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

NCT06920966 | Not Yet Recruiting

• 1 other identifier: IGOID1
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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)

Keywords

Muscle Fatigue; Recovery Interventions; Fatigue Reduction; Recovery Optimization; Physical Performance

Outcome Measures

Primary Outcomes (5)

• Muscle Fatigue Reduction:

  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

  Assessed using the countermovement jump (CMJ) test (cm)

  From pre-intervention to 48 hours post-intervention.

• Isometric Strenght Test (Hamstrings)

  Assessed using isometric strength tests for the hamstrings (N)

  From pre-intervention to 48 hours post-intervention.

• Isometric Strenght Test (Adductor)

  Assessed using isometric strength tests for the adductors (N)

  From pre-intervention to 48 hours post-intervention.

• Squat Performance

  Assessed using squat performance with 50% body weight (reps)

  From pre-intervention to 48 hours post-intervention.

Secondary Outcomes (7)

• Perceived Recovery

  At 24 and 48 hours post-intervention.

• Stress Levels

  At 24 and 48 hours post-intervention.

• Fatigue

  At 24 and 48 hours post-intervention.

• Muscle Soreness

  At 24 and 48 hours post-intervention.

• Sleep Quality

  At 24 and 48 hours post-intervention.

Other Outcomes (2)

• Injury Risk Assessment

  From baseline (enrollment) to 24 weeks post-intervention.

• Concentration of 3-Methylhistidine in Urine

  From pre-intervention to 48 hours post-intervention.

Study Arms (4)

Cold Water Immersion (CWI)

EXPERIMENTAL

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)

Hot Water Immersion (HWI)

EXPERIMENTAL

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

Other: Hot water immersion (HWI)

No Immersion (NI)

NO INTERVENTION

Participants follow the same protocol structure without any immersion.

Thermography-Guided Immersion (TI)

EXPERIMENTAL

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)

Interventions

Cold Water Immersion (CWI) OTHER

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

Also known as: Intermittent Cold Water Immersion (11ºC)

Cold Water Immersion (CWI)

Hot water immersion (HWI) OTHER

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

Also known as: Continuous hot water immersion (38ºC)

Hot Water Immersion (HWI)

Thermography-Guided Immersion (TI) 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.

Thermography-Guided Immersion (TI)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Related Publications (2)

• 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.

  PMID: 32560317 BACKGROUND

• 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.

  PMID: 35468639 BACKGROUND

MeSH Terms

Conditions

Athletic Injuries; Hyperthermia

Condition Hierarchy (Ancestors)

Wounds and Injuries; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders

Study Officials

• Jose Luis Felipe, PhD

  University of Castilla-La Mancha

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Luis Felipe, PhD

CONTACT

+34648885392; joseluis.felipe@uclm.es

Antonio Alonso, MsC

CONTACT

+34 615 45 09 89; antonio.alonso@uclm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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)
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 10, 2025
• Study Start: May 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share