Trial Outcomes & Findings for Acupuncture to Enhance for Pulmonary Rehab (NCT NCT04947800)
NCT ID: NCT04947800
Last Updated: 2025-11-03
Results Overview
Change in Forced expiratory volume in one second (FEV1) as measures by spirometry test
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Results posted on
2025-11-03
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
0
|
0
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
1) Closure of pulm rehab program from which patients were recruited 2) recurrent IRB delays
|
8
|
0
|
0
|
Baseline Characteristics
Acupuncture to Enhance for Pulmonary Rehab
Baseline characteristics by cohort
| Measure |
Arm A: 12 week intervention, 8 week control
n=8 Participants
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
|
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
|
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
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
>=65 years
|
5 Participants
n=3 Participants
|
—
|
—
|
5 Participants
n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
—
|
—
|
3 Participants
n=4 Participants
|
|
Age, Continuous
|
67.9 years
n=3 Participants
|
—
|
—
|
67.9 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=3 Participants
|
—
|
—
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=3 Participants
|
—
|
—
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=3 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=3 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=3 Participants
|
—
|
—
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=3 Participants
|
—
|
—
|
8 participants
n=4 Participants
|
|
Pulmonary Function Test (FEV1)
|
1.38 Liters
n=3 Participants
|
—
|
—
|
1.38 Liters
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeksPopulation: Only baseline data was collected for Arm A. The study was closed before any data was collected for any other timepoints or Arms.
Change in Forced expiratory volume in one second (FEV1) as measures by spirometry test
Outcome measures
| Measure |
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
|
Arm A: 12 week intervention, 8 week control
n=8 Participants
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
|
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
|
|---|---|---|---|
|
Change in Forced Expiratory Volume in One Second (FEV1)
|
—
|
1.38 Liters
Interval 0.96 to 1.95
|
—
|
PRIMARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeksPopulation: The study was closed before any data was collected for any outcome measure aside from "Change in Forced expiratory volume in one second (FEV1)"
Change in Forced vital capacity (FVC) as measures by spirometry test
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeksPopulation: The study was closed before any data was collected for any outcome measure aside from "Change in Forced expiratory volume in one second (FEV1)"
Change in number of eosinophils as measured in blood samples
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeksPopulation: The study was closed before any data was collected for any outcome measure aside from "Change in Forced expiratory volume in one second (FEV1)"
Change in number of neutrophil as measured in blood samples
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeksPopulation: The study was closed before any data was collected for any outcome measure aside from "Change in Forced expiratory volume in one second (FEV1)"
Change in number of C reactive protein as measured in blood samples
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeksPopulation: The study was closed before any data was collected for any outcome measure aside from "Change in Forced expiratory volume in one second (FEV1)"
The Borg Dyspnea Scale scores range from 0 to 10, measuring subjective respiratory exertion with higher scores being worse
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeksPopulation: The study was closed before any data was collected for any outcome measure aside from "Change in Forced expiratory volume in one second (FEV1)"
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeksPopulation: The study was closed before any data was collected for any outcome measure aside from "Change in Forced expiratory volume in one second (FEV1)"
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeksPopulation: The study was closed before any data was collected for any outcome measure aside from "Change in Forced expiratory volume in one second (FEV1)"
Change in maximum distance walked in 6 minutes
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeksPopulation: The study was closed before any data was collected for any outcome measure aside from "Change in Forced expiratory volume in one second (FEV1)"
Throughout the course of the study acute exacerbations will be recorded and tallied.
Outcome measures
Outcome data not reported
Adverse Events
Arm A: 12 week intervention, 8 week control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm C: 4 week intervention, 16 week control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm B: 8 week intervention, 12 week control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place