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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Chronic Obstructive Pulmonary Disease (COPD

Intervention / Treatment
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* Device: Photobiomodulation Therapy (PBMT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD patients Patients are at a stable phase of the disease Exclusion Criteria: Patients with cardiac diseases Neuromuscular diseases Orthopedic disorders

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomization will be held by drawing lots, which we use to determine whether the active combination of superpulsed lasers, LEDs, comprising the PBMT or the placebo will be given during the first session. During the second session, participants will receive the opposite treatment compared to their first session. Randomization labels will be created using a randomization table at a central office where a series of sealed, opaque, and numbered envelopes ensured confidentiality.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |