Excessive Physical Exercise, UnspecifiedNCT02874976
Phototherapy Applied in Combination With Aerobic Training
A study testing Active and Active Phototherapy in people with Excessive Physical Exercise, Unspecified, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Interventional Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Excessive Physical Exercise, Unspecified
- What is being tested?
- Active and Active Phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteBrazil
- Study dates
- May 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- present some musculoskeletal injury during the study
- cardiac ou pulmonary disease severe
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phototherapy Applied in Combination With Aerobic Training: Evaluation of Different Irradiation Protocols
Interventional
Read the 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
- Conditions
- Excessive Physical Exercise, Unspecified
- Being tested
- Active and Active Phototherapy, Active and Placebo Phototherapy, Placebo and active Phototherapy, Placebo and Placebo Phototherapy
- Keywords
- sedentary lifestyle
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active and Active PhototherapyDevice
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 PhototherapyDevice
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 PhototherapyDevice
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 PhototherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Active and Active Phototherapy; Device: Active and Placebo Phototherapy; Device: Placebo and active Phototherapy; Device: 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. Receives: Device: Active and Active Phototherapy; Device: Active and Placebo Phototherapy; Device: Placebo and active Phototherapy; Device: 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. Receives: Device: Active and Active Phototherapy; Device: Active and Placebo Phototherapy; Device: Placebo and active Phototherapy; Device: 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. Receives: Device: Active and Active Phototherapy; Device: Active and Placebo Phototherapy; Device: Placebo and active Phototherapy; Device: Placebo and Placebo Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until exhaustion
ergoespirometry
Measured: change from baseline in the time until exhaustion at 12 weeks
Secondary outcomes (2)
Maximum consumption of oxygen VO2
ergoespirometry
Measured: change from baseline in the Maximum consumption of oxygen at 12 weeks
Body fat
skinfold
Measured: change from baseline in the body fat at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startMay 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Physical Exercise, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Larissa Aline Santos, University of Nove de Julho
- Investigators
- Ernesto Leal-Junior, PHD, Study chair, Study Principal Investigator - Universidade Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874976
- Sponsor's protocol ID
- LSantos, UniNove
- Status last verified
- Apr 2017
- First submitted
- 18 Jul 2016
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phototherapy Applied in Combination With Aerobic Training: Evaluation of Different Irradiation Protocols
- ClinicalTrials.gov ID
- NCT02874976
- Acronym / sponsor ID
- LSantos, UniNove
- Conditions
- Excessive Physical Exercise, Unspecified
- Keywords
- sedentary lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- May 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Interventional
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental: Group A | Experimental | Device: Active and Active Phototherapy, Device: Active and Placebo Phototherapy, Device: Placebo and active Phototherapy, Device: Placebo and Placebo PhototherapyActive 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 |
| Experimental: Group B | Experimental | Device: Active and Active Phototherapy, Device: Active and Placebo Phototherapy, Device: Placebo and active Phototherapy, Device: Placebo and Placebo PhototherapyActive 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. |
| Experimental: Group C | Experimental | Device: Active and Active Phototherapy, Device: Active and Placebo Phototherapy, Device: Placebo and active Phototherapy, Device: Placebo and Placebo PhototherapyPlacebo 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. |
| Experimental: Group D | Experimental | Device: Active and Active Phototherapy, Device: Active and Placebo Phototherapy, Device: Placebo and active Phototherapy, Device: Placebo and Placebo PhototherapyPlacebo 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- present some musculoskeletal injury during the study
- cardiac ou pulmonary disease severe
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active and Active PhototherapyParticipants 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 | Experimental: Group A, Experimental: Group B, Experimental: Group C, Experimental: Group D |
| Active and Placebo PhototherapyParticipants 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 | Experimental: Group A, Experimental: Group B, Experimental: Group C, Experimental: Group D |
| Placebo and active PhototherapyParticipants 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 | Experimental: Group A, Experimental: Group B, Experimental: Group C, Experimental: Group D |
| Placebo and Placebo PhototherapyParticipants 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 | Experimental: Group A, Experimental: Group B, Experimental: Group C, Experimental: Group D |
Primary outcome
Time until exhaustion
Time frame: change from baseline in the time until exhaustion at 12 weeks
ergoespirometry
2 secondary outcomes
Maximum consumption of oxygen VO2
Time frame: change from baseline in the Maximum consumption of oxygen at 12 weeks
Body fat
Time frame: change from baseline in the body fat at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernesto Leal-Junior, PHD study chair
Study Principal Investigator - Universidade Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active and Active Phototherapy in people with Excessive Physical Exercise, Unspecified, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time until exhaustion (time frame: change from baseline in the time until exhaustion at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.