Pulmonary Disease, Chronic ObstructiveNCT03767140
Efficacy of Acupuncture in Exercise Tolerance in Patients With COPD
A study testing acupuncture in people with Pulmonary Disease, Chronic Obstructive, run by Instituto de Ciências Biomédicas Abel Salazar at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 sitePortugal
- Study dates
- 27 Jun 2018to 28 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- smoker;
- metastasis;
- hepatic,
- renal or cardiovascular disease;
- pulmonary hypertension;
- COPD symptoms exacerbation during the therapy;
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- previous acupuncture treatments;
- unstable vital signs;
- pulmonary rehabilitation in the last 6 months;
- needle phobia.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Carla Manuela Loureiro Barros
Marco de Canaveses, Porto District, 4635 670
About this study
Official title: 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- acupuncture
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
The patients were randomized in two groups, one verum acupuncture, submitted to real acupuncture treatment, and the other sham acupuncture, treated with false acupuncture
| Study group | Role | What they receive |
|---|---|---|
| Verum acupucnture | Experimental | Real acupuncture treatment Receives: Procedure: acupuncture |
| sham acupuncture | Sham comparator | False acupuncture treatment using not acupuncture points Receives: Procedure: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
six minute walk test (6MWT)
distance walked (metres)
Measured: 6 minutes
Secondary outcomes (4)
Oxygen peripheral saturation (SPO2)
pulse oximeter
Measured: 6 minutes
Rating of perceived exertion (Borg Scale)
during 6MWT
Measured: 6 minutes
Blood pressure
measure at end of 6MWT
Measured: 6 minutes
heart rate
at end of 6MWT
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start27 Jun 2018
- Primary completion25 Sep 2018
- Study completion28 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Ciências Biomédicas Abel Salazar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla Manuela Loureiro Barros, Instituto de Ciências Biomédicas Abel Salazar
- Investigators
- Henry Greten, Doctor, Study chair, Abel Salazar Institute of Biomedical Sciences, University of Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767140
- Sponsor's protocol ID
- acupuncture
- Status last verified
- Dec 2018
- First submitted
- 5 Dec 2018
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupuncture in Exercise Tolerance in Patients With COPD Controlled, Randomized, Double Blind Study
- ClinicalTrials.gov ID
- NCT03767140
- Acronym / sponsor ID
- acupuncture
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Instituto de Ciências Biomédicas Abel SalazarUniversity, hospital or other
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 25 Sep 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Verum acupucnture | Experimental | Procedure: acupunctureReal acupuncture treatment |
| sham acupuncture | Sham comparator | Procedure: acupunctureFalse acupuncture treatment using not acupuncture points |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- COPD GOLD III,IV;
- able to walk;
- Informed consent signed;
- stable medication during last 3 days
- exacerbation during 3 months;
Key exclusion criteria (10 listed)
- smoker;
- metastasis;
- hepatic,
- renal or cardiovascular disease;
- pulmonary hypertension;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureThe patients were randomized in two groups, one verum acupuncture, submitted to real acupuncture treatment, and the other sham acupuncture, treated with false acupuncture | Procedure or surgery | Verum acupucnture, sham acupuncture |
Primary outcome
six minute walk test (6MWT)
Time frame: 6 minutes
distance walked (metres)
4 secondary outcomes
Oxygen peripheral saturation (SPO2)
Time frame: 6 minutes
Rating of perceived exertion (Borg Scale)
Time frame: 6 minutes
Blood pressure
Time frame: 6 minutes
heart rate
Time frame: 6 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Greten, Doctor study chair
Abel Salazar Institute of Biomedical Sciences, University of Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Pulmonary Disease, Chronic Obstructive, run by Instituto de Ciências Biomédicas Abel Salazar at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
six minute walk test (6MWT) (time frame: 6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2018.