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

NCT ID: NCT06920966

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2025-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Muscle Fatigue (C23.888.592.612.612) Athletic Injuries (C26.857.500.124) Recovery of Function (G11.427.698.620) Cryotherapy (E02.095.301.250) Thermotherapy (E02.095.301.750) Soccer (I03.450.642.845.750) Biomarkers (D23.050.301) Thermography (E01.370.350.700.750) Physical Fitness (G11.427.410.698)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This study employs a randomized crossover design to evaluate the effects of different recovery interventions on reducing muscle fatigue and improving performance in football players. The interventions include cold water immersion (CWI), hot water immersion (HWI), no immersion (NI), and thermography-guided immersion (TI).

Participants are randomly assigned to different intervention sequences, ensuring each participant receives all interventions in a random order. The study is divided into four blocks, each lasting five weeks. During each block, participants undergo one of the recovery interventions.

Interventions:

CWI: Five intermittent immersions of 2 minutes each in cold water (11°C). HWI: Continuous immersion of 18 minutes in hot water (38°C). NI: No immersion. TI: Based on thermographic assessments, participants receive either CWI or HWI. Outcome measures include muscle fatigue, performance metrics, biomarker levels, and subjective recovery assessments.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

We selected "None (Open Label)" for masking in this study for several reasons:

Practicality and Feasibility: The interventions (cold and hot water immersions) are easily distinguishable by participants due to their distinct physical sensations, making blinding impractical.

Transparency and Compliance: An open-label design allows full transparency with participants, enhancing compliance and cooperation as they understand the procedures and potential benefits.

Ethical Considerations: Providing complete information respects participants' autonomy and their right to make informed decisions about their participation, especially for physical interventions affecting their health.

Data Collection and Monitoring: The open-label design facilitates easier monitoring and data collection, improving accuracy and reliability without the need for complex blinding procedures.

Focus on Objective Measures: The study relies on objective measures (thermography, biomarker analysis, performance tests)

Study Groups

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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.

Group Type EXPERIMENTAL

Cold Water Immersion (CWI)

Intervention Type OTHER

Participants undergo five intermittent immersions of 2 minutes each in cold water (11°C), with 2-minute rest periods in between.

Hot Water Immersion (HWI)

Participants undergo a continuous immersion of 18 minutes in hot water (38°C).

Group Type EXPERIMENTAL

Hot water immersion (HWI)

Intervention Type OTHER

Participants undergo a continuous immersion of 18 minutes in hot water (38°C)

No Immersion (NI)

Participants follow the same protocol structure without any immersion.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Thermography-Guided Immersion (TI)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Hot water immersion (HWI)

Participants undergo a continuous immersion of 18 minutes in hot water (38°C)

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Intermittent Cold Water Immersion (11ºC) Continuous hot water immersion (38ºC)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Castilla-La Mancha

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jose Luis Felipe, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Castilla-La Mancha

Central Contacts

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Jose Luis Felipe, PhD

Role: CONTACT

+34648885392

Antonio Alonso, MsC

Role: CONTACT

+34 615 45 09 89

References

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Lorenzo Calvo J, Alorda-Capo F, Pareja-Galeano H, Jimenez SL. Influence of Nitrate Supplementation on Endurance Cyclic Sports Performance: A Systematic Review. Nutrients. 2020 Jun 17;12(6):1796. doi: 10.3390/nu12061796.

Reference Type BACKGROUND
PMID: 32560317 (View on PubMed)

Bestwick-Stevenson T, Toone R, Neupert E, Edwards K, Kluzek S. Assessment of Fatigue and Recovery in Sport: Narrative Review. Int J Sports Med. 2022 Dec;43(14):1151-1162. doi: 10.1055/a-1834-7177. Epub 2022 Apr 25.

Reference Type BACKGROUND
PMID: 35468639 (View on PubMed)

Other Identifiers

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IGOID1

Identifier Type: -

Identifier Source: org_study_id

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