Efficacy of Acupuncture in Exercise Tolerance in Patients With COPD

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Procedure: acupuncture

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Porto
    • Marco de Canaveses, Porto, Portugal, 4635 670
      • Carla Manuela Loureiro Barros

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Instituto de Ciências Biomédicas Abel Salazar
• Investigators: Study Chair: Henry Greten, Doctor, Abel Salazar Institute of Biomedical Sciences, University of Porto

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2018
• Primary Completion (Actual): September 25, 2018
• Study Completion (Actual): November 28, 2018

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): December 7, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: acupuncture

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No