Acupuncture to Enhance for Pulmonary Rehab
- Conditions
- COPD
- Interventions
- Device: Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36Device: Pulmonary rehabilitation program + Lv7/Gb26
- Registration Number
- NCT04947800
- Lead Sponsor
- Dartmouth-Hitchcock Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
- Patients must be 18 years of age or older
- Qualify to participate in the pulmonary rehab program at DHMC
- Severe cognitive impairment
- Active pulmonary exacerbation
- Unstable cardiopulmonary disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm C: 4 week intervention, 16 week control Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36 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. Arm A: 12 week intervention, 8 week control Pulmonary rehabilitation program + Lv7/Gb26 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 A: 12 week intervention, 8 week control Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36 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 Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36 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 B: 8 week intervention, 12 week control Pulmonary rehabilitation program + Lv7/Gb26 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 Pulmonary rehabilitation program + Lv7/Gb26 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.
- Primary Outcome Measures
Name Time Method Change in 6-minute walk distance Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks Change in maximum distance walked in 6 minutes
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
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.
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.
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 neutrophil Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks Change in number of neutrophil as measured in blood samples
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 number of eosinophils Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks Change in number of eosinophils 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States