- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01448564
Effects of Laser Therapy on Muscle Function in COPD Patients (LTCOPD)
September 3, 2013 updated by: Eduardo Foschini Miranda
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eduardo Miranda
- Phone Number: 05511 36659748
- Email: foschinimedu@ig.com.br
Study Contact Backup
- Name: Simone Dal Corso
- Phone Number: 05511 36659748
- Email: simonedc@uninove.br
Study Locations
-
-
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São Paulo, Brazil
- Recruiting
- University Nove de Julho
-
Contact:
- Eduardo F Miranda, physiotherapist
- Phone Number: 05511 36659748
- Email: foschinimedu@ig.com.br
-
Contact:
- Simone D Corso, physiotherapist
- Phone Number: 05511 36659758
- Email: simonedc@uninove.br
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Principal Investigator:
- Eduardo F Miranda, physiotherapist
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Laser therapy
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.
|
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 Names:
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Placebo Comparator: Placebo Laser therapy
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The application of laser therapy will be a low intensity laser.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
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Measures muscular endurance will be compared after a period of 1 week.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
Measures blood will be compared after a period of 1 week.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eduardo Miranda
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Study Registration Dates
First Submitted
October 3, 2011
First Submitted That Met QC Criteria
October 6, 2011
First Posted (Estimate)
October 7, 2011
Study Record Updates
Last Update Posted (Estimate)
September 4, 2013
Last Update Submitted That Met QC Criteria
September 3, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COPD
- COPD - LED (Other Identifier: COPD - LED)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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