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OpenTrials
Completed

NCT Number: NCT03639220

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

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).

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of Phototherapy in Sports and Exercise, Universidade Nove de Julho (UNINOVE)

São Paulo, 01504-001, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with cardiac diseases
  • Neuromuscular diseases
  • Orthopedic disorders

Treatment and study plan

Photobiomodulation therapy (PBMT)

Device

Phototherapy device - Multi Radiance Medical™ (Solon, OH, EUA)

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 21, 2018
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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