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Efficacy of Acupuncture in Exercise Tolerance in Patients With COPD

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ClinicalTrials.gov Identifier: NCT03767140
Recruitment Status : Completed
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Carla Manuela Loureiro Barros, Instituto de Ciências Biomédicas Abel Salazar

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.


Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Procedure: acupuncture Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Efficacy of Acupuncture in Exercise Tolerance in Patients With COPD Controlled, Randomized, Double Blind Study
Actual Study Start Date : June 27, 2018
Actual Primary Completion Date : September 25, 2018
Actual Study Completion Date : November 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. six minute walk test (6MWT) [ Time Frame: 6 minutes ]
    distance walked (metres)


Secondary Outcome Measures :
  1. Oxygen peripheral saturation (SPO2) [ Time Frame: 6 minutes ]
    pulse oximeter

  2. Rating of perceived exertion (Borg Scale) [ Time Frame: 6 minutes ]
    during 6MWT

  3. Blood pressure [ Time Frame: 6 minutes ]
    measure at end of 6MWT

  4. heart rate [ Time Frame: 6 minutes ]
    at end of 6MWT



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 "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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767140


Locations
Portugal
Carla Manuela Loureiro Barros
Marco de Canaveses, Porto, Portugal, 4635 670
Sponsors and Collaborators
Instituto de Ciências Biomédicas Abel Salazar
Investigators
Study Chair: Henry Greten, Doctor Abel Salazar Institute of Biomedical Sciences, University of Porto

Responsible Party: Carla Manuela Loureiro Barros, Master student, Instituto de Ciências Biomédicas Abel Salazar
ClinicalTrials.gov Identifier: NCT03767140     History of Changes
Other Study ID Numbers: acupuncture
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive