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Efficacy of Acupuncture in Exercise Tolerance in Patients With COPD

NCT ID: NCT03767140

Last Updated: 2018-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-27

Study Completion Date

2018-11-28

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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Verum acupucnture

Real acupuncture treatment

Group Type EXPERIMENTAL

acupuncture

Intervention Type 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

sham acupuncture

False acupuncture treatment using not acupuncture points

Group Type SHAM_COMPARATOR

acupuncture

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Ciências Biomédicas Abel Salazar

OTHER

Sponsor Role lead

Responsible Party

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Carla Manuela Loureiro Barros

Master student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Henry Greten, Doctor

Role: STUDY_CHAIR

Abel Salazar Institute of Biomedical Sciences, University of Porto

Locations

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Carla Manuela Loureiro Barros

Marco de Canaveses, Porto District, Portugal

Site Status

Countries

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Portugal

Other Identifiers

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acupuncture

Identifier Type: -

Identifier Source: org_study_id