Effects of Laser Therapy on Muscle Function in COPD Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

— 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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01448564
• Other study ID #: COPD
• Secondary ID: COPD - LED
• Status: Unknown status
• Phase: N/A
• First received: October 3, 2011
• Last updated: September 3, 2013
• Start date: June 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2013
• Source: University of Nove de Julho
• Contact: Eduardo Miranda
• Phone: 05511 36659748
• Email: foschinimedu[@]ig.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 27
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Fatigue
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• Placebo laser therapy
The application of laser therapy will be a low intensity laser.

Locations

Country	Name	City	State
Brazil	University Nove de Julho	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Eduardo Foschini Miranda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of the recovery time for the isometric and dynamic protocol		Measures muscular endurance will be compared after a period of 1 week.
Secondary	Analysis of lactate levels and the activity of CK and C-reactive protein (CRP).		Measures blood will be compared after a period of 1 week.