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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Nove de Julho
Sponsor:
Information provided by (Responsible Party):
Eduardo Foschini Miranda, University of Nove de Julho
ClinicalTrials.gov Identifier:
NCT01448564
First received: October 3, 2011
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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 Intervention
Chronic Obstructive Pulmonary Disease
Fatigue
Other: Laser therapy
Other: Placebo laser therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Nove de Julho:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 27
Study Start Date: June 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448564

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

No publications provided by University of Nove de Julho

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eduardo Foschini Miranda, Principal Investigator, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT01448564     History of Changes
Other Study ID Numbers: COPD, COPD - LED
Study First Received: October 3, 2011
Last Updated: September 3, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Nove de Julho:
Chronic Obstructive Pulmonary Disease
Fatigue
laser therapy

Additional relevant MeSH terms:
Fatigue
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014