COPD
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPulmonary 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
DEVICEPulmonary rehabilitation program + Lv7/Gb26
Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points
Sponsors
American Academy of Medical Acupuncture
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will not be told which weeks they are receiving the active acupuncture versus the control.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must be 18 years of age or older * Qualify to participate in the pulmonary rehab program at DHMC
Exclusion criteria
* Severe cognitive impairment * Active pulmonary exacerbation * Unstable cardiopulmonary disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Forced Expiratory Volume in One Second (FEV1) | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks | Change in Forced expiratory volume in one second (FEV1) as measures by spirometry test |
| Change in Forced Vital Capacity (FVC) | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks | Change in Forced vital capacity (FVC) as measures by spirometry test |
| Change in Number of Eosinophils | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks | Change in number of eosinophils as measured in blood samples |
| Change in Number of Neutrophil | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks | Change in number of neutrophil as measured in blood samples |
| Change in Number of C Reactive Protein | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks | Change in number of C reactive protein as measured in blood samples |
| Quality of Life Relating to Dyspnea as Measured by Borg Scales | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks | The Borg Dyspnea Scale scores range from 0 to 10, measuring subjective respiratory exertion with higher scores being worse |
| Change in Health Related Quality of Life as Measured by the St. George's Respiratory Questionnaire | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks | 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. |
| Change in Health Related Quality of Life as Measure by the Patient Health Questionnaire (PHQ-9) | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks | 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. |
| Change in 6-minute Walk Distance | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks | Change in maximum distance walked in 6 minutes |
| Incidence of Acute Exacerbations (AE) | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks | Throughout the course of the study acute exacerbations will be recorded and tallied. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| 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 |
| 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 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | 1) Closure of pulm rehab program from which patients were recruited 2) recurrent IRB delays | 8 | 0 | 0 |
Baseline characteristics
| Characteristic | Arm A: 12 week intervention, 8 week control | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants |
| Age, Continuous | 67.9 years | 67.9 years |
| Pulmonary Function Test (FEV1) | 1.38 Liters | 1.38 Liters |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 8 Participants |
| Region of Enrollment United States | 8 participants | 8 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in 6-minute Walk Distance
Change in maximum distance walked in 6 minutes
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Population: The study was closed before any data was collected for any outcome measure aside from Change in Forced expiratory volume in one second (FEV1)
Primary
Change in Forced Expiratory Volume in One Second (FEV1)
Change in Forced expiratory volume in one second (FEV1) as measures by spirometry test
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Population: Only baseline data was collected for Arm A. The study was closed before any data was collected for any other timepoints or Arms.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm A: 12 week intervention, 8 week control | Change in Forced Expiratory Volume in One Second (FEV1) | 1.38 Liters |
Primary
Change in Forced Vital Capacity (FVC)
Change in Forced vital capacity (FVC) as measures by spirometry test
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Population: The study was closed before any data was collected for any outcome measure aside from Change in Forced expiratory volume in one second (FEV1)
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.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Population: The study was closed before any data was collected for any outcome measure aside from Change in Forced expiratory volume in one second (FEV1)
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.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Population: The study was closed before any data was collected for any outcome measure aside from Change in Forced expiratory volume in one second (FEV1)
Primary
Change in Number of C Reactive Protein
Change in number of C reactive protein as measured in blood samples
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Population: The study was closed before any data was collected for any outcome measure aside from Change in Forced expiratory volume in one second (FEV1)
Primary
Change in Number of Eosinophils
Change in number of eosinophils as measured in blood samples
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Population: The study was closed before any data was collected for any outcome measure aside from Change in Forced expiratory volume in one second (FEV1)
Primary
Change in Number of Neutrophil
Change in number of neutrophil as measured in blood samples
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Population: The study was closed before any data was collected for any outcome measure aside from Change in Forced expiratory volume in one second (FEV1)
Primary
Incidence of Acute Exacerbations (AE)
Throughout the course of the study acute exacerbations will be recorded and tallied.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Population: The study was closed before any data was collected for any outcome measure aside from Change in Forced expiratory volume in one second (FEV1)
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
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Population: The study was closed before any data was collected for any outcome measure aside from Change in Forced expiratory volume in one second (FEV1)