NCT03112239

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

10 months

First QC Date

December 3, 2016

Last Update Submit

April 9, 2017

Conditions

Keywords

AsthmaPhotobiomodulationResistance Training

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 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.

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.

Device: Light-Emitting Diode Therapy (LEDT)

Interventions

Light-emitting diode, has effects similar to the photobiomodulation by low-level laser intensity.

Also known as: photobiomodulation by LEDT
photobiomodulation by Placebo LEDTphotobiomodulation by active LEDT

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Ivan Peres Costa

São Paulo, São Paulo, 05415-012, Brazil

Location

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: 23743817BACKGROUND
  • 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.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Luciana MM Sampaio, PhD

    University of Nove de Julho

    STUDY DIRECTOR

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.

Locations