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

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

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).

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD
• Intervention / Treatment: Device: Photobiomodulation Therapy (PBMT)

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 01504-001
      • Laboratory of Phototherapy in Sports and Exercise, Universidade Nove de Julho (UNINOVE)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• COPD patients
• Patients are at a stable phase of the disease

Exclusion Criteria:

• Patients with cardiac diseases
• Neuromuscular diseases
• Orthopedic disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Photobiomodulation Therapy (PBMT) active; Participants received active PBMT	Device: Photobiomodulation Therapy (PBMT); Phototherapy device - Multi Radiance Medical™ (Solon, OH, EUA)
Placebo Comparator: Photobiomodulation Therapy (PBMT) placebo; Participants received placebo PBMT	Device: Photobiomodulation Therapy (PBMT); Phototherapy device - Multi Radiance Medical™ (Solon, OH, EUA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcomes are oxygen uptake	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.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The secondary outcomes are number of steps	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.	1 week

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Investigators: Principal Investigator: Eduardo Miranda, PhD, Nove de Julho University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): August 14, 2018
• Study Completion (Actual): September 2, 2018

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 24, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: COPD_PBMT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes