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Effects of Laser Therapy on Muscle Function in COPD Patients

NCT ID: NCT01448564

Last Updated: 2013-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease Fatigue

Keywords

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Chronic Obstructive Pulmonary Disease Fatigue laser therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Laser therapy

Intervention Type OTHER

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

Placebo Laser therapy

Group Type PLACEBO_COMPARATOR

Placebo laser therapy

Intervention Type OTHER

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

Interventions

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Laser 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.

Intervention Type OTHER

Placebo laser therapy

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

Intervention Type OTHER

Other Intervention Names

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(Light Emitting Diode)

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eduardo Foschini Miranda

OTHER

Sponsor Role lead

Responsible Party

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Eduardo Foschini Miranda

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Eduardo Miranda

Role: PRINCIPAL_INVESTIGATOR

Locations

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University Nove de Julho

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Eduardo Miranda

Role: CONTACT

Phone: 05511 36659748

Email: [email protected]

Simone Dal Corso

Role: CONTACT

Phone: 05511 36659748

Email: [email protected]

Facility Contacts

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Eduardo F Miranda, physiotherapist

Role: primary

Simone D Corso, physiotherapist

Role: backup

References

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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.

Reference Type DERIVED
PMID: 23663518 (View on PubMed)

Other Identifiers

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COPD - LED

Identifier Type: OTHER

Identifier Source: secondary_id

COPD

Identifier Type: -

Identifier Source: org_study_id