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

Sponsor

University of Nove de Julho (Other)

Overall Status

Completed

CT.gov ID

NCT03639220

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease (COPD	Device: Photobiomodulation Therapy (PBMT)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.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 (Participant, Investigator)

Masking Description:

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.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 1, 2017

Actual Primary Completion Date :

Aug 14, 2018

Actual Study Completion Date :

Sep 2, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Photobiomodulation Therapy (PBMT) active

Participants received active PBMT

Device: Photobiomodulation Therapy (PBMT)

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

Placebo Comparator: Photobiomodulation Therapy (PBMT) placebo

Participants received placebo PBMT

Device: Photobiomodulation Therapy (PBMT)

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

Outcome Measures

Primary Outcome Measures

The primary outcomes are oxygen uptake [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 Outcome Measures

The secondary outcomes are number of steps [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

COPD patients
Patients are at a stable phase of the disease

Exclusion Criteria:

Patients with cardiac diseases
Neuromuscular diseases
Orthopedic disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laboratory of Phototherapy in Sports and Exercise, Universidade Nove de Julho (UNINOVE)	São Paulo	SP	Brazil	01504-001

Sponsors and Collaborators

University of Nove de Julho

Investigators

Principal Investigator: Eduardo Miranda, PhD, Nove de Julho University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ernesto Cesar Pinto Leal Junior, Full professor, University of Nove de Julho

ClinicalTrials.gov Identifier:

NCT03639220

Other Study ID Numbers:

COPD_PBMT

First Posted:

Aug 21, 2018

Last Update Posted:

Apr 28, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Apr 28, 2020