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Photobiomodulation, Cryotherapy Combined With Compression, and Massage for Recovery

Primary Purpose

Laser, Muscle; Fatigue, Heart, Muscle Damage

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Photobiomodulation; Cryotherapy, Massage
Sponsored by
Universidade Anhanguera
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Laser focused on measuring Photobiomodulation, Crossfit, Muscle Damage

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Filipe AbdallaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Sham Comparator

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

Photobiomodulation

Sham Photobiomodulation

Active Cryotherapy

Sham Cryotherapy

Massage

Sham Massage

Arm Description

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

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

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Muscle Force Dynamometry
participants will be evaluated regarding the dominant knee extensor torque during maximal voluntary isometric contraction (MVIC) in an extensor chair.
Blood markers of muscle damage and inflammatory process
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.
Delayed onset muscle pain
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.

Secondary Outcome Measures

Full Information

First Posted
March 2, 2022
Last Updated
November 15, 2022
Sponsor
Universidade Anhanguera
Collaborators
Universidade Federal de Sao Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT05627141
Brief Title
Photobiomodulation, Cryotherapy Combined With Compression, and Massage for Recovery
Official Title
Comparison Between Photobiomodulation, Cryotherapy Combined With Compression, and Massage for Muscle Recovery in Crossfit Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Anhanguera
Collaborators
Universidade Federal de Sao Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Skeletal muscle fatigue is an inevitable phenomenon in the training and competition routine for many crossfit athletes, which can impair their physical performance and predispose them to musculoskeletal injuries. Thus, strategies and/or therapies that minimize fatigue and accelerate muscle recovery are extremely relevant for everyone involved with sport. The aim of the present study is to investigate and compare the effects of photobiomodulation, cryotherapy combined with compression, and massage as isolated therapies for muscle recovery after a protocol of induced muscle damage and fatigue in Crossfit athletes. This is a randomized, double-blind, crossover, sham-controlled clinical trial. Will be recruited 60 male participants, adults, aged between 18 and 40 years, Crossfit practitioners. They will be randomly allocated into 3 groups of 20 participants per therapy, each crossed between effective and sham every 15 days. The primary outcome will be muscle performance in functional test (free squat) and knee extensor torque in maximal voluntary isometric contraction (MVIC). Secondary outcomes will be evaluated by the levels of muscle damage via creatine phosphokinase (CPK) and inflammatory process via blood C-reactive protein (CRP); and delayed onset muscle pain via numerical verbal scale (0-10). All outcomes will be evaluated at baseline, 24h and 48h after induction of muscle damage and fatigue. Data will be analyzed and compared intra and inter groups with a significance level of 5%.
Detailed Description
This is a randomized, double-blind, crossover, controlled clinical trial of sham therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laser, Muscle; Fatigue, Heart, Muscle Damage
Keywords
Photobiomodulation, Crossfit, Muscle Damage

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Photobiomodulation
Arm Type
Experimental
Arm Description
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
Arm Title
Sham Photobiomodulation
Arm Type
Sham Comparator
Arm Description
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
Arm Title
Active Cryotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Cryotherapy
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Massage
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Massage
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Photobiomodulation; Cryotherapy, Massage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle Force Dynamometry
Description
participants will be evaluated regarding the dominant knee extensor torque during maximal voluntary isometric contraction (MVIC) in an extensor chair.
Time Frame
48 hours
Title
Blood markers of muscle damage and inflammatory process
Description
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.
Time Frame
48 hours
Title
Delayed onset muscle pain
Description
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.
Time Frame
48 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Filipe A dos Reis, PhD
Phone
5567992076011
Email
filipeabdalla@icloud.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filipe A dos Reis, PhD
Organizational Affiliation
Ufscar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Filipe Abdalla
City
Campo Grande
State/Province
Mato Grosso Do Sul
ZIP/Postal Code
79117504
Country
Brazil
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Photobiomodulation, Cryotherapy Combined With Compression, and Massage for Recovery

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