Resistance Training Clinical Trial
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.
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 ..
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.
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