- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05627141
Photobiomodulation, Cryotherapy Combined With Compression, and Massage for Recovery
Comparison Between Photobiomodulation, Cryotherapy Combined With Compression, and Massage for Muscle Recovery in Crossfit Athletes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Mato Grosso do Sul
-
Campo Grande, Mato Grosso do Sul, Brazil, 79117504
- Filipe Abdalla
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male participants;
- Adults; aged between 18 and 40 years;
- Body mass index (BMI) between 18 and 30 kg/m2;
- Crossfit practitioners of the scale, amateur, RX and elite categories;
- Training at least 5 days a week.
Exclusion Criteria:
- Orthopedic injuries in the lower limbs (2 months) or during the development of the study will be excluded;
- Participants with less than 5 training sessions per week;
- Participants making regular use of pharmacological agents and/or ergogenic supplements;
- Participants who regularly use alcohol and/or tobacco;
- Participants with skin lesions (open wounds) on the lower limbs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Photobiomodulation
10 participants will receive active photobiomodulation immediately after the muscle damage and fatigue induction protocol in a randomized and crossover manner, with an interval of 15 days between each evaluation session
|
Photobiomodulation: the 20 participants will receive active photobiomodulation or sham immediately after the muscle damage and fatigue induction protocol in a randomized and crossover manner, with an interval of 15 days between each evaluation session. Cryotherapy combined with compression: the 20 participants will receive effective cryotherapy (10-12°C for 20 min) combined with high compression, or sham (25°C for 20 min) combined with light compression, on the lower limbs, immediately after the protocol. induction of muscle damage and fatigue. Effective cryotherapy or sham will be applied in a randomized and crossover manner, with an interval of 15 days between each evaluation session. Massage: the 20 participants will receive the effective massage or sham immediately after the muscle damage and fatigue induction protocol in a randomized and crossover manner, with an interval of 15 days between each evaluation session. |
|
Sham Comparator: Sham Photobiomodulation
10 participants will receive sham photobiomodulation immediately after the muscle damage and fatigue induction protocol in a randomized and crossover manner, with an interval of 15 days between each evaluation session
|
Photobiomodulation: the 20 participants will receive active photobiomodulation or sham immediately after the muscle damage and fatigue induction protocol in a randomized and crossover manner, with an interval of 15 days between each evaluation session. Cryotherapy combined with compression: the 20 participants will receive effective cryotherapy (10-12°C for 20 min) combined with high compression, or sham (25°C for 20 min) combined with light compression, on the lower limbs, immediately after the protocol. induction of muscle damage and fatigue. Effective cryotherapy or sham will be applied in a randomized and crossover manner, with an interval of 15 days between each evaluation session. Massage: the 20 participants will receive the effective massage or sham immediately after the muscle damage and fatigue induction protocol in a randomized and crossover manner, with an interval of 15 days between each evaluation session. |
|
Experimental: Active Cryotherapy
10 participants will receive effective cryotherapy (10-12°C for 20 min) combined with high compression on the lower limbs, or sham (25°C for 20 min) damage and fatigue induction protocol.
muscle.
|
Photobiomodulation: the 20 participants will receive active photobiomodulation or sham immediately after the muscle damage and fatigue induction protocol in a randomized and crossover manner, with an interval of 15 days between each evaluation session. Cryotherapy combined with compression: the 20 participants will receive effective cryotherapy (10-12°C for 20 min) combined with high compression, or sham (25°C for 20 min) combined with light compression, on the lower limbs, immediately after the protocol. induction of muscle damage and fatigue. Effective cryotherapy or sham will be applied in a randomized and crossover manner, with an interval of 15 days between each evaluation session. Massage: the 20 participants will receive the effective massage or sham immediately after the muscle damage and fatigue induction protocol in a randomized and crossover manner, with an interval of 15 days between each evaluation session. |
|
Sham Comparator: Sham Cryotherapy
10 participants will receive sham cryotherapy (25°C for 20 min) combined with light compression on the lower limbs immediately after the damage and fatigue induction protocol.
muscle.
|
Photobiomodulation: the 20 participants will receive active photobiomodulation or sham immediately after the muscle damage and fatigue induction protocol in a randomized and crossover manner, with an interval of 15 days between each evaluation session. Cryotherapy combined with compression: the 20 participants will receive effective cryotherapy (10-12°C for 20 min) combined with high compression, or sham (25°C for 20 min) combined with light compression, on the lower limbs, immediately after the protocol. induction of muscle damage and fatigue. Effective cryotherapy or sham will be applied in a randomized and crossover manner, with an interval of 15 days between each evaluation session. Massage: the 20 participants will receive the effective massage or sham immediately after the muscle damage and fatigue induction protocol in a randomized and crossover manner, with an interval of 15 days between each evaluation session. |
|
Experimental: Massage
10 participants will receive the effective massage immediately after the muscle damage and fatigue induction protocol in a randomized and crossover manner, with an interval of 15 days between each evaluation session.
|
Photobiomodulation: the 20 participants will receive active photobiomodulation or sham immediately after the muscle damage and fatigue induction protocol in a randomized and crossover manner, with an interval of 15 days between each evaluation session. Cryotherapy combined with compression: the 20 participants will receive effective cryotherapy (10-12°C for 20 min) combined with high compression, or sham (25°C for 20 min) combined with light compression, on the lower limbs, immediately after the protocol. induction of muscle damage and fatigue. Effective cryotherapy or sham will be applied in a randomized and crossover manner, with an interval of 15 days between each evaluation session. Massage: the 20 participants will receive the effective massage or sham immediately after the muscle damage and fatigue induction protocol in a randomized and crossover manner, with an interval of 15 days between each evaluation session. |
|
Sham Comparator: Sham Massage
10 participants will receive the sham massage immediately after the muscle damage and fatigue induction protocol in a randomized and crossover manner, with an interval of 15 days between each evaluation session.
|
Photobiomodulation: the 20 participants will receive active photobiomodulation or sham immediately after the muscle damage and fatigue induction protocol in a randomized and crossover manner, with an interval of 15 days between each evaluation session. Cryotherapy combined with compression: the 20 participants will receive effective cryotherapy (10-12°C for 20 min) combined with high compression, or sham (25°C for 20 min) combined with light compression, on the lower limbs, immediately after the protocol. induction of muscle damage and fatigue. Effective cryotherapy or sham will be applied in a randomized and crossover manner, with an interval of 15 days between each evaluation session. Massage: the 20 participants will receive the effective massage or sham immediately after the muscle damage and fatigue induction protocol in a randomized and crossover manner, with an interval of 15 days between each evaluation session. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Force Dynamometry
Time Frame: 48 hours
|
participants will be evaluated regarding the dominant knee extensor torque during maximal voluntary isometric contraction (MVIC) in an extensor chair.
|
48 hours
|
|
Blood markers of muscle damage and inflammatory process
Time Frame: 48 hours
|
To measure the serum levels of CPK and CRP, blood samples will be collected after aseptic cleaning of the ventral side of the dominant arm.
All blood collection procedures will be performed by a qualified nurse (who will not know to which group each participant will belong).
Collections will be performed using vacuum collection tubes, without anticoagulant (10ml), centrifuged at 4,000g for 5 minutes, and stored at -80°C until analysis.
Blood collections will be performed at baseline (before WOD and leg extension exercise), 24h and 48h after.
Blood analysis will be performed using infrared spectrophotometry in a clinical analysis laboratory (Matter Diagnósticos, Campo Grande, MS) and by an evaluator who is blinded to the therapies applied.
|
48 hours
|
|
Delayed onset muscle pain
Time Frame: 48 hours
|
The subjective perception of pain will be through a numerical verbal scale (NVS) graduated in centimeters (from 0 to 10), where 0 corresponds to no pain, and 10 corresponds to the maximum possible pain (HAWKER et al., 2011).
Pain will be provoked in participants through CIVM for knee extension of the dominant lower limb, in full extension (0°) and without load (FERRARESI et al., 2016).
Volunteers will be asked about the level of pain they will feel immediately before WOD and MVIC in a leg extension, 24h and 48h after.
|
48 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Filipe A dos Reis, PhD, Ufscar
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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