Chronic Effects Using Light-Emitting Diode Therapy (LEDT) During a Resistance Exercise Protocol for Asthmatic Patients
1 other identifier
interventional
30
1 country
1
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 ..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 3, 2016
CompletedFirst Posted
Study publicly available on registry
April 13, 2017
CompletedApril 13, 2017
April 1, 2017
10 months
December 3, 2016
April 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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%).
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%).
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%).
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%).
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%).
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%).
Change from Baseline Peripheral muscular Strength up to 24 weeks.
Secondary Outcomes (2)
Functional Capacity by Cardiopulmonary exercise test.
Change from baseline measured by cardiopulmonary exercise test up to 24 weeks.
Functional Capacity by Incremental Shuytle Walk Test.
Change from baseline measured by Incremental Shuttle Walk Test distance up to 24 weeks.
Study Arms (2)
photobiomodulation by active LEDT
ACTIVE COMPARATORThe 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 COMPARATORThe 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.
Interventions
Light-emitting diode, has effects similar to the photobiomodulation by low-level laser intensity.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Nove de Julholead
- Fabiano Politticollaborator
- LUCIANA MARIA MALOSA SAMPAIOcollaborator
Study Sites (1)
Ivan Peres Costa
São Paulo, São Paulo, 05415-012, Brazil
Related Publications (2)
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.
PMID: 23743817BACKGROUNDDourado 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.
PMID: 19287905RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Luciana MM Sampaio, PhD
University of Nove de Julho
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physitherapist, Master and PhD student
Study Record Dates
First Submitted
December 3, 2016
First Posted
April 13, 2017
Study Start
March 1, 2014
Primary Completion
January 1, 2015
Study Completion
December 1, 2016
Last Updated
April 13, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share
IPD will not be shared with other researchers since there is no third party interest in the data collected.