Clinical trial NCT06920966: Recovery Optimization Intervention to Reduce the Risk of Injuries in Soccer Players
Official title: Recovery Optimization Intervention to Reduce the Risk of Injuries in Soccer Players
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Muscle Fatigue Reduction:
timeFrame: From pre-intervention to 48 hours post-intervention
measure: Countermovement Jump (CMJ) test
timeFrame: From pre-intervention to 48 hours post-intervention.
measure: Isometric Strenght Test (Hamstrings)
timeFrame: From pre-intervention to 48 hours post-intervention.
measure: Isometric Strenght Test (Adductor)
timeFrame: From pre-intervention to 48 hours post-intervention.
measure: Squat Performance
timeFrame: From pre-intervention to 48 hours post-intervention.
Secondary outcomes:
measure: Perceived Recovery
timeFrame: At 24 and 48 hours post-intervention.
measure: Stress Levels
timeFrame: At 24 and 48 hours post-intervention.
measure: Fatigue
timeFrame: At 24 and 48 hours post-intervention.
measure: Muscle Soreness
timeFrame: At 24 and 48 hours post-intervention.
measure: Sleep Quality
timeFrame: At 24 and 48 hours post-intervention.
measure: Overall Well-Being
timeFrame: At 24 and 48 hours post-intervention.
measure: Thermographic Assessments
timeFrame: From pre-intervention to 48 hours post-intervention.
Other outcomes:
measure: Injury Risk Assessment
timeFrame: From baseline (enrollment) to 24 weeks post-intervention.
measure: Concentration of 3-Methylhistidine in Urine
timeFrame: From pre-intervention to 48 hours post-intervention.
Locations:
Study officials:
affiliation: University of Castilla-La Mancha
name: Jose Luis Felipe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.