ClinicalTrials.gg
Not yet recruitingNCT06920966Updated Apr 10, 2025

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

An interventional study of Cold Water Immersion (CWI) and Hot water immersion (HWI) in Muscle Fatigue (C23.888.592.612.612), Athletic Injuries (C26.857.500.124) and Recovery of Function (G11.427.698.620), sponsored by University of Castilla-La Mancha. Not yet recruiting. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-10.

Sponsored by University of Castilla-La Mancha · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Athletic Injuries

258 studies on the registry are indexed under Athletic Injuries; 45 are open to participants now.

This study's planned enrollment of 25 is below the median of 44 across 164 interventional studies indexed under Athletic Injuries.

Browse Athletic Injuries studies →

Lead sponsor

University of Castilla-La Mancha is the lead sponsor of 107 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • 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)

  • Experimental
    Hot Water Immersion (HWI)

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

    Other: Hot water immersion (HWI)

  • 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)

Interventions

  • OtherCold Water Immersion (CWI)

    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)

  • OtherHot water immersion (HWI)

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

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

  • OtherThermography-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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: From pre-intervention to 48 hours post-intervention

  2. Countermovement Jump (CMJ) test

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

    Time frame: From pre-intervention to 48 hours post-intervention.

  3. Isometric Strenght Test (Hamstrings)

    Assessed using isometric strength tests for the hamstrings (N)

    Time frame: From pre-intervention to 48 hours post-intervention.

  4. Isometric Strenght Test (Adductor)

    Assessed using isometric strength tests for the adductors (N)

    Time frame: From pre-intervention to 48 hours post-intervention.

  5. Squat Performance

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

    Time frame: From pre-intervention to 48 hours post-intervention.

Secondary outcomes

  1. Perceived Recovery

    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.

    Time frame: At 24 and 48 hours post-intervention.

  2. Stress Levels

    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.

    Time frame: At 24 and 48 hours post-intervention.

  3. Fatigue

    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.

    Time frame: At 24 and 48 hours post-intervention.

  4. Muscle Soreness

    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.

    Time frame: At 24 and 48 hours post-intervention.

  5. Sleep Quality

    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.

    Time frame: At 24 and 48 hours post-intervention.

  6. Overall Well-Being

    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.

    Time frame: At 24 and 48 hours post-intervention.

  7. Thermographic Assessments

    Monitoring skin temperature changes using thermography to evaluate the effectiveness of the recovery interventions.

    Time frame: From pre-intervention to 48 hours post-intervention.

Other outcomes

  1. Injury Risk Assessment

    Examining the association between recovery interventions and injury risk, based on the incidence of injuries recorded during the study period.

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

  2. Concentration of 3-Methylhistidine in Urine

    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)

    Time frame: From pre-intervention to 48 hours post-intervention.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 32560317 ↗
  • 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. PubMed 35468639 ↗

Individual participant data

Plan to share: No — 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2025; primary completion for Jun 2025, 1 month later.

Of 119 non-industry interventional studies with no phase under Athletic Injuries, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 14. This study's planned 1 month is below that.

Counting every sponsor, half of 121 studies reached it within 5 months; a quarter within 2 and three quarters within 14.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2025
First posted
Apr 10, 2025
StartEst.
May 1, 2025
Primary completionEst.
Jun 1, 2025
CompletionEst.
Sep 1, 2025
Last update
Apr 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06920966
Responsible party
Sponsor
First posted
Apr 10, 2025
Start date
May 1, 2025 (estimated)
Primary completion
Jun 1, 2025 (estimated)
Completion
Sep 1, 2025 (estimated)
Last update
Apr 10, 2025

Study contacts

Jose Luis Felipe, PhD
Contact
joseluis.felipe@uclm.es
+34648885392
Antonio Alonso, MsC
Contact
antonio.alonso@uclm.es
+34 615 45 09 89
Jose Luis Felipe, PhD
principal investigator · University of Castilla-La Mancha

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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