Effects of the Low-level Laser Therapy on Functional Capacity of the Patients With Coronary Artery Bypass Surgery

NCT ID: NCT02688426

Last Updated: 2016-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-06-30

Brief Summary

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The low-level laser therapy (LLLT) has been used in many inflammatory disorders.

More recently the LLLT was associated with an improvement in the muscle strength, endurance and functional capacity.But, these effects were described only in health or athletic individuals. In this randomized and controlled clinical trails, the investigators will study the effects of LLLT on functional capacity of the patients with Coronary artery bypass surgery.

Detailed Description

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This study will be conducing in a large hospital that is reference in Coronary artery bypass surgery. 15 patients will be randomized for placebo or low-level laser therapy (LLLT). The functional capacity will be test by test six-minute walk test before and after de LLLT. Moreover the application of LBP or placebo will be followed by assessments of muscle damage and oxidative stress. One-week interval between the LLLT will gave to reduce the influence between the treatments.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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0J LLLT

The sham treatment is performed in the same way as treatment with LBP, however, with the apparatus switched off

Group Type SHAM_COMPARATOR

Sham Low-Level Laser Therapy (Sham LLLT)

Intervention Type DEVICE

perform with the machine off

6J Low-Level Laser Therapy (6J LLLT)

Intervention Type DEVICE

irradiation will be perform with 6J

6J LLLT

The Laser radiation will be made with 6J by spot.

Group Type EXPERIMENTAL

Sham Low-Level Laser Therapy (Sham LLLT)

Intervention Type DEVICE

perform with the machine off

6J Low-Level Laser Therapy (6J LLLT)

Intervention Type DEVICE

irradiation will be perform with 6J

Interventions

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Sham Low-Level Laser Therapy (Sham LLLT)

perform with the machine off

Intervention Type DEVICE

6J Low-Level Laser Therapy (6J LLLT)

irradiation will be perform with 6J

Intervention Type DEVICE

Other Intervention Names

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Sham LLLT 6J

Eligibility Criteria

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Inclusion Criteria

* Patients in the postoperative period of elective CABG referred for cardiac rehabilitation, which are the 15th and 30th days after surgery without ischemic changes and / or complex arrhythmias on the electrocardiogram, between 40 and 75 years of age who have performed the first surgery.

Exclusion Criteria

* Patients with decompensated heart failure; presence of any comorbidity such as: unstable angina; associated neurological disease; moderate respiratory illness to severe pre-diagnosed by the attending physician; active infectious disease or fever; disabling peripheral vascular disease; unstable ventricular arrhythmias; diabetes mellitus; use of cardiac pacemaker, musculoskeletal disease that limits physical activity, patients with a BMI ≥30.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Rodrigo Della Méa Plentz

Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rodrigo Della Méa Plentz

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Rodrigo Plentz, PhD

Role: CONTACT

+55 51 33038835

Facility Contacts

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Rodrigo Della Méa Plentz, PhD

Role: primary

+55 51 33038835

References

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Stein C, Fernandes RO, Miozzo AP, Coronel CC, Baroni BM, Bello-Klein A, Plentz RDM. Acute Effects of Low-Level Laser Therapy on Patients' Functional Capacity in the Postoperative Period of Coronary Artery Bypass Graft Surgery: A Randomized, Crossover, Placebo-Controlled Trial. Photomed Laser Surg. 2018 Mar;36(3):122-129. doi: 10.1089/pho.2017.4270. Epub 2018 Feb 21.

Reference Type DERIVED
PMID: 29466116 (View on PubMed)

Other Identifiers

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LLLT-CABG-2016/1

Identifier Type: -

Identifier Source: org_study_id

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