Recovery Optimization Intervention to Reduce the Risk of Injuries in Soccer Players

April 2, 2025 updated by: University of Castilla-La Mancha

The goal of this clinical trial is to evaluate if recovery interventions using cold and hot water immersion can reduce the risk of injuries in amateur soccer players.

The main questions it aims to answer are:

Do cold water immersions reduce muscle fatigue and improve performance more effectively than hot water immersions? What is the optimal timing and duration for these recovery interventions to maximize their effectiveness?

Researchers will compare:

Cold Water Immersion (CWI) Hot Water Immersion (HWI) No Immersion (NI) Thermographic Immersion (TI) based on individual thermal profiles

Participants will:

Undergo thermographic assessments to determine their thermal profiles. Perform physical tests such as isometric strength tests, countermovement jumps (CMJ), and squats with 50% body weight.

Complete wellness questionnaires to assess their subjective recovery and fatigue levels.

Provide blood and urine samples for biomarker analysis. Participate in recovery interventions (CWI, HWI, or TI) based on their assigned group.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • 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 Contact

Study Contact Backup

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Age: Participants must be adults (18 years or older). Gender: Both male and female participants are eligible. Sport: Participants must be amateur football players. Team Membership: Participants must be members of a football team in the Castilla-La Mancha regional category.

Consent: Participants must provide written informed consent to participate in the study.

Health: Participants must be in good general health, with no chronic illnesses or conditions that would contraindicate participation in physical activity or water immersion.

Exclusion Criteria:

Injury: Participants who have sustained an injury that prevents them from participating in football activities for at least two weeks during any of the study blocks.

Medical Conditions: Participants with medical conditions that contraindicate water immersion (e.g., severe cardiovascular conditions, open wounds, skin infections).

Withdrawal: Participants who choose to withdraw from the study at any point. Non-compliance: Participants who do not comply with the study protocol or fail to attend scheduled sessions.

Pregnancy: Female participants who are pregnant or planning to become pregnant during the study period.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cold Water Immersion (CWI)
Participants undergo five intermittent immersions of 2 minutes each in cold water (11°C), with 2-minute rest periods in between.
Other: Cold Water Immersion (CWI)
Participants undergo five intermittent immersions of 2 minutes each in cold water (11°C), with 2-minute rest periods in between.
Other Names:
  • Intermittent Cold Water Immersion (11ºC)
Experimental: Hot Water Immersion (HWI)
Participants undergo a continuous immersion of 18 minutes in hot water (38°C).
Other: Hot water immersion (HWI)
Participants undergo a continuous immersion of 18 minutes in hot water (38°C)
Other Names:
  • Continuous hot water immersion (38ºC)
No Intervention: No Immersion (NI)
Participants follow the same protocol structure without any immersion.
Experimental: Thermography-Guided Immersion (TI)
Based on thermographic assessments, participants with a hypothermic profile (decreased temperature) receive hot water immersion, while those with a hyperthermic profile (increased temperature) receive cold water immersion.
Other: Thermography-Guided Immersion (TI)
Based on thermographic assessments, participants with a hypothermic profile (decreased temperature) receive hot water immersion, while those with a hyperthermic profile (increased temperature) receive cold water immersion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Fatigue Reduction:
Time Frame: From pre-intervention to 48 hours post-intervention
Evaluated through changes in biomarkers such as creatine kinase (CK), lactate dehydrogenase (LDH), and myoglobin levels, measured at multiple time points (pre- and post-intervention).
From pre-intervention to 48 hours post-intervention
Countermovement Jump (CMJ) test
Time Frame: From pre-intervention to 48 hours post-intervention.
Assessed using the countermovement jump (CMJ) test (cm)
From pre-intervention to 48 hours post-intervention.
Isometric Strenght Test (Hamstrings)
Time Frame: From pre-intervention to 48 hours post-intervention.
Assessed using isometric strength tests for the hamstrings (N)
From pre-intervention to 48 hours post-intervention.
Isometric Strenght Test (Adductor)
Time Frame: From pre-intervention to 48 hours post-intervention.
Assessed using isometric strength tests for the adductors (N)
From pre-intervention to 48 hours post-intervention.
Squat Performance
Time Frame: From pre-intervention to 48 hours post-intervention.
Assessed using squat performance with 50% body weight (reps)
From pre-intervention to 48 hours post-intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Recovery
Time Frame: At 24 and 48 hours post-intervention.

Description: Assessed using the Wellness Questionnaire, which includes questions on perceived recovery.

Unit of Measure: Score on a scale (1-10) Details: Higher scores indicate better perceived recovery.
At 24 and 48 hours post-intervention.
Stress Levels
Time Frame: At 24 and 48 hours post-intervention.

Description: Assessed using the Wellness Questionnaire, which includes questions on stress levels.

Unit of Measure: Score on a scale (1-10) Details: Higher scores indicate higher stress levels.
At 24 and 48 hours post-intervention.
Fatigue
Time Frame: At 24 and 48 hours post-intervention.

Description: Assessed using the Wellness Questionnaire, which includes questions on fatigue.

Unit of Measure: Score on a scale (1-10) Details: Higher scores indicate higher levels of fatigue.
At 24 and 48 hours post-intervention.
Muscle Soreness
Time Frame: At 24 and 48 hours post-intervention.

Description: Assessed using the Wellness Questionnaire, which includes questions on muscle soreness.

Unit of Measure: Score on a scale (1-10) Details: Higher scores indicate higher levels of muscle soreness.
At 24 and 48 hours post-intervention.
Sleep Quality
Time Frame: At 24 and 48 hours post-intervention.

Description: Assessed using the Wellness Questionnaire, which includes questions on sleep quality.

Unit of Measure: Score on a scale (1-10) Details: Higher scores indicate better sleep quality.
At 24 and 48 hours post-intervention.
Overall Well-Being
Time Frame: At 24 and 48 hours post-intervention.

Description: Assessed using the Wellness Questionnaire, which includes questions on overall well-being.

Unit of Measure: Score on a scale (1-10) Details: Higher scores indicate better overall well-being.
At 24 and 48 hours post-intervention.
Thermographic Assessments
Time Frame: From pre-intervention to 48 hours post-intervention.
Monitoring skin temperature changes using thermography to evaluate the effectiveness of the recovery interventions.
From pre-intervention to 48 hours post-intervention.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Injury Risk Assessment
Time Frame: From baseline (enrollment) to 24 weeks post-intervention.
Examining the association between recovery interventions and injury risk, based on the incidence of injuries recorded during the study period.
From baseline (enrollment) to 24 weeks post-intervention.
Concentration of 3-Methylhistidine in Urine
Time Frame: From pre-intervention to 48 hours post-intervention.

Description: Additional analysis of urine samples for markers such as 3-methylhistidine to assess muscle damage and recovery.

Unit of Measure: Micrograms per liter (µg/L)
From pre-intervention to 48 hours post-intervention.

Collaborators and Investigators

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

Sponsor

University of Castilla-La Mancha

Investigators

  • Principal Investigator: Jose Luis Felipe, PhD, University of Castilla-La Mancha

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

May 1, 2025

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGOID1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We have decided not to share Individual Participant Data (IPD) with other researchers for several reasons:

Participant Privacy and Confidentiality: Protecting participant privacy is paramount. Sharing IPD, even de-identified, risks re-identification and breaches confidentiality.

Ethical Considerations: Our study involves sensitive health and performance data. Limiting access ensures responsible and ethical use, preventing misuse or misinterpretation.

Data Security: Sharing IPD requires robust security measures to prevent unauthorized access and breaches, which are complex and resource-intensive to maintain.

Informed Consent: Our consent process did not include provisions for sharing IPD with external researchers. Sharing data without explicit consent would violate ethical approval and participant trust.

Resource Constraints: Managing data sharing requests and providing necessary support to external researchers require significant resources, which we currently lack.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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