Effects of Laser Therapy on Muscle Function in COPD Patients (LTCOPD)

• ClinicalTrials.gov Identifier: NCT01448564
• Recruitment Status: Unknown
• First Posted: October 7, 2011
• Last Update Posted: September 4, 2013
• Sponsor: Eduardo Foschini Miranda
• Information provided by (Responsible Party): Eduardo Foschini Miranda, University of Nove de Julho

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.

Condition or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease; Fatigue	Other: Laser therapy; Other: Placebo laser therapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: June 2012
• Primary Completion Date: December 2013
• Study Completion Date: December 2013

Arms and Interventions

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.	Other: Laser therapy; 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 Name: (Light Emitting Diode)
Placebo Comparator: Placebo Laser therapy	Other: Placebo laser therapy; The application of laser therapy will be a low intensity laser.

Outcome Measures

Primary Outcome Measures :

1. 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 Measures :

1. 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. ]

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Eduardo Miranda; 05511 36659748; foschinimedu@ig.com.br

Contact: Simone Dal Corso; 05511 36659748; simonedc@uninove.br

Locations

Brazil

University Nove de Julho; Recruiting

São Paulo, Brazil

Contact: Eduardo F Miranda, physiotherapist 05511 36659748 foschinimedu@ig.com.br

Contact: Simone D Corso, physiotherapist 05511 36659758 simonedc@uninove.br

Principal Investigator: Eduardo F Miranda, physiotherapist

Sponsors and Collaborators

Eduardo Foschini Miranda

Investigators

• Principal Investigator: Eduardo Miranda

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Eduardo Foschini Miranda, Principal Investigator, University of Nove de Julho
• ClinicalTrials.gov Identifier: NCT01448564
• Other Study ID Numbers: COPD; COPD - LED ( Other Identifier: COPD - LED )
• First Posted: October 7, 2011
• Last Update Posted: September 4, 2013
• Last Verified: September 2013

Keywords provided by Eduardo Foschini Miranda, University of Nove de Julho:

Chronic Obstructive Pulmonary Disease; Fatigue; laser therapy

Additional relevant MeSH terms:

Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Fatigue; Respiratory Tract Diseases