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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02874976
Other study ID # LSantos, UniNove
Secondary ID
Status Completed
Phase N/A
First received July 18, 2016
Last updated April 25, 2017
Start date May 2016
Est. completion date April 2017

Study information

Verified date April 2017
Source University of Nove de Julho
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Interventional


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


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Excessive Physical Exercise, Unspecified

Intervention

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.
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.
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.
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.

Locations

Country Name City State
Brazil University of Nove de Julho Sao Paulo

Sponsors (2)

Lead Sponsor Collaborator
University of Nove de Julho Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time until exhaustion ergoespirometry change from baseline in the time until exhaustion at 12 weeks
Secondary Maximum consumption of oxygen VO2 ergoespirometry change from baseline in the Maximum consumption of oxygen at 12 weeks
Secondary Body fat skinfold change from baseline in the body fat at 12 weeks
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