Effects of Laser Therapy on Muscle Function in COPD Patients (LTCOPD)
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Purpose
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.
| Condition | Intervention |
|---|---|
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Chronic Obstructive Pulmonary Disease Fatigue |
Other: Laser therapy Other: Placebo laser therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effects of Light-emitting Diodes (LED) on Peripheral Muscle Function, Exercise Tolerance and Cardiorespiratory Response During Exercise in Patients With Chronic Obstructive Pulmonary Disease |
- 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. ] [ Designated as safety issue: Yes ]
- 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. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 27 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
The therapeutic effects of low intensity lasers are: (i) analgesic and anti-inflammatory, (ii) regeneration, (iii) tissue healing and (vi) recovery from muscle fatigue.
Other Name: (Light Emitting Diode)
|
| Placebo Comparator: Placebo Laser therapy |
Other: Placebo laser therapy
The application of laser therapy will be a low intensity laser.
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Eligibility| Ages Eligible for Study: | 40 Years to 90 Years |
| Genders Eligible for Study: | Both |
| 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:
- 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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Eduardo Foschini Miranda, Principal Investigator, University of Nove de Julho |
| ClinicalTrials.gov Identifier: | NCT01448564 History of Changes |
| Other Study ID Numbers: | COPD, COPD - LED |
| Study First Received: | October 3, 2011 |
| Last Updated: | July 30, 2012 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by University of Nove de Julho:
|
Chronic Obstructive Pulmonary Disease Fatigue laser therapy |
Additional relevant MeSH terms:
|
Fatigue Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Signs and Symptoms Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013