Photobiomodulation Therapy in Exercise Capacity Assessed by 6MST in Patients With COPD

Overview

Chronic obstructive pulmonary disease (COPD) is characterized by dyspnea, as well as musculoskeletal and systemic manifestations. Photobiomodulation therapy (PBMT) with use of low-level laser therapy (LLLT) and/or light emitting diode therapy (LEDT) is an electrophysical intervention that has been found to minimize or delay muscle fatigue. The aim of this study is to evaluate the acute effect of PBMT with combined use of lasers diodes, light emitting diodes (LEDs), on muscle performance, exercise tolerance and metabolic variables during the 6-minute stepper test (6MST) in patients with COPD. Twenty-one patients with COPD will completed the 6MST protocol over 2 weeks, with 1 session per week. PBMT or placebo (PL) will be performed before each 6MST (17 sites on each lower limb, with a dose of 30 J per site, using a cluster of 12 diodes: 4 × 905 nm super-pulsed laser diodes, 4 × 875 nm infrared LEDs, and 4 × 640 nm red LEDs; Multi Radiance Medical™, Solon – OH, USA). Patients will be randomized into two groups before the test according to the treatment they will receive. Assessments will be performed before the start of each protocol. The primary outcomes are oxygen uptake and number of steps, and the secondary outcome are perceived exertion (dyspnea and fatigue in the lower limbs).

Full Title of Study: “Photobiomodulation Therapy Combining Laser Diodes, Light-emitting Diodes in Exercise Capacity Assessed by 6MST in Patients With COPD – A Crossover, Randomized, Triple-blinded, Placebo-controlled Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 14, 2018

Detailed Description

All patients will have a diagnosis of COPD according to the global initiative for chronic obstructive lung disease (GOLD) criteria. The patients will be at a stable phase of the disease, indicated by a lack of change in medical therapy (including oral steroids) or an exacerbation of symptoms in the preceding 4 weeks. Patients with other known severe chronic diseases, including cardiac, neuromuscular, or orthopedic disorders, will be excluded.

Interventions

  • Device: Photobiomodulation Therapy (PBMT)
    • Phototherapy device – Multi Radiance Medical™ (Solon, OH, EUA)

Arms, Groups and Cohorts

  • Active Comparator: Photobiomodulation Therapy (PBMT) active
    • Participants received active PBMT
  • Placebo Comparator: Photobiomodulation Therapy (PBMT) placebo
    • Participants received placebo PBMT

Clinical Trial Outcome Measures

Primary Measures

  • The primary outcomes are oxygen uptake
    • Time Frame: 1 week
    • The 6MST aims to measure the oxygen uptake performed on a stepper in 6 minutes. During the 6MST, the rates of oxygen consumption (VO2) will be measured using a gas analyzer.

Secondary Measures

  • The secondary outcomes are number of steps
    • Time Frame: 1 week
    • The 6MST aims to measure the number of steps performed on a stepper in 6 minutes. A step was defined as a single complete movement of raising one foot and putting it down. The stepper will be placed on the ground facing a wall to allow patients to maintain their balance by placing their fingers on the wall. The step height is set at 20 cm. The number of steps performed in 6 minutes will be recorded.

Participating in This Clinical Trial

Inclusion Criteria

  • COPD patients – Patients are at a stable phase of the disease Exclusion Criteria:

  • Patients with cardiac diseases – Neuromuscular diseases – Orthopedic disorders

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Nove de Julho
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ernesto Cesar Pinto Leal Junior, Full professor – University of Nove de Julho
  • Overall Official(s)
    • Eduardo Miranda, PhD, Principal Investigator, Nove de Julho University

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