Clinical trial NCT03112239: Chronic Effects Using Light-Emitting Diode Therapy (LEDT) During a Resistance Exercise Protocol for Asthmatic Patients
Official title: Chronic Effects Using Light-Emitting Diode Therapy (LEDT) During a Resistance Exercise Protocol for Moderate to Severe Asthmatic Patients: a Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resistance Training
Keywords: Asthma
Photobiomodulation
Resistance Training
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: Fabiano Politti
name: LUCIANA MARIA MALOSA SAMPAIO
First posted: 2017-04-13
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the effects of LED phototherapy associated with a resistance training protocol on the peripheral muscle function of moderate to severe asthmatic patients ..

Detailed description: This research project will be prospective, analytical and of the randomized controlled clinical trial type, with blind evaluator. The sample type will be consecutive from Santa Casa de Misericórdia de São Paulo. We will study 30 adults of both sexes with moderate to severe asthma between the ages of 20 and 70, based on the sample calculation of the outcomes of this study.

Adult individuals 20 years of age or older with a diagnosis of moderate to severe asthma of both sexes, attended at the Ambulatory of Difficult Asthma Control of Santa Casa de Misericórdia de São Paulo.

Exclusion terms include subjects diagnosed as having heart disease associated with pulmonary disease, musculoskeletal pathology that may interfere with assessment or exercise, pulmonary hypertension, calcium absorption deficiency, BMI ≥ 30 or difficulty learning.

The subjects will initially be pre-evaluated by performing pulmonary function tests, peripheral muscle strength (1-RM), functional capacity tests, physical activity questionnaires and clinical control of asthma and cardiopulmonary exercise test. After the evaluation, patients will be randomized into two resistance training groups, one of them associated with active LED phototherapy and another LED phototherapy placebo.

The resistance exercise protocol will be performed on the muscles: Pectoral, Large Dorsal, Brachial Biceps, Brachial Triceps, Quadriceps and Tibial Ischia. The intensity will be from 40 to 70% obtained in the 1-RM test with two to three sets of ten repetitions.

The load increase will be performed weekly (5%) according to patient tolerance. After 12 weeks all subjects were reevaluated and the last reevaluation occurred at the end of the training program. Patients will only effectively begin participating in this study after explaining the terms of the survey and by accepting written consent from the ICF.

The mean (in kg) of the resistance training protocol for lower limbs in knee extension of group 1 was 33 ± 13 kg and the mean of group 2 was 46 ± 11 kg. The sample calculation was based on the load of the quadriceps muscle, α = 0.05 and β = 95%, determining a minimum of fourteen individuals for each group. An additional 10% was added to compensate for possible losses during the protocol. Thus a minimum of fifteen individuals will be required for the study.

Linear regression models will be used to evaluate the effect of the LED on the results (absolute change and percentage) and a sensitivity analysis with the values of the results in the revaluation, adjusted by the initial value of each result. The possible correlations between the variables can be evaluated using Pearson's correlation. The level of significance adopted will be p \<0.5. The analyzes were performed with SPSS 20 software.

Eligibility criteria: Inclusion Criteria:

* Patients with a medical outpatient setting less than six months; With a stable clinical picture during three months, ie without exacerbations and with optimized drug therapy.

Signed an informed consent form (TCLE) accepting participation in the research.

Exclusion Criteria:

* Diagnosis of heart disease associated with lung disease, musculoskeletal disease that may interfere with assessment or exercise, pulmonary hypertension, calcium absorption deficiency, BMI ≥ 30, or difficulty learning.

Primary outcomes:
measure: Pectoral Muscular Strength by 1RM.
timeFrame: Change from Baseline Peripheral muscular Strength up to 24 weeks.
measure: Major Dorsal Muscular Strength by 1RM
timeFrame: Change from Baseline Peripheral muscular Strength up to 24 weeks.
measure: Femoral Quadriceps Muscular Strength by 1RM
timeFrame: Change from Baseline Peripheral muscular Strength up to 24 weeks.
measure: Brachial Triceps Muscular Strength by 1RM
timeFrame: Change from Baseline Peripheral muscular Strength up to 24 weeks.
measure: Brachial Biceps Muscular Strength by 1RM
timeFrame: Change from Baseline Peripheral muscular Strength up to 24 weeks.
measure: Tibial Ischia Muscular Strength by 1RM
timeFrame: Change from Baseline Peripheral muscular Strength up to 24 weeks.
Secondary outcomes:
measure: Functional Capacity by Cardiopulmonary exercise test.
timeFrame: Change from baseline measured by cardiopulmonary exercise test up to 24 weeks.
measure: Functional Capacity by Incremental Shuytle Walk Test.
timeFrame: Change from baseline measured by Incremental Shuttle Walk Test distance up to 24 weeks.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Ivan Peres Costa
Study officials:
affiliation: University of Nove de Julho
name: Luciana MM Sampaio, PhD
role: STUDY_DIRECTOR
References:
citation: Miranda EF, Leal-Junior EC, Marchetti PH, Dal Corso S. Acute effects of light emitting diodes therapy (LEDT) in muscle function during isometric exercise in patients with chronic obstructive pulmonary disease: preliminary results of a randomized controlled trial. Lasers Med Sci. 2014 Jan;29(1):359-65. doi: 10.1007/s10103-013-1359-5. Epub 2013 Jun 7.
citation: Dourado VZ, Tanni SE, Antunes LC, Paiva SA, Campana AO, Renno AC, Godoy I. Effect of three exercise programs on patients with chronic obstructive pulmonary disease. Braz J Med Biol Res. 2009 Mar;42(3):263-71. doi: 10.1590/s0100-879x2009000300007.