Trial Outcomes & Findings for Effect of Whole-body Photobiomodulation on Muscular Performance Enhancement. (NCT NCT05989815)

NCT ID: NCT05989815

Last Updated: 2025-11-10

Results Overview

Mean serum creatine phosphokinase (CK) concentration (U/L), calculated as the average of four time points: Baseline, 24h, 48h, and 72h post-exercise. Higher values indicate greater muscle damage.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Average of Baseline, 24h, 48h, and 72h

Results posted on

2025-11-10

Participant Flow

Participants with injuries that prevented them from practicing sports were excluded.

Participant milestones

Participant milestones
Measure
PBMT Post Muscle Damage Protocol (PBMT-post)
Group submitted to pre-exercise Sham (placebo) photobiomodulation therapy (PBMT), and post-exercise active PBMT.
PBMT Pre (PBMT-pre)
Group submitted to pre-exercise active photobiomodulation therapy (PBMT), and post-exercise Sham (placebo) PBMT.
PBMT Placebo (PBMT-sham)
Group submitted to pre-exercise and post-exercise photobiomodulation therapy (PBMT) Sham (placebo).
Overall Study
STARTED
10
10
10
Overall Study
COMPLETED
10
10
10
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Whole-body Photobiomodulation on Muscular Performance Enhancement.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
PBMT Post Muscle Damage Protocol (PBMT-post)
n=10 Participants
Group submitted to pre-exercise Sham (placebo) photobiomodulation therapy (PBMT), and post-exercise active PBMT.
PBMT Pre (PBMT-pre)
n=10 Participants
Group submitted to pre-exercise active photobiomodulation therapy (PBMT), and post-exercise Sham (placebo) PBMT.
PBMT Placebo (PBMT-sham)
n=10 Participants
Group submitted to pre-exercise and post-exercise photobiomodulation therapy (PBMT) Sham (placebo).
Total
n=30 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=28 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
n=5 Participants
10 Participants
n=20 Participants
10 Participants
n=40 Participants
30 Participants
n=28 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=28 Participants
Age, Continuous
20 years
STANDARD_DEVIATION 1 • n=5 Participants
20 years
STANDARD_DEVIATION 1 • n=20 Participants
20 years
STANDARD_DEVIATION 1 • n=40 Participants
20 years
STANDARD_DEVIATION 1 • n=28 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=28 Participants
Sex: Female, Male
Male
10 Participants
n=5 Participants
10 Participants
n=20 Participants
10 Participants
n=40 Participants
30 Participants
n=28 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=28 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=28 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=28 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=28 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=28 Participants
Race (NIH/OMB)
More than one race
10 Participants
n=5 Participants
10 Participants
n=20 Participants
10 Participants
n=40 Participants
30 Participants
n=28 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=28 Participants
Region of Enrollment
Brazil
10 participants
n=5 Participants
10 participants
n=20 Participants
10 participants
n=40 Participants
30 participants
n=28 Participants

PRIMARY outcome

Timeframe: Average of Baseline, 24h, 48h, and 72h

Mean serum creatine phosphokinase (CK) concentration (U/L), calculated as the average of four time points: Baseline, 24h, 48h, and 72h post-exercise. Higher values indicate greater muscle damage.

Outcome measures

Outcome measures
Measure
PBMT Pre (PBMT-pre)
n=10 Participants
Group submitted to pre-exercise active photobiomodulation therapy (PBMT), and post-exercise Sham (placebo) PBMT.
PBMT Placebo (PBMT-sham)
n=10 Participants
Group submitted to pre-exercise and post-exercise photobiomodulation therapy (PBMT) Sham (placebo).
PBMT Post Muscle Damage Protocol (PBMT-post)
n=10 Participants
Group submitted to pre-exercise Sham (placebo) photobiomodulation therapy (PBMT), and post-exercise active PBMT.
Measurement of Blood Levels of Creatine Phosphokinase (CK)
249.2 U/L
Standard Deviation 112.28
289.2 U/L
Standard Deviation 209.94
287.8 U/L
Standard Deviation 199.09

SECONDARY outcome

Timeframe: Average of Baseline, 24h, 48h, 72h

Vertical jump height (cm) measured by the Squat Jump (SJ) test. Mean of four time points: Baseline, 24h, 48h, and 72h after the protocol. Higher values indicate better performance.

Outcome measures

Outcome measures
Measure
PBMT Pre (PBMT-pre)
n=10 Participants
Group submitted to pre-exercise active photobiomodulation therapy (PBMT), and post-exercise Sham (placebo) PBMT.
PBMT Placebo (PBMT-sham)
n=10 Participants
Group submitted to pre-exercise and post-exercise photobiomodulation therapy (PBMT) Sham (placebo).
PBMT Post Muscle Damage Protocol (PBMT-post)
n=10 Participants
Group submitted to pre-exercise Sham (placebo) photobiomodulation therapy (PBMT), and post-exercise active PBMT.
Squat Jump (SJ) Height
38.91 cm
Standard Deviation 5.45
38.56 cm
Standard Deviation 4.09
37.38 cm
Standard Deviation 5.22

SECONDARY outcome

Timeframe: Average of Baseline, 24h, 48h, and 72h

Peak isometric force (kgf) of knee extensors, measured with handheld dynamometry. Mean of Baseline, 24h, 48h, and 72h after exercise. Higher values indicate better performance.

Outcome measures

Outcome measures
Measure
PBMT Pre (PBMT-pre)
n=10 Participants
Group submitted to pre-exercise active photobiomodulation therapy (PBMT), and post-exercise Sham (placebo) PBMT.
PBMT Placebo (PBMT-sham)
n=10 Participants
Group submitted to pre-exercise and post-exercise photobiomodulation therapy (PBMT) Sham (placebo).
PBMT Post Muscle Damage Protocol (PBMT-post)
n=10 Participants
Group submitted to pre-exercise Sham (placebo) photobiomodulation therapy (PBMT), and post-exercise active PBMT.
Muscle Performance Tests - Dynamometry
53.45 kgf (kilogram-force)
Standard Deviation 8.63
55.58 kgf (kilogram-force)
Standard Deviation 10.45
59.19 kgf (kilogram-force)
Standard Deviation 8.34

SECONDARY outcome

Timeframe: Average of Baseline, 24h, 48h, and 72h

DOMS intensity assessed using a Numeric Rating Scale (NRS; 0-10), where 0 = no soreness and 10 = worst possible soreness during knee extension. Higher scores indicate greater soreness. Mean of Baseline, 24h, 48h, and 72h post-protocol.

Outcome measures

Outcome measures
Measure
PBMT Pre (PBMT-pre)
n=10 Participants
Group submitted to pre-exercise active photobiomodulation therapy (PBMT), and post-exercise Sham (placebo) PBMT.
PBMT Placebo (PBMT-sham)
n=10 Participants
Group submitted to pre-exercise and post-exercise photobiomodulation therapy (PBMT) Sham (placebo).
PBMT Post Muscle Damage Protocol (PBMT-post)
n=10 Participants
Group submitted to pre-exercise Sham (placebo) photobiomodulation therapy (PBMT), and post-exercise active PBMT.
Delayed Onset Muscle Soreness (DOMS)
3.80 points on NRS (0-10)
Standard Deviation 2.74
5.70 points on NRS (0-10)
Standard Deviation 2.05
3.00 points on NRS (0-10)
Standard Deviation 2.00

SECONDARY outcome

Timeframe: Average of Baseline, 24h, 48h, 72h

Vertical jump height (cm) measured by the Countermovement Jump (CMJ) test. Mean of four time points: Baseline, 24h, 48h, and 72h after the protocol. Higher values indicate better performance.

Outcome measures

Outcome measures
Measure
PBMT Pre (PBMT-pre)
n=10 Participants
Group submitted to pre-exercise active photobiomodulation therapy (PBMT), and post-exercise Sham (placebo) PBMT.
PBMT Placebo (PBMT-sham)
n=10 Participants
Group submitted to pre-exercise and post-exercise photobiomodulation therapy (PBMT) Sham (placebo).
PBMT Post Muscle Damage Protocol (PBMT-post)
n=10 Participants
Group submitted to pre-exercise Sham (placebo) photobiomodulation therapy (PBMT), and post-exercise active PBMT.
Countermovement Jump (CMJ) Height
41.56 cm
Standard Deviation 6.73
40.55 cm
Standard Deviation 4.28
39.36 cm
Standard Deviation 4.27

Adverse Events

PBMT Post Muscle Damage Protocol (PBMT-post)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

PBMT Pre (PBMT-pre)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

PBMT Placebo (PBMT-sham)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Italo Amaral de Oliveira, Principal Investigator

Federal University of São Carlos (UFSCar)

Phone: +55 19 99719-0361

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place