Clinical trial NCT03639220: Photobiomodulation Therapy in Exercise Capacity Assessed by 6MST in Patients With COPD
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients with cardiac diseases
* Neuromuscular diseases
* Orthopedic disorders

Primary outcomes:
measure: The primary outcomes are oxygen uptake
timeFrame: 1 week
Secondary outcomes:
measure: The secondary outcomes are number of steps
timeFrame: 1 week
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Laboratory of Phototherapy in Sports and Exercise, Universidade Nove de Julho (UNINOVE)
state: SP
Study officials:
affiliation: Nove de Julho University
name: Eduardo Miranda, PhD
role: PRINCIPAL_INVESTIGATOR
References: