Effects of Laser Therapy on Muscle Function in COPD Patients (LTCOPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease, Fatigue
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Laser therapy
Placebo laser therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, Fatigue, laser therapy
Eligibility Criteria
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.
Sites / Locations
- University Nove de JulhoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Laser therapy
Placebo Laser therapy
Arm Description
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.
Outcomes
Primary Outcome Measures
Analysis of the recovery time for the isometric and dynamic protocol
Secondary Outcome Measures
Analysis of lactate levels and the activity of CK and C-reactive protein (CRP).
Full Information
NCT ID
NCT01448564
First Posted
October 3, 2011
Last Updated
September 3, 2013
Sponsor
Eduardo Foschini Miranda
1. Study Identification
Unique Protocol Identification Number
NCT01448564
Brief Title
Effects of Laser Therapy on Muscle Function in COPD Patients
Acronym
LTCOPD
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2013 (undefined)
Study Completion Date
December 2013 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eduardo Foschini Miranda
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Fatigue
Keywords
Chronic Obstructive Pulmonary Disease, Fatigue, laser therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
27 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laser therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Laser therapy
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Laser therapy
Other Intervention Name(s)
(Light Emitting Diode)
Intervention Description
The therapeutic effects of low intensity lasers are: (i) analgesic and anti-inflammatory, (ii) regeneration, (iii) tissue healing and (vi) recovery from muscle fatigue.
Intervention Type
Other
Intervention Name(s)
Placebo laser therapy
Intervention Description
The application of laser therapy will be a low intensity laser.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo Miranda
Phone
05511 36659748
Email
foschinimedu@ig.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Simone Dal Corso
Phone
05511 36659748
Email
simonedc@uninove.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Miranda
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Nove de Julho
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo F Miranda, physiotherapist
Phone
05511 36659748
Email
foschinimedu@ig.com.br
First Name & Middle Initial & Last Name & Degree
Simone D Corso, physiotherapist
Phone
05511 36659758
Email
simonedc@uninove.br
First Name & Middle Initial & Last Name & Degree
Eduardo F Miranda, physiotherapist
12. IPD Sharing Statement
Citations:
PubMed Identifier
23663518
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Laser Therapy on Muscle Function in COPD Patients
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