from 0 to 10, measuring subjective respiratory exertion with higher scores being worse | The study was closed before any data was collected for any outcome measure aside from "Change in Forced expiratory volume in one second (FEV1)" | Posted | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks |
|
|
| Primary | Change in Health Related Quality of Life as Measured by the St. George's Respiratory Questionnaire | The St. George's Respiratory Questionnaire scores range from 0 to 100, with higher scores indicating more limitations. The 50-item questionnaire was developed to measure health status (quality of life) in patients with diseases of airways obstruction. | The study was closed before any data was collected for any outcome measure aside from "Change in Forced expiratory volume in one second (FEV1)" | Posted | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks |
|
|
| Primary | Change in Health Related Quality of Life as Measure by the Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire-9 scale questionnaire measures the level of depression. Score range is 0 to 27 points. Higher scores mean more severe depression. | The study was closed before any data was collected for any outcome measure aside from "Change in Forced expiratory volume in one second (FEV1)" | Posted | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks |
|
|
| Primary | Change in 6-minute Walk Distance | Change in maximum distance walked in 6 minutes | The study was closed before any data was collected for any outcome measure aside from "Change in Forced expiratory volume in one second (FEV1)" | Posted | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks |
|
|
| Primary | Incidence of Acute Exacerbations (AE) | Throughout the course of the study acute exacerbations will be recorded and tallied. | The study was closed before any data was collected for any outcome measure aside from "Change in Forced expiratory volume in one second (FEV1)" | Posted | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Arm B: 8 week intervention, 12 week control | Electro acupuncture (EA) intervention will be administered for 8 weeks to the Lung Mu-Shu points and St36 which are related to lung function and general function. The EA control intervention will be administered for 12 weeks and will use Lv7 and Gb 26 which are near the other points but not traditionally related to lung function or general function. Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36: Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points Pulmonary rehabilitation program + Lv7/Gb26: Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Arm C: 4 week intervention, 16 week control | Electro acupuncture (EA) intervention will be administered for 4 weeks to the Lung Mu-Shu points and St36 which are related to lung function and general function. The EA control intervention will be administered for 16 weeks and will use Lv7 and Gb 26 which are near the other points but not traditionally related to lung function or general function. Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36: Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points Pulmonary rehabilitation program + Lv7/Gb26: Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points | 0 | 0 | 0 | 0 | 0 | 0 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |