Efficacy of Acupuncture in Exercise Tolerance in Patients With COPD

NCT03767140 | Completed DMC

• 1 other identifier: acupuncture
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• six minute walk test (6MWT)

  distance walked (metres)

  6 minutes

Secondary Outcomes (4)

• Oxygen peripheral saturation (SPO2)

  6 minutes

• Rating of perceived exertion (Borg Scale)

  6 minutes

• Blood pressure

  6 minutes

• heart rate

  6 minutes

Study Arms (2)

Verum acupucnture

EXPERIMENTAL

Real acupuncture treatment

Procedure: acupuncture

sham acupuncture

SHAM COMPARATOR

False acupuncture treatment using not acupuncture points

Procedure: acupuncture

Interventions

acupuncture PROCEDURE

The patients were randomized in two groups, one verum acupuncture, submitted to real acupuncture treatment, and the other sham acupuncture, treated with false acupuncture

Verum acupucnture; sham acupuncture

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Ciências Biomédicas Abel Salazar: lead

Study Sites (1)

Carla Manuela Loureiro Barros

Marco de Canaveses, Porto District, 4635 670, Portugal

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Henry Greten, Doctor

  Abel Salazar Institute of Biomedical Sciences, University of Porto

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master student

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 6, 2018
• Study Start: June 27, 2018
• Primary Completion: September 25, 2018
• Study Completion: November 28, 2018
• Last Updated: December 7, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)