Clinical trial NCT01448564: Effects of Laser Therapy on Muscle Function in COPD Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Fatigue
Keywords: Chronic Obstructive Pulmonary Disease
Fatigue
laser therapy
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2011-10-07
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Analysis of the recovery time for the isometric and dynamic protocol
timeFrame: Measures muscular endurance will be compared after a period of 1 week.
Secondary outcomes:
measure: Analysis of lactate levels and the activity of CK and C-reactive protein (CRP).
timeFrame: Measures blood will be compared after a period of 1 week.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University Nove de Julho
Study officials:
name: Eduardo Miranda
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.