CClinicalTrials.gg
Status unknownNCT01448564LTCOPDUpdated Sep 4, 2013

Effects of Laser Therapy on Muscle Function in COPD Patients

An interventional study of Laser therapy and Placebo laser therapy in Chronic Obstructive Pulmonary Disease and Fatigue, sponsored by Eduardo Foschini Miranda. Status unknown at 1 site in Brazil. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-09-04.

Sponsored by Eduardo Foschini Miranda · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
40 Years to 90 Years
Sex
All
01

Study summary

Light-emitting diodes (LEDs) have been used to minimize muscle fatigue in athletes and healthy subjects. Patients with chronic obstructive pulmonary disease (COPD) are susceptible to early muscle fatigue. The objective of this study is to assess the acute effects of LEDs on muscle function, exercise capacity, and cardiorespiratory responses during isometric and dynamic exercise in patients with COPD. This study will assess 30 patients with moderate to severe obstruction (FEV1 ≤ 70% predicted). Isometric and dynamic protocols will be conducted in two visits each, for a total of four visits a week a part. First, a venous blood sample will be taken from the patients. The isometric protocol will start with the determination of the maximum voluntary isometric contraction (MIVC) to determine the workload (60% of MIVC) for the isometric endurance test (IET). Patients will be randomized to receive either the placebo or LED application. Immediately after finishing this procedure, the patients will carry out the IET until the limit of tolerance or until a 20% fall of strength is observed. After the test, another blood sample will be taken. In the other visit (one week later), the same order of procedures will be performed, except with the opposite (LED or placebo). For the dynamic protocol, the same procedures described above will be followed except with the maximal incremental cycle ergometer test used instead of the IET. The electromyography will be recorded during the isometric and dynamic protocols. Differences in muscle function, exercise capacity, and cardiorespiratory responses between the LED and placebo applications will be analyzed. The therapeutic effects of LED could minimize muscle fatigue in patients with COPD by increasing exercise tolerance.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease
  • Fatigue

Keywords

  • Chronic Obstructive Pulmonary Disease
  • Fatigue
  • laser therapy
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 27 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

This is the only study on the registry with Eduardo Foschini Miranda as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 35 patients will be selected (see sample calculation in Section 6) who have moderate to severe obstruction (FEV1 ≤ 70% predicted) and stable disease, as suggested by the absence of changes in medication in the last 4 weeks.

Exclusion criteria

Exclusion Criteria:

  • Ischemic heart disease, recent surgery, neuro-muscular or orthopedic that limit the performance of the protocol.
  • Patients will only be included in the study after signing the consent form.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
27 participants (estimated)

Study arms

  • Active comparator
    Laser therapy

    Recently has been using the LED, known by its acronym in English LED (Light Emitting Diode), devices that are light-emitting non-coherent and monochromatic, having a longer wavelength (± 10 - 30 nm) compared to lasers. The difference between the fundamental radiation emitted by a laser and an LED is the coherence of the beam.

    Other: Laser therapy

  • Placebo comparator
    Placebo Laser therapy

    Other: Placebo laser therapy

Interventions

  • OtherLaser therapy

    The therapeutic effects of low intensity lasers are: (i) analgesic and anti-inflammatory, (ii) regeneration, (iii) tissue healing and (vi) recovery from muscle fatigue.

    Also known as: (Light Emitting Diode)

  • OtherPlacebo laser therapy

    The application of laser therapy will be a low intensity laser.

06

What researchers measure

Primary outcomes

  1. Analysis of the recovery time for the isometric and dynamic protocol

    Time frame: Measures muscular endurance will be compared after a period of 1 week.

Secondary outcomes

  1. Analysis of lactate levels and the activity of CK and C-reactive protein (CRP).

    Time frame: Measures blood will be compared after a period of 1 week.

07

Study locations

1 of 1 sites recruiting
  • University Nove de Julho
    São Paulo, Brazil
    • Eduardo F Miranda, physiotherapist · Contact · foschinimedu@ig.com.br · 05511 36659748
    • Simone D Corso, physiotherapist · Contact · simonedc@uninove.br · 05511 36659758
    • Eduardo F Miranda, physiotherapist · Principal investigator
    Recruiting
08

References and documents

Publications

  • Miranda EF, Leal-Junior EC, Marchetti PH, Dal Corso S. Effects of light-emitting diodes on muscle fatigue and exercise tolerance in patients with COPD: study protocol for a randomized controlled trial. Trials. 2013 May 10;14:134. doi: 10.1186/1745-6215-14-134. PubMed 23663518 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01448564
Lead sponsor
Eduardo Foschini Miranda
Responsible party
Eduardo Foschini Miranda (Principal Investigator, University of Nove de Julho) — Sponsor-investigator
First posted
Oct 7, 2011
Start date
Jun 2012
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Sep 4, 2013

Study contacts

Eduardo Miranda
Contact
foschinimedu@ig.com.br
05511 36659748
Simone Dal Corso
Contact
simonedc@uninove.br
05511 36659748
Eduardo Miranda
principal investigator

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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