Effects of Laser Therapy on Muscle Function in COPD Patients

NCT01448564 | Unknown DMC

• 2 other identifiers: COPDCOPD - LED
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease; Fatigue

Keywords

Chronic Obstructive Pulmonary Disease; Fatigue; laser therapy

Outcome Measures

Primary Outcomes (1)

• Analysis of the recovery time for the isometric and dynamic protocol

  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).

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

Study Arms (2)

Laser therapy

ACTIVE COMPARATOR

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 Laser therapy

PLACEBO COMPARATOR

Other: Placebo laser therapy

Interventions

Laser therapy 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.

Also known as: (Light Emitting Diode)

Laser therapy

Placebo laser therapy OTHER

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

Placebo Laser therapy

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eduardo Foschini Miranda: lead

Study Sites (1)

University Nove de Julho

São Paulo, São Paulo, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 23663518 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Fatigue

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Eduardo Miranda

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo Miranda

CONTACT

05511 36659748; foschinimedu@ig.com.br

Simone Dal Corso

CONTACT

05511 36659748; simonedc@uninove.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2011
• First Posted: October 7, 2011
• Study Start: June 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 4, 2013

Record last verified: 2013-09

Locations

BR (1)