Efficacy of Acupuncture in Exercise Tolerance in Patients With COPD

Study Overview
=================
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.

Official Title
-----------------
Efficacy of Acupuncture in Exercise Tolerance in Patients With COPD Controlled, Randomized, Double Blind Study

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Procedure: acupuncture


Participation Criteria
=================
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 90180 mmhg/ 100mmhg; respiratory rate 1030 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum acupucnture<br>Real acupuncture treatment | Procedure: acupuncture<br>* The patients were randomized in two groups, one verum acupuncture, submitted to real acupuncture treatment, and the other sham acupuncture, treated with false acupuncture<br>|
| Sham Comparator: sham acupuncture<br>False acupuncture treatment using not acupuncture points | Procedure: acupuncture<br>* The patients were randomized in two groups, one verum acupuncture, submitted to real acupuncture treatment, and the other sham acupuncture, treated with false acupuncture<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| six minute walk test (6MWT) | distance walked (metres) | 6 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen peripheral saturation (SPO2) | pulse oximeter | 6 minutes | 
| Rating of perceived exertion (Borg Scale) | during 6MWT | 6 minutes | 
| Blood pressure | measure at end of 6MWT | 6 minutes | 
| heart rate | at end of 6MWT | 6 minutes |