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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03767140
Other study ID # acupuncture
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 27, 2018
Est. completion date November 28, 2018

Study information

Verified date December 2018
Source Instituto de Ciências Biomédicas Abel Salazar
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date November 28, 2018
Est. primary completion date September 25, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Portugal Carla Manuela Loureiro Barros Marco de Canaveses Porto

Sponsors (1)

Lead Sponsor Collaborator
Instituto de Ciências Biomédicas Abel Salazar

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary six minute walk test (6MWT) distance walked (metres) 6 minutes
Secondary Oxygen peripheral saturation (SPO2) pulse oximeter 6 minutes
Secondary Rating of perceived exertion (Borg Scale) during 6MWT 6 minutes
Secondary Blood pressure measure at end of 6MWT 6 minutes
Secondary heart rate at end of 6MWT 6 minutes
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