Muscle Fatigue (C23.888.592.612.612)NCT06920966
Recovery Optimization Intervention to Reduce the Risk of Injuries in Soccer Players
A study testing Cold Water Immersion (CWI), Hot water immersion (HWI) and Thermography-Guided Immersion (TI) in people with Muscle Fatigue (C23.888.592.612.612) and Athletic Injuries (C26.857.500.124), run by University of Castilla-La Mancha.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Fatigue (C23.888.592.612.612), Athletic Injuries (C26.857.500.124), Recovery of Function (G11.427.698.620)
- What is being tested?
- Cold Water Immersion (CWI), Hot water immersion (HWI) and Thermography-Guided Immersion (TI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
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)
- Being tested
- Cold Water Immersion (CWI), Hot water immersion (HWI), Thermography-Guided Immersion (TI)
- Keywords
- Muscle Fatigue, Recovery Interventions, Fatigue Reduction, Recovery Optimization, Physical Performance
- Medical subject headings
- Athletic Injuries, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Water Immersion (CWI)Other
Also called Intermittent Cold Water Immersion (11ºC)
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)Other
Also called Continuous hot water immersion (38ºC)
Participants undergo a continuous immersion of 18 minutes in hot water (38°C)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cold Water Immersion (CWI) |
| Hot Water Immersion (HWI) | Experimental | Participants undergo a continuous immersion of 18 minutes in hot water (38°C). Receives: 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. Receives: Other: Thermography-Guided Immersion (TI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From pre-intervention to 48 hours post-intervention
Countermovement Jump (CMJ) test
Assessed using the countermovement jump (CMJ) test (cm)
Measured: From pre-intervention to 48 hours post-intervention.
Isometric Strenght Test (Hamstrings)
Assessed using isometric strength tests for the hamstrings (N)
Measured: From pre-intervention to 48 hours post-intervention.
Isometric Strenght Test (Adductor)
Assessed using isometric strength tests for the adductors (N)
Measured: From pre-intervention to 48 hours post-intervention.
Squat Performance
Assessed using squat performance with 50% body weight (reps)
Measured: From pre-intervention to 48 hours post-intervention.
Secondary outcomes (7)
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.
Measured: At 24 and 48 hours post-intervention.
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.
Measured: At 24 and 48 hours post-intervention.
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.
Measured: At 24 and 48 hours post-intervention.
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.
Measured: At 24 and 48 hours post-intervention.
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.
Measured: At 24 and 48 hours post-intervention.
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.
Measured: At 24 and 48 hours post-intervention.
Thermographic Assessments
Monitoring skin temperature changes using thermography to evaluate the effectiveness of the recovery interventions.
Measured: From pre-intervention to 48 hours post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscle Fatigue (C23.888.592.612.612)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Luis Felipe, PhD, Principal investigator, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920966
- Sponsor's protocol ID
- IGOID1
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 32560317Bestwick-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
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Optimization Intervention to Reduce the Risk of Injuries in Soccer Players
- ClinicalTrials.gov ID
- NCT06920966
- Acronym / sponsor ID
- IGOID1
- 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)
- Keywords
- Muscle Fatigue, Recovery Interventions, Fatigue Reduction, Recovery Optimization, Physical Performance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cold Water Immersion (CWI) | Experimental | 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. |
| Hot Water Immersion (HWI) | Experimental | Other: Hot water immersion (HWI)Participants undergo a continuous immersion of 18 minutes in hot water (38°C). |
| No Immersion (NI) | No intervention | –Participants follow the same protocol structure without any immersion. |
| Thermography-Guided Immersion (TI) | Experimental | 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold Water Immersion (CWI)Also: Intermittent Cold Water Immersion (11ºC)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)Also: Continuous hot water immersion (38ºC)Participants undergo a continuous immersion of 18 minutes in hot water (38°C) | Other | Hot Water Immersion (HWI) |
| 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) |
Primary outcome
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).
Countermovement Jump (CMJ) test
Time frame: From pre-intervention to 48 hours post-intervention.
Assessed using the countermovement jump (CMJ) test (cm)
Isometric Strenght Test (Hamstrings)
Time frame: From pre-intervention to 48 hours post-intervention.
Assessed using isometric strength tests for the hamstrings (N)
Isometric Strenght Test (Adductor)
Time frame: From pre-intervention to 48 hours post-intervention.
Assessed using isometric strength tests for the adductors (N)
Squat Performance
Time frame: From pre-intervention to 48 hours post-intervention.
Assessed using squat performance with 50% body weight (reps)
7 secondary outcomes
Perceived Recovery
Time frame: At 24 and 48 hours post-intervention.
Stress Levels
Time frame: At 24 and 48 hours post-intervention.
Fatigue
Time frame: At 24 and 48 hours post-intervention.
Muscle Soreness
Time frame: At 24 and 48 hours post-intervention.
Sleep Quality
Time frame: At 24 and 48 hours post-intervention.
Overall Well-Being
Time frame: At 24 and 48 hours post-intervention.
Thermographic Assessments
Time frame: From pre-intervention to 48 hours post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Results publication: PubMed 32560317Lorenzo 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.
- Results publication: PubMed 35468639Bestwick-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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jose Luis Felipe, PhD principal investigator
University of Castilla-La Mancha
Questions about this trial
What is this clinical trial studying?
A study testing Cold Water Immersion (CWI), Hot water immersion (HWI) and Thermography-Guided Immersion (TI) in people with Muscle Fatigue (C23.888.592.612.612) and Athletic Injuries (C26.857.500.124), run by University of Castilla-La Mancha.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose Luis Felipe, PhD (+34648885392, joseluis.felipe@uclm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Fatigue Reduction: (time frame: From pre-intervention to 48 hours post-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06920966, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.