NCT02874976

Brief Summary

Interventional

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

11 months

First QC Date

July 18, 2016

Last Update Submit

April 25, 2017

Conditions

Keywords

sedentary lifestyle

Outcome Measures

Primary Outcomes (1)

  • Time until exhaustion

    ergoespirometry

    change from baseline in the time until exhaustion at 12 weeks

Secondary Outcomes (2)

  • Maximum consumption of oxygen VO2

    change from baseline in the Maximum consumption of oxygen at 12 weeks

  • Body fat

    change from baseline in the body fat at 12 weeks

Study Arms (4)

Experimental: Group A

EXPERIMENTAL

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 PhototherapyDevice: Active and Placebo PhototherapyDevice: Placebo and active PhototherapyDevice: Placebo and Placebo Phototherapy

Experimental: Group B

EXPERIMENTAL

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 PhototherapyDevice: Active and Placebo PhototherapyDevice: Placebo and active PhototherapyDevice: Placebo and Placebo Phototherapy

Experimental: Group C

EXPERIMENTAL

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 PhototherapyDevice: Active and Placebo PhototherapyDevice: Placebo and active PhototherapyDevice: Placebo and Placebo Phototherapy

Experimental: Group D

EXPERIMENTAL

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 PhototherapyDevice: Active and Placebo PhototherapyDevice: Placebo and active PhototherapyDevice: Placebo and Placebo Phototherapy

Interventions

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: Group AExperimental: Group BExperimental: Group CExperimental: Group D

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: Group AExperimental: Group BExperimental: Group CExperimental: Group D

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: Group AExperimental: Group BExperimental: Group CExperimental: Group D

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: Group AExperimental: Group BExperimental: Group CExperimental: Group D

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nove de Julho

São Paulo, 01504-001, Brazil

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ernesto Leal-Junior, PHD

    Study Principal Investigator - Universidade Nove de Julho

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Diretor, Ernesto Leal Junior, PhD

Study Record Dates

First Submitted

July 18, 2016

First Posted

August 22, 2016

Study Start

May 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

April 27, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations