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

NCT03639220 | Completed FDA Device

• 1 other identifier: COPD_PBMT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Obstructive Pulmonary Disease (COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The secondary outcomes are number of steps

  1 week

Study Arms (2)

Photobiomodulation Therapy (PBMT) active

ACTIVE COMPARATOR

Participants received active PBMT

Device: Photobiomodulation Therapy (PBMT)

Photobiomodulation Therapy (PBMT) placebo

PLACEBO COMPARATOR

Participants received placebo PBMT

Device: Photobiomodulation Therapy (PBMT)

Interventions

Photobiomodulation Therapy (PBMT) DEVICE

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

Photobiomodulation Therapy (PBMT) active; Photobiomodulation Therapy (PBMT) placebo

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with cardiac diseases
• Neuromuscular diseases
• Orthopedic disorders

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

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

São Paulo, São Paulo, 01504-001, Brazil

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Eduardo Miranda, PhD

  Nove de Julho University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A participating researcher who programmed the PBMT device (Multi Radiance Medical™, Solon, OH) based on the randomization results performed the randomization. He will be instructed not to inform the participants or other researchers of the PBMT dose (active or placebo). Thus, the researcher who performed the PBMT will be blinded to the dose administered to the participants. To further maintain blinding, participants used opaque goggles to prevent them from seeing whether a light will be irradiated.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Model Details: 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.

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 21, 2018
• Study Start: August 1, 2017
• Primary Completion: August 14, 2018
• Study Completion: September 2, 2018
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)