NCT03462537

Brief Summary

The purpose of the present study was to evaluate the effects of one session of aerobic exercise associated with low level laser therapy in lipolytic activity, lipid profile and inflammatory markers (C-reactive protein - CRP).

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Status
terminated

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

November 20, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
Last Updated

March 12, 2018

Status Verified

March 1, 2018

Enrollment Period

6 months

First QC Date

March 6, 2018

Last Update Submit

March 6, 2018

Conditions

Keywords

Aerobic ExerciseLipolytic LaserLipid ProfileC-reactive proteinLipolysis

Outcome Measures

Primary Outcomes (3)

  • Change in glycerol concentration

    Blood analysis collection was carried out with help from an clinical analysis technician.

    10 minutes before the intervention and 5 minutes after the intervention

  • Change in CRP concentration

    Blood analysis collection was carried out with help from an clinical analysis technician.

    10 minutes before the intervention and 5 minutes after the intervention

  • Change in lipid profile (LDL, HDL and triglyceride concentrations)

    Blood analysis collection was carried out with help from an clinical analysis technician.

    10 minutes before the intervention and 5 minutes after the intervention

Study Arms (3)

Experimental group 1

EXPERIMENTAL

This group performed aerobic exercise just after low level laser therapy in the abdominal region with eight electrodes distributed in line.

Device: Low level laser therapyDevice: Aerobic Exercise

Experimental group 2

EXPERIMENTAL

This group performed aerobic exercise just after low level laser therapy in the abdominal region with eight electrodes distributed in line, but low level laser therapy device was switched off.

Device: Aerobic ExerciseDevice: Low level laser therapy without power

Placebo group

PLACEBO COMPARATOR

Low level laser therapy without power. This group performed the low level laser therapy protocol, but low level laser therapy device was switched off.

Device: Low level laser therapy without power

Interventions

Low level laser therapy protocol - The low level laser therapy protocol was performed in dorsal decubitus, with the head elevated at 45º. The electrodes were placed in line, in the abdominal region. The low level laser therapy device has a length of about 940nm, using 8 pads, which have 64 diodes, each one with 100mW. The duration of the application was established in 8 minutes.

Experimental group 1

Aerobic exercise protocol - 50 minutes of aerobic moderate-intensity exercise (45-55% of reserve heart rate) using Karvonen´s formula, performed on a cycloergometer. The duration of the exercise was divided into three parts: warm-up (from 0 to 5 minutes); body (from 5 to 45 minutes); and cooling (from 45 to 50 minutes). The entire protocol was monitored through the Polar® brand cardiofrequency and watch.

Experimental group 1Experimental group 2

Low level laser therapy protocol - The low level laser therapy protocol was performed in dorsal decubitus, with the head elevated at 45º. The electrodes were placed in line, in the abdominal region. The low level laser therapy device has a length of about 940nm, using 8 pads, which have 64 diodes, each one with 100mW. The duration of the application was established in 8 minutes. In this group low level laser therapy device was switched off.

Experimental group 2Placebo group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18 and 25 years.
  • BMI between 18,5Kg/m2 and 29,9Kg/m2
  • consider presenting abdominal fat

You may not qualify if:

  • pregnant or intending to be in a period of 9 months
  • participants with smoking habits
  • participants with neoplasias, metabolic dysfunctions, renal pathologies, dermatological alterations
  • participants with electronic devices
  • participants with a condition that makes it impossible to practice physical exercise (disabling skeletal muscle pathologies and severe cardiorespiratory pathologies)
  • participants under the effect of beta-blockers or other drugs which influence heart rate
  • participants submitted to other fat reduce procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (28)

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    BACKGROUND
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    PMID: 25664493BACKGROUND
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    BACKGROUND
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MeSH Terms

Conditions

Metabolic Diseases

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 6, 2018

First Posted

March 12, 2018

Study Start

November 20, 2016

Primary Completion

May 20, 2017

Study Completion

June 20, 2017

Last Updated

March 12, 2018

Record last verified: 2018-03