Phototherapy Applied in Combination With Aerobic Training

Phototherapy Applied in Combination With Aerobic Training: Evaluation of Different Irradiation Protocols

Interventional

Study Overview

• Status: Completed
• Conditions: Excessive Physical Exercise, Unspecified
• Intervention / Treatment: Device: Active and Active Phototherapy; Device: Active and Placebo Phototherapy; Device: Placebo and active Phototherapy; Device: Placebo and Placebo Phototherapy

Detailed Description

Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 01504-001
    • University of Nove de Julho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• There were included in the study
• healthy individuals,
• aged between 18 and 35 years old,
• presenting no history of musculoskeletal injury.
• that are not making use of pharmacological agents and / or nutritional supplements, and that have at least 80% of attendance to training.

Exclusion Criteria:

• present some musculoskeletal injury during the study
• cardiac ou pulmonary disease severe

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Group A; Active and Active Phototherapy The phototherapy was divided in program 1 and program 2. One of these programs consisted in active phototherapy and the other placebo. The subjects allocated in group A, received program 1 before aerobic training, and the same program 1 after training	Device: Active and Active Phototherapy; Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.; Device: Active and Placebo Phototherapy; Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.; Device: Placebo and active Phototherapy; Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.; Device: Placebo and Placebo Phototherapy; Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.
Experimental: Experimental: Group B; Active and Placebo Phototherapy The phototherapy was divided in program 1 and program 2. One of these programs consisted in active phototherapy and the other placebo. The subjects allocated in group B, received program 1 before aerobic training, and program 2 after training.	Device: Active and Active Phototherapy; Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.; Device: Active and Placebo Phototherapy; Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.; Device: Placebo and active Phototherapy; Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.; Device: Placebo and Placebo Phototherapy; Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.
Experimental: Experimental: Group C; Placebo and Active Phototherapy The phototherapy was divided in program 1 and program 2. One of these programs consisted in active phototherapy and the other placebo. The subjects allocated in group C, received program 2 before aerobic training, and program 1 after training.	Device: Active and Active Phototherapy; Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.; Device: Active and Placebo Phototherapy; Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.; Device: Placebo and active Phototherapy; Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.; Device: Placebo and Placebo Phototherapy; Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.
Experimental: Experimental: Group D; Placebo and Placebo Phototherapy The phototherapy was divided in program 1 and program 2. One of these programs consisted in active phototherapy and the other placebo. The subjects allocated in group B, received program 2 before strength training, and the same program 2 after training.	Device: Active and Active Phototherapy; Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.; Device: Active and Placebo Phototherapy; Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.; Device: Placebo and active Phototherapy; Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.; Device: Placebo and Placebo Phototherapy; Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time until exhaustion	ergoespirometry	change from baseline in the time until exhaustion at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum consumption of oxygen VO2	ergoespirometry	change from baseline in the Maximum consumption of oxygen at 12 weeks
Body fat	skinfold	change from baseline in the body fat at 12 weeks

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Study Chair: Ernesto Leal-Junior, PHD, Study Principal Investigator - Universidade Nove de Julho

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: July 18, 2016
• First Submitted That Met QC Criteria: August 17, 2016
• First Posted (Estimate): August 22, 2016

Study Record Updates

• Last Update Posted (Actual): April 27, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: sedentary lifestyle
• Other Study ID Numbers: LSantos, UniNove

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO