Chronic Obstructive Pulmonary DiseaseLTCOPDNCT01448564
Effects of Laser Therapy on Muscle Function in COPD Patients
A study testing Laser therapy in people with Chronic Obstructive Pulmonary Disease and Fatigue, run by Eduardo Foschini Miranda at 1 site in Brazil.
Trial summary
Light-emitting diodes (LEDs) have been used to minimize muscle fatigue in athletes and healthy subjects. Patients with chronic obstructive pulmonary disease (COPD) are susceptible to early muscle fatigue. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Fatigue
- What is being tested?
- Laser therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2012to Dec 2013
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 35 patients will be selected (see sample calculation in Section 6) who have moderate to severe obstruction (FEV1 ≤ 70% predicted) and stable disease, as suggested by the absence of changes in medication in the last 4 weeks.
Who cannot join
- Ischemic heart disease, recent surgery, neuro-muscular or orthopedic that limit the performance of the protocol.
- Patients will only be included in the study after signing the consent form.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University Nove de Julho
São Paulo, São Paulo
Eduardo F Miranda, physiotherapist, 05511 36659748, foschinimedu@ig.com.br
Simone D Corso, physiotherapist, 05511 36659758, simonedc@uninove.br
About this study
Official title: Effects of Light-emitting Diodes (LED) on Peripheral Muscle Function, Exercise Tolerance and Cardiorespiratory Response During Exercise in Patients With Chronic Obstructive Pulmonary Disease
Light-emitting diodes (LEDs) have been used to minimize muscle fatigue in athletes and healthy subjects. Patients with chronic obstructive pulmonary disease (COPD) are susceptible to early muscle fatigue. The objective of this study is to assess the acute effects of LEDs on muscle function, exercise capacity, and cardiorespiratory responses during isometric and dynamic exercise in patients with COPD. This study will assess 30 patients with moderate to severe obstruction (FEV1 ≤ 70% predicted). Isometric and dynamic protocols will be conducted in two visits each, for a total of four visits a week a part. First, a venous blood sample will be taken from the patients. The isometric protocol will start with the determination of the maximum voluntary isometric contraction (MIVC) to determine the workload (60% of MIVC) for the isometric endurance test (IET). Patients will be randomized to receive either the placebo or LED application. Immediately after finishing this procedure, the patients will carry out the IET until the limit of tolerance or until a 20% fall of strength is observed. After the test, another blood sample will be taken. In the other visit (one week later), the same order of procedures will be performed, except with the opposite (LED or placebo). For the dynamic protocol, the same procedures described above will be followed except with the maximal incremental cycle ergometer test used instead of the IET. The electromyography will be recorded during the isometric and dynamic protocols. Differences in muscle function, exercise capacity, and cardiorespiratory responses between the LED and placebo applications will be analyzed. The therapeutic effects of LED could minimize muscle fatigue in patients with COPD by increasing exercise tolerance.
- Conditions
- Chronic Obstructive Pulmonary Disease, Fatigue
- Being tested
- Laser therapy, Placebo laser therapy
- Keywords
- Chronic Obstructive Pulmonary Disease, Fatigue, laser therapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser therapyOther
Also called (Light Emitting Diode)
The therapeutic effects of low intensity lasers are: (i) analgesic and anti-inflammatory, (ii) regeneration, (iii) tissue healing and (vi) recovery from muscle fatigue.
Placebo laser therapyOther
The application of laser therapy will be a low intensity laser.
| Study group | Role | What they receive |
|---|---|---|
| Laser therapy | Active comparator | Recently has been using the LED, known by its acronym in English LED (Light Emitting Diode), devices that are light-emitting non-coherent and monochromatic, having a longer wavelength (± 10 - 30 nm) compared to lasers. The difference between the fundamental radiation emitted by a laser and an LED is the coherence of the beam. Receives: Other: Laser therapy |
| Placebo Laser therapy | Placebo comparator | Not described Receives: Other: Placebo laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the recovery time for the isometric and dynamic protocol
Measured: Measures muscular endurance will be compared after a period of 1 week.
Secondary outcomes (1)
Analysis of lactate levels and the activity of CK and C-reactive protein (CRP).
Measured: Measures blood will be compared after a period of 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startJun 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eduardo Foschini Miranda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eduardo Foschini Miranda, University of Nove de Julho
- Investigators
- Eduardo Miranda, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448564
- Sponsor's protocol ID
- COPD
- Other IDs
- COPD - LED
- Acronym
- LTCOPD
- Status last verified
- Sep 2013
- First submitted
- 3 Oct 2011
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Miranda EF, Leal-Junior EC, Marchetti PH, Dal Corso S. Effects of light-emitting diodes on muscle fatigue and exercise tolerance in patients with COPD: study protocol for a randomized controlled trial. Trials. 2013 May 10;14:134. doi: 10.1186/1745-6215-14-134.
PubMed 23663518
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Light-emitting Diodes (LED) on Peripheral Muscle Function, Exercise Tolerance and Cardiorespiratory Response During Exercise in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01448564
- Acronym / sponsor ID
- LTCOPD / COPD
- Conditions
- Chronic Obstructive Pulmonary Disease, Fatigue
- Keywords
- Chronic Obstructive Pulmonary Disease, Fatigue, laser therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Eduardo Foschini MirandaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2013
- Study completion
- Dec 2013
- First posted
- 7 Oct 2011 (estimated)
- 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.
Light-emitting diodes (LEDs) have been used to minimize muscle fatigue in athletes and healthy subjects. Patients with chronic obstructive pulmonary disease (COPD) are susceptible to early muscle fatigue. The objective of this study is to assess the acute effects of LEDs on muscle function, exercise capacity, and cardiorespiratory responses during isometric and dynamic exercise in patients with COPD. This study will assess 30 patients with moderate to severe obstruction (FEV1 ≤ 70% predicted). Isometric and dynamic protocols will be conducted in two visits each, for a total of four visits a week a part. First, a venous blood sample will be taken from the patients. The isometric protocol will start with the determination of the maximum voluntary isometric contraction (MIVC) to determine the workload (60% of MIVC) for the isometric endurance test (IET). Patients will be randomized to receive either the placebo or LED application. Immediately after finishing this procedure, the patients will carry out the IET until the limit of tolerance or until a 20% fall of strength is observed. After the test, another blood sample will be taken. In the other visit (one week later), the same order of procedures will be performed, except with the opposite (LED or placebo). For the dynamic protocol, the same procedures described above will be followed except with the maximal incremental cycle ergometer test used instead of the IET. The electromyography will be recorded during the isometric and dynamic protocols. Differences in muscle function, exercise capacity, and cardiorespiratory responses between the LED and placebo applications will be analyzed. The therapeutic effects of LED could minimize muscle fatigue in patients with COPD by increasing exercise tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser therapy | Active comparator | Other: Laser therapyRecently has been using the LED, known by its acronym in English LED (Light Emitting Diode), devices that are light-emitting non-coherent and monochromatic, having a longer wavelength (± 10 - 30 nm) compared to lasers. The difference between the fundamental radiation emitted by a laser and an LED is the coherence of the beam. |
| Placebo Laser therapy | Placebo comparator | Other: Placebo laser therapy |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 35 patients will be selected (see sample calculation in Section 6) who have moderate to severe obstruction (FEV1 ≤ 70% predicted) and stable disease, as suggested by the absence of changes in medication in the last 4 weeks.
Key exclusion criteria (2 listed)
- Ischemic heart disease, recent surgery, neuro-muscular or orthopedic that limit the performance of the protocol.
- Patients will only be included in the study after signing the consent form.
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 |
|---|---|---|
| Laser therapyAlso: (Light Emitting Diode)The therapeutic effects of low intensity lasers are: (i) analgesic and anti-inflammatory, (ii) regeneration, (iii) tissue healing and (vi) recovery from muscle fatigue. | Other | Laser therapy |
| Placebo laser therapyThe application of laser therapy will be a low intensity laser. | Other | Placebo Laser therapy |
Primary outcome
Analysis of the recovery time for the isometric and dynamic protocol
Time frame: Measures muscular endurance will be compared after a period of 1 week.
1 secondary outcome
Analysis of lactate levels and the activity of CK and C-reactive protein (CRP).
Time frame: Measures blood will be compared after a period of 1 week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
- Derived from this study: PubMed 23663518Miranda EF, Leal-Junior EC, Marchetti PH, Dal Corso S. Effects of light-emitting diodes on muscle fatigue and exercise tolerance in patients with COPD: study protocol for a randomized controlled trial. Trials. 2013 May 10;14:134. doi: 10.1186/1745-6215-14-134.
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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.
Eduardo Miranda principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser therapy in people with Chronic Obstructive Pulmonary Disease and Fatigue, run by Eduardo Foschini Miranda at 1 site in Brazil.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Sep 2013. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eduardo Miranda (05511 36659748, foschinimedu@ig.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the recovery time for the isometric and dynamic protocol (time frame: Measures muscular endurance will be compared after a period of 1 week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01448564, which also lists 1 linked publication.
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 4 Sep 2013.