Acute Effect of Phototherapy With Light Emitting Diode (LED) on Muscle and Pulmonary Oxygen Consumption on Diabetes Mellitus

A

Aparecida Maria Catai

Status

Unknown

Conditions

Type 2 Diabetes Mellitus

Treatments

Device: Placebo phototherapy - 150J
Device: Phototherapy through light emitting diode (LED) - 150J
Device: Placebo phototherapy - 300J
Device: Phototherapy through light emitting diode (LED) - 300J

Study type

Interventional

Funder types

Other

Identifiers

NCT01889784
13573013.1.0000.5504

Details and patient eligibility

About

The purpose of this study is to determine the phototherapy may be adjuvant to exercise to improve muscular efficiency and increase aerobic capacity. We hypothesized that phototherapy adjuvant with physical exercise may be benefit to populations with Diabetes mellitus that have impairment in cardiopulmonary fitness and low oxygen uptake peak values (VO2peak) in exercise tests. Two doses will be tested 150J and 300J. Additionally, this study aims to evaluate the effect of phototherapy previously applied to the exercise on the cardiovascular coupling. We hypothesize that phototherapy previously applied to the exercise will result in the increase baroreflex sensitivity (increased coherence and gain and decreased phase), promoting the improvement of the cardiovascular autonomic control and cardiovascular coupling in diabetic subjects. Two doses will be tested 150J and 300J.

Enrollment

60 estimated patients

Sex

Male

Ages

45 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • overt coronary disease
  • sedentary
  • Clinical diagnosis of diabetes mellitus
  • Free of diabetes mellitus to participate of control group

Exclusion criteria

  • autonomic neuropathy
  • Smoking
  • anemia
  • alcoholism
  • disability conditions precluding exercise

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

60 participants in 4 patient groups

Individuals with diabetes mellitus (phototherapy 150J)
Other group
Description:
The intervention of this study is phototherapy through light emitting diode (LED) and dose of 150J each muscle. The Effective-LED or Placebo-LED will be applied in femoral quadriceps and triceps surae muscles bilaterally before constant-load exercise tests in bike. Each individual will perform two tests with Effective-LED and two tests with Placebo-LED randomly allocated. Evaluations will be completed in 4 days in total, respecting 14 days of rest to ensure the long washout phototherapy.
Treatment:
Device: Phototherapy through light emitting diode (LED) - 150J
Device: Placebo phototherapy - 150J
Health individuals - 150J (phototherapy 150J)
Other group
Description:
The intervention of this study is phototherapy through light emitting diode (LED) and dose of 150J each muscle. The Effective-LED or Placebo-LED will be applied in femoral quadriceps and triceps surae muscle bilaterally before constant-load exercise tests in bike. Each individual will perform two tests with Effective-LED and two tests with Placebo-LED randomly allocated. Evaluations will be completed in 4 days in total, respecting 14 days of rest to ensure the long washout phototherapy.
Treatment:
Device: Phototherapy through light emitting diode (LED) - 150J
Device: Placebo phototherapy - 150J
Individuals with diabetes mellitus (phototherapy 300J)
Other group
Description:
The intervention of this study is phototherapy through light emitting diode (LED) with 300J. The Effective-LED or Placebo-LED will be applied in femoral quadriceps and triceps surale muscles bilaterally before constant-load exercise tests in bike. Each individual will perform two tests with Effective-LED and two tests with Placebo-LED randomly allocated. Evaluations will be completed in 4 days in total, respecting 14 days of rest to ensure the long washout phototherapy.
Treatment:
Device: Phototherapy through light emitting diode (LED) - 300J
Device: Placebo phototherapy - 300J
Health individuals (phototherapy 300J)
Other group
Description:
The intervention of this study is phototherapy through light emitting diode (LED). The Effective-LED or Placebo-LED will be applied in femoral quadriceps and triceps surae muscle bilaterally before constant-load exercise tests in bike. Each individual will perform two tests with Effective-LED and two tests with Placebo-LED randomly allocated. Evaluations will be completed in 4 days in total, respecting 14 days of rest to ensure the long washout phototherapy.
Treatment:
Device: Phototherapy through light emitting diode (LED) - 300J
Device: Placebo phototherapy - 300J

Trial contacts and locations

1

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Central trial contact

Renata Gonçalves, Physiotherapist; Cristina O Francisco, Master

Data sourced from clinicaltrials.gov

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