Resistance TrainingNCT03112239
Chronic Effects Using Light-Emitting Diode Therapy (LEDT) During a Resistance Exercise Protocol for Asthmatic Patients
A study testing Light-Emitting Diode Therapy (LEDT) in people with Resistance Training, run by University of Nove de Julho at 1 site in Brazil.
Trial 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 .. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Resistance Training
- What is being tested?
- Light-Emitting Diode Therapy (LEDT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 ..
Read the 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.
- Conditions
- Resistance Training
- Being tested
- Light-Emitting Diode Therapy (LEDT)
- Keywords
- Asthma, Photobiomodulation, Resistance Training
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light-Emitting Diode Therapy (LEDT)Device
Also called photobiomodulation by LEDT
Light-emitting diode, has effects similar to the photobiomodulation by low-level laser intensity.
| Study group | Role | What they receive |
|---|---|---|
| photobiomodulation by active LEDT | Active comparator | 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. Receives: Device: Light-Emitting Diode Therapy (LEDT) |
| photobiomodulation by Placebo LEDT | Placebo comparator | 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. Receives: Device: Light-Emitting Diode Therapy (LEDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: Change from Baseline Peripheral muscular Strength up to 24 weeks.
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%).
Measured: Change from Baseline Peripheral muscular Strength up to 24 weeks.
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%).
Measured: Change from Baseline Peripheral muscular Strength up to 24 weeks.
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%).
Measured: Change from Baseline Peripheral muscular Strength up to 24 weeks.
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%).
Measured: Change from Baseline Peripheral muscular Strength up to 24 weeks.
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%).
Measured: Change from Baseline Peripheral muscular Strength up to 24 weeks.
Secondary outcomes (2)
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).
Measured: Change from baseline measured by cardiopulmonary exercise test up to 24 weeks.
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.
Measured: Change from baseline measured by Incremental Shuttle Walk Test distance up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study startMar 2014
- Primary completionJan 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Resistance TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Fabiano Politti, LUCIANA MARIA MALOSA SAMPAIO
- Responsible party
- Principal investigator, Ivan Peres Costa, University of Nove de Julho
- Investigators
- Luciana MM Sampaio, PhD, Study director, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112239
- Sponsor's protocol ID
- ERAMG-LED-PL-01
- Status last verified
- Apr 2017
- First submitted
- 3 Dec 2016
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: IPD will not be shared with other researchers since there is no third party interest in the data collected.
Publications
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.
PubMed 23743817Dourado 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.
PubMed 19287905
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03112239
- Acronym / sponsor ID
- ERAMG-LED-PL-01
- Conditions
- Resistance Training
- Keywords
- Asthma, Photobiomodulation, Resistance Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Fabiano Politti, LUCIANA MARIA MALOSA SAMPAIO
- Study start
- Mar 2014 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| photobiomodulation by active LEDT | Active comparator | Device: Light-Emitting Diode Therapy (LEDT)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. |
| photobiomodulation by Placebo LEDT | Placebo comparator | Device: Light-Emitting Diode Therapy (LEDT)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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light-Emitting Diode Therapy (LEDT)Also: photobiomodulation by LEDTLight-emitting diode, has effects similar to the photobiomodulation by low-level laser intensity. | Device | photobiomodulation by Placebo LEDT, photobiomodulation by active LEDT |
Primary outcome
Pectoral Muscular Strength by 1RM.
Time frame: Change from Baseline Peripheral muscular Strength up to 24 weeks.
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
Time frame: Change from Baseline Peripheral muscular Strength up to 24 weeks.
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
Time frame: Change from Baseline Peripheral muscular Strength up to 24 weeks.
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
Time frame: Change from Baseline Peripheral muscular Strength up to 24 weeks.
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
Time frame: Change from Baseline Peripheral muscular Strength up to 24 weeks.
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
Time frame: Change from Baseline Peripheral muscular Strength up to 24 weeks.
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%).
2 secondary outcomes
Functional Capacity by Cardiopulmonary exercise test.
Time frame: Change from baseline measured by cardiopulmonary exercise test up to 24 weeks.
Functional Capacity by Incremental Shuytle Walk Test.
Time frame: Change from baseline measured by Incremental Shuttle Walk Test distance up to 24 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Background: PubMed 23743817Miranda 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 publication: PubMed 19287905Dourado 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.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers since there is no third party interest in the data collected.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciana MM Sampaio, PhD study director
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light-Emitting Diode Therapy (LEDT) in people with Resistance Training, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pectoral Muscular Strength by 1RM. (time frame: Change from Baseline Peripheral muscular Strength up to 24 weeks.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03112239, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.