Neuromuscular Responses to Recovery Techniques

June 16, 2024 updated by: Alex Buoite Stella, University of Trieste

Effects of Cold Water Immersion and Percussive Gun Massage on Recovery Measures in Soccer Players

Cold water immersion (CWI) and percussive massage therapy (PMT) are commonly used re-covery techniques in team sports. In particular, despite its wide use, PMT has been scarcely investigated in the literature, especially regarding neuromuscular measures and in comparison with other techniques. This study aims to evaluate and compare the acute and short-term ef-fects (24 h) of CWI and PMT on muscle strength, contractile properties, and soreness after exercise. A randomized crossover study will be performed on sixteen male soccer players (22 y, 20-27) who participate in three experimental sessions involving high-intensity training and 12-min recovery including CWI (10 °C water), bilateral PMT on the anterior and posterior thigh, or passive resting. Outcomes will be assessed immediately after the exercise protocol, after the recovery intervention, and at 24 h. Isometric knee extension (IKE) and flexion (IKF), and tensiomyography (TMG) will be assessed.Muscle soreness and fatigue will be scored from 0 to 10.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants will be invited to participate to a cross-over randomized trial, consisting in 3 experimental sessions at 7 days of distance one from another. During each experimental session, participants will be asked to train for about 45 min at a high-intensity protocol (High-Intensity Intermittent Running, plyometric jumps and isometric chair position). After the exercise, participants will be assessed for neuromuscular function (isometric strength and tensiomyography) as well as perceived soreness and fatigue. Then, in a randomized order, participants will receive three different recovery interventions: cold water immersion, percussive massage, or a passive control condition. After the recovery intervention, outcomes are assessed again, as well as at 24 h. Isometric strength is assessed with a dynamometer during knee extension and knee flexion. Tensiomyography is performed on the thigh muscles, and time to contraction and radial displacement are considered as outcomes. Soreness and fatigue are rated by the participant from 0 to 10.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Trieste, Italy, 34100
        • CdL in Fisioterapia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • being healthy
  • training in soccer for more than 3 years and with a training frequency > 2 times/week

Exclusion Criteria:

  • reported time-loss injuries
  • using analgesics or other therapies affecting muscle function or pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CWI
The CWI protocol consists of participants standing, with only their underwear and a t-shirt, in a portable tub for cold water therapy (Qryo, Italy), with the water to their hips being constantly maintained at 10±0.5 °C by a cooling system that pumped and stirred the water inside the tub and around the participant's lower limbs. Water temperature and the duration of the immersion, which is 12 minutes for all the participants considering they were characterized by similar anthropometrics and body composition, were based on previous literature
Other: Cold Water Immersion
Cold water immersion consists in 12 min standing in 10 °C water
Experimental: PMT
The PMT protocol is performed with the application of a percussive therapy gun (Theragun Elite, Therabody, USA). The participants rests with their underwear and a t-shirt on a treatment bed, and the percussive therapy gun with a "standard ball", 16 mm amplitude of percussions, and a frequency of 30 Hz, is applied to the thigh muscles of both lower limbs, 3 min on the anterior and 3 min on the posterior area of each thigh. The protocol is based on previous literature and adapted to the specific aims of this study.
Device: Percussive Massage Therapy
Percussive massage therapy is performed with a massage gun on the thigh muscles for 12 min
No Intervention: PAS
The control condition (PAS) consists of participants resting on a chair for 12 minutes in a quiet room at 25 °C.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Muscle soreness
Time Frame: Within 10 minutes from exercise cessation (Post-Exercise); Within 10 minutes after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)
Subjective evalutation of muscle soreness from 0 to 10 with a numeric rating scale (NRS), where 0 is no soreness at all, and 10 is unbearable soreness
Within 10 minutes from exercise cessation (Post-Exercise); Within 10 minutes after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)
Muscle fatigue
Time Frame: Within 10 minutes from exercise cessation (Post-Exercise); Within 10 minutes after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)
Subjective evaluation of muscle fatigue from 0 to 10 with a numeric rating scale (NRS), where 0 is no fatigue at all, and 10 is unbearable fatigue
Within 10 minutes from exercise cessation (Post-Exercise); Within 10 minutes after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Isometric muscle strength
Time Frame: Within 10 minutes from exercise cessation (Post-Exercise); Within 10 minutes after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)
Isometric knee extension (IKE) and flexion (IKF) strength assessments performed on a treatment bed, with a digital handheld dynamometer
Within 10 minutes from exercise cessation (Post-Exercise); Within 10 minutes after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)
Tensiomyography
Time Frame: Within 10 minutes from exercise cessation (Post-Exercise); Within 10 minutes after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)
Tensiomyography (TMG) will be performed on anterior and posterior thigh muscles
Within 10 minutes from exercise cessation (Post-Exercise); Within 10 minutes after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Trieste

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Fisioterapia1705

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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