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Chronic Effects Using Light-Emitting Diode Therapy (LEDT) During a Resistance Exercise Protocol for Asthmatic Patients

Primary Purpose

Resistance Training

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Light-Emitting Diode Therapy (LEDT)
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Resistance Training focused on measuring Asthma, Photobiomodulation, Resistance Training

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ivan Peres Costa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

photobiomodulation by active LEDT

photobiomodulation by Placebo LEDT

Arm Description

The subjects will be initially pre-evaluated by performing pulmonary function tests, peripheral muscle strength tests, 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 being associated to the intervention with active photobiomodulation by LEDT to increase peripheral muscle function post resistance training.

The subjects will be initially pre-evaluated by performing pulmonary function tests, peripheral muscle strength tests, 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 being associated to the intervention with placebo LEDT photobiomodulation to increase peripheral muscle function post resistance training.

Outcomes

Primary Outcome Measures

Pectoral Muscular Strength by 1RM.
Muscle strength will be assessed in the pectoral muscle group, using the maximal repetition (1RM) test to quantify the resistance training load (between 60 and 80%).
Major Dorsal Muscular Strength by 1RM
Muscle strength will be assessed in the major dorsal muscle group, using the maximal repetition (1RM) test to quantify the resistance training load (between 60 and 80%).
Femoral Quadriceps Muscular Strength by 1RM
Muscle strength will be assessed in the femoral quadriceps muscle group, using the maximal repetition (1RM) test to quantify the resistance training load (between 60 and 80%).
Brachial Triceps Muscular Strength by 1RM
Muscle strength will be assessed in the brachial triceps muscle group, using the maximal repetition (1RM) test to quantify the resistance training load (between 60 and 80%).
Brachial Biceps Muscular Strength by 1RM
Muscle strength will be assessed in the brachial biceps muscle group, using the maximal repetition (1RM) test to quantify the resistance training load (between 60 and 80%).
Tibial Ischia Muscular Strength by 1RM
Muscle strength will be assessed in the tibial ischia muscle group, using the maximal repetition (1RM) test to quantify the resistance training load (between 60 and 80%).

Secondary Outcome Measures

Functional Capacity by Cardiopulmonary exercise test.
The cardiopulmonary test will be performed in an electricomagnetic braking cycle ergometer connected to a system composed of gas analysis module attached to a module flow/wave analyzer and a microcomputer BreezeCardiO2 System. (medical Graphics Corporation - MGC, St. Paul, Mo, USA).
Functional Capacity by Incremental Shuytle Walk Test.
The incremental shuttle walk test was performed based on the original test description. The patient walk from side to side in a space of 10 meters identified by two cones inserted 0.5 from each end to avoid such sudden changes in speed. The participant was instructed to walk from cone to cone in one. A single point that the participant must keep pace and a triple beep indicates the beginning of a new level, the height at which the participant has increased the pace. The test comprised 12 levels, each lasting one minute. The speed of the first level was 1.8 Km/h, with an increase of 0.17 m/s every minute until reaching a top speed of 8.53 Km/h. The test was stopped when the participant was unable to reach the cone before the next beep.

Full Information

First Posted
December 3, 2016
Last Updated
April 9, 2017
Sponsor
University of Nove de Julho
Collaborators
Fabiano Politti, LUCIANA MARIA MALOSA SAMPAIO
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1. Study Identification

Unique Protocol Identification Number
NCT03112239
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
Collaborators
Fabiano Politti, LUCIANA MARIA MALOSA SAMPAIO

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resistance Training
Keywords
Asthma, Photobiomodulation, Resistance Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
photobiomodulation by active LEDT
Arm Type
Active Comparator
Arm Description
The subjects will be initially pre-evaluated by performing pulmonary function tests, peripheral muscle strength tests, 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 being associated to the intervention with active photobiomodulation by LEDT to increase peripheral muscle function post resistance training.
Arm Title
photobiomodulation by Placebo LEDT
Arm Type
Placebo Comparator
Arm Description
The subjects will be initially pre-evaluated by performing pulmonary function tests, peripheral muscle strength tests, 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 being associated to the intervention with placebo LEDT photobiomodulation to increase peripheral muscle function post resistance training.
Intervention Type
Device
Intervention Name(s)
Light-Emitting Diode Therapy (LEDT)
Other Intervention Name(s)
photobiomodulation by LEDT
Intervention Description
Light-emitting diode, has effects similar to the photobiomodulation by low-level laser intensity.
Primary Outcome Measure Information:
Title
Pectoral Muscular Strength by 1RM.
Description
Muscle strength will be assessed in the pectoral muscle group, using the maximal repetition (1RM) test to quantify the resistance training load (between 60 and 80%).
Time Frame
Change from Baseline Peripheral muscular Strength up to 24 weeks.
Title
Major Dorsal Muscular Strength by 1RM
Description
Muscle strength will be assessed in the major dorsal muscle group, using the maximal repetition (1RM) test to quantify the resistance training load (between 60 and 80%).
Time Frame
Change from Baseline Peripheral muscular Strength up to 24 weeks.
Title
Femoral Quadriceps Muscular Strength by 1RM
Description
Muscle strength will be assessed in the femoral quadriceps muscle group, using the maximal repetition (1RM) test to quantify the resistance training load (between 60 and 80%).
Time Frame
Change from Baseline Peripheral muscular Strength up to 24 weeks.
Title
Brachial Triceps Muscular Strength by 1RM
Description
Muscle strength will be assessed in the brachial triceps muscle group, using the maximal repetition (1RM) test to quantify the resistance training load (between 60 and 80%).
Time Frame
Change from Baseline Peripheral muscular Strength up to 24 weeks.
Title
Brachial Biceps Muscular Strength by 1RM
Description
Muscle strength will be assessed in the brachial biceps muscle group, using the maximal repetition (1RM) test to quantify the resistance training load (between 60 and 80%).
Time Frame
Change from Baseline Peripheral muscular Strength up to 24 weeks.
Title
Tibial Ischia Muscular Strength by 1RM
Description
Muscle strength will be assessed in the tibial ischia muscle group, using the maximal repetition (1RM) test to quantify the resistance training load (between 60 and 80%).
Time Frame
Change from Baseline Peripheral muscular Strength up to 24 weeks.
Secondary Outcome Measure Information:
Title
Functional Capacity by Cardiopulmonary exercise test.
Description
The cardiopulmonary test will be performed in an electricomagnetic braking cycle ergometer connected to a system composed of gas analysis module attached to a module flow/wave analyzer and a microcomputer BreezeCardiO2 System. (medical Graphics Corporation - MGC, St. Paul, Mo, USA).
Time Frame
Change from baseline measured by cardiopulmonary exercise test up to 24 weeks.
Title
Functional Capacity by Incremental Shuytle Walk Test.
Description
The incremental shuttle walk test was performed based on the original test description. The patient walk from side to side in a space of 10 meters identified by two cones inserted 0.5 from each end to avoid such sudden changes in speed. The participant was instructed to walk from cone to cone in one. A single point that the participant must keep pace and a triple beep indicates the beginning of a new level, the height at which the participant has increased the pace. The test comprised 12 levels, each lasting one minute. The speed of the first level was 1.8 Km/h, with an increase of 0.17 m/s every minute until reaching a top speed of 8.53 Km/h. The test was stopped when the participant was unable to reach the cone before the next beep.
Time Frame
Change from baseline measured by Incremental Shuttle Walk Test distance up to 24 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciana MM Sampaio, PhD
Organizational Affiliation
University of Nove de Julho
Official's Role
Study Director
Facility Information:
Facility Name
Ivan Peres Costa
City
São Paulo
ZIP/Postal Code
05415-012
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared with other researchers since there is no third party interest in the data collected.
Citations:
PubMed Identifier
23743817
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.
Results Reference
background
PubMed Identifier
19287905
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.
Results Reference
result

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Chronic Effects Using Light-Emitting Diode Therapy (LEDT) During a Resistance Exercise Protocol for Asthmatic Patients

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