Efficacy of Acupuncture in Exercise Tolerance in Patients With COPD
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Inclusion Criteria:
- COPD GOLD III,IV;
- able to walk;
- Informed consent signed;
- stable medication during last 3 days
- exacerbation during 3 months;
- Chinese diagnose opening principle;
- blood pressure "90"180 mmhg/ "100mmhg; respiratory rate "10"30 cpm
Exclusion Criteria:
- smoker;
- metastasis;
- hepatic,
- renal or cardiovascular disease;
- pulmonary hypertension;
- COPD symptoms exacerbation during the therapy;
- previous acupuncture treatments;
- unstable vital signs;
- pulmonary rehabilitation in the last 6 months;
- needle phobia.
Sites / Locations
- Carla Manuela Loureiro Barros
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Verum acupucnture
sham acupuncture
Arm Description
Real acupuncture treatment
False acupuncture treatment using not acupuncture points
Outcomes
Primary Outcome Measures
six minute walk test (6MWT)
distance walked (metres)
Secondary Outcome Measures
Oxygen peripheral saturation (SPO2)
pulse oximeter
Rating of perceived exertion (Borg Scale)
during 6MWT
Blood pressure
measure at end of 6MWT
heart rate
at end of 6MWT
Full Information
NCT ID
NCT03767140
First Posted
December 5, 2018
Last Updated
December 5, 2018
Sponsor
Instituto de Ciências Biomédicas Abel Salazar
1. Study Identification
Unique Protocol Identification Number
NCT03767140
Brief Title
Efficacy of Acupuncture in Exercise Tolerance in Patients With COPD
Official Title
Efficacy of Acupuncture in Exercise Tolerance in Patients With COPD Controlled, Randomized, Double Blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
June 27, 2018 (Actual)
Primary Completion Date
September 25, 2018 (Actual)
Study Completion Date
November 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Ciências Biomédicas Abel Salazar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chronic Obstructive Pulmonary Disease (COPD) is nowadays the 4th cause of death in the world and it´s expected to become the 3rd cause of death in 2020 and the majority cause of morbidity. Besides that, in Portugal COPD patients become more dependents each day.
Acupuncture as a reflex therapy it´s carried out through a Traditional Chinese Medicine (TCM) diagnose that will allowed to identify the acupoints.
The investigators are interested in to assess acupuncture efficacy on physical exercise tolerance in COPD patients.An experimental, controlled, randomized, double blind study was done. Patients were recruited according TCM diagnose to optimize potential therapeutic effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients were randomized in two groups, one verum acupuncture, submitted to real acupuncture treatment, and the other sham acupuncture, treated with false acupuncture.
The method used to randomized was flipping a coin, when got heads they went to verum group and when got tails they went to sham group.
Masking
ParticipantInvestigator
Masking Description
Patients didn´t know what kind of therapy they were submitted The acupuncturist was a nurse, able to do invasive procedures with no knowledge of Chinese Medicine, and totally blind in terms of the verum or sham acupuncture.
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Verum acupucnture
Arm Type
Experimental
Arm Description
Real acupuncture treatment
Arm Title
sham acupuncture
Arm Type
Sham Comparator
Arm Description
False acupuncture treatment using not acupuncture points
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Intervention Description
The patients were randomized in two groups, one verum acupuncture, submitted to real acupuncture treatment, and the other sham acupuncture, treated with false acupuncture
Primary Outcome Measure Information:
Title
six minute walk test (6MWT)
Description
distance walked (metres)
Time Frame
6 minutes
Secondary Outcome Measure Information:
Title
Oxygen peripheral saturation (SPO2)
Description
pulse oximeter
Time Frame
6 minutes
Title
Rating of perceived exertion (Borg Scale)
Description
during 6MWT
Time Frame
6 minutes
Title
Blood pressure
Description
measure at end of 6MWT
Time Frame
6 minutes
Title
heart rate
Description
at end of 6MWT
Time Frame
6 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD GOLD III,IV;
able to walk;
Informed consent signed;
stable medication during last 3 days
exacerbation during 3 months;
Chinese diagnose opening principle;
blood pressure "90"180 mmhg/ "100mmhg; respiratory rate "10"30 cpm
Exclusion Criteria:
smoker;
metastasis;
hepatic,
renal or cardiovascular disease;
pulmonary hypertension;
COPD symptoms exacerbation during the therapy;
previous acupuncture treatments;
unstable vital signs;
pulmonary rehabilitation in the last 6 months;
needle phobia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Greten, Doctor
Organizational Affiliation
Abel Salazar Institute of Biomedical Sciences, University of Porto
Official's Role
Study Chair
Facility Information:
Facility Name
Carla Manuela Loureiro Barros
City
Marco de Canaveses
State/Province
Porto
ZIP/Postal Code
4635 670
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Acupuncture in Exercise Tolerance in Patients With COPD
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