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

NCT ID: NCT03639220

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2018-09-02

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Photobiomodulation Therapy (PBMT) active

Participants received active PBMT

Group Type: ACTIVE_COMPARATOR

Photobiomodulation Therapy (PBMT)

Intervention Type: DEVICE

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

Photobiomodulation Therapy (PBMT) placebo

Participants received placebo PBMT

Group Type: PLACEBO_COMPARATOR

Photobiomodulation Therapy (PBMT)

Intervention Type: DEVICE

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

Interventions

Photobiomodulation Therapy (PBMT)

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Ernesto Cesar Pinto Leal Junior

Full professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eduardo Miranda, PhD

Role: PRINCIPAL_INVESTIGATOR

Nove de Julho University

Locations

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

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

COPD_PBMT

Identifier Type: -

Identifier Source: org_study_id