An interventional study of Cold Water Immersion (CWI) and Hot Water Immersion (HWI) in Muscle Soreness, sponsored by Józef Piłsudski University of Physical Education. Recruiting at 1 site in Poland. Open to male participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by Józef Piłsudski University of Physical Education · Not applicable, Interventional, and Treatment
The study investigates the effectiveness of physical strategies in addressing Delayed Onset Muscle Soreness (DOMS) in physically active individuals. DOMS, a common phenomenon following intense or novel physical activity, is characterized by pain, inflammation, and functional impairments such as reduced range of motion, muscle strength, and endurance. These symptoms peak between 24-72 hours post-exercise and are attributed to micro-damage in muscle and connective tissue, followed by inflammatory responses. Despite extensive research, the efficacy of various therapeutic interventions remains inconclusive due to heterogeneity in study designs, outcome measures, and quality of evidence.
The primary objective of this study is to systematically assess and compare the effectiveness of cold water immersion (CWI) or hot water immersion (HWI), in mitigating DOMS symptoms. This study will utilize a multi-arm, parallel, randomized controlled trial (RCT) design to evaluate therapeutic outcomes against a control group receiving simulated therapy.
By employing a standardized exercise protocol to induce DOMS and unified assessment methodologies (e.g., biomechanical, biochemical, and functional tests), the study aims to provide robust evidence for the efficacy of these interventions. The findings will contribute to optimizing post-exercise recovery strategies, offering reliable therapeutic protocols for both clinical and athletic settings.
The study is a multi-arm, parallel, randomized controlled trial (RCT) designed to evaluate the effectiveness of cold water immersion (CWI), warm water immersion (WWI), and simulated laser therapy (control group) in mitigating Delayed Onset Muscle Soreness (DOMS). This trial aims to compare the physiological, biochemical, and functional outcomes of these interventions following exercise-induced muscle damage in healthy male participants. DOMS, which arises from eccentric physical activities, presents with symptoms such as muscle pain, stiffness, inflammation, and functional limitations, reaching a peak 24-72 hours post-exercise.
Setting and Duration The study will be conducted at the laboratories of the Faculty of Physical Education and Health at AWF Biała Podlaska between March and May 2024. The laboratory sessions will take place on weekdays from 8:00 AM to 4:00 PM.
Methodology Participants will be randomly assigned to one of three study groups
Cold Water Immersion (CWI):
Participants will submerge their lower limbs in water maintained at 10-12°C for 15 minutes. The water temperature will be regulated with ice additions to ensure consistency. Participants will perform light movements, such as ankle flexion and extension, to stimulate blood flow.
Sessions will occur 1 hour post-exercise, and at 24 and 48 hours.
Hot Water Immersion (HWI):
Participants will immerse their lower limbs in water at 40°C for 15 minutes, maintaining consistent temperature conditions.
Sessions will follow the same schedule as the CWI group (1, 24, and 48 hours post-exercise).
Simulated Laser Therapy (Control Group):
Participants in this group will receive simulated low-level laser therapy (LLLT). A deactivated laser device will be positioned over the muscles to mimic therapy without delivering actual treatment. Simulated sessions will align with the intervention schedule of the other groups.
Study Procedure
The study comprises three phases:
Baseline Measurements (Phase 1):
Conducted in the morning, fasting, followed by standardized functional and biomechanical tests two hours after a light meal.
Measurements include body composition, joint range of motion, muscle stiffness (elastography), pain assessments (VAS scale), and venous blood sampling to measure baseline biochemical markers.
Exercise-Induced Muscle Damage (Phase 2):
Participants will perform eccentric exercises designed to induce DOMS, targeting the quadriceps muscles. The exercise protocol includes five sets of 20 drop jumps from a 60 cm height with a 5-minute rest between sets.
Experienced physiotherapists will ensure the correct execution of exercise.
Post-Exercise Monitoring and Intervention (Phase 3):
Interventions (CWI, WWI, or simulated LLLT) will be administered within an hour post-exercise and repeated at 24 and 48 hours.
Functional tests and blood sampling will be conducted pre-intervention and at 24, 48, 72, and 96 hours post-exercise to assess recovery dynamics.
256 studies on the registry are indexed under Myalgia; 46 are open to participants now.
This study's planned enrollment of 52 is above the median of 44 across 216 interventional studies indexed under Myalgia.
Browse Myalgia studies →Józef Piłsudski University of Physical Education is the lead sponsor of 34 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants subjected only to standard biomechanical, functional, and blood measurements, without the use of regenerative therapies.
Other: Simulated Laser Therapy
Participants are subjected to a bath in cold water (10-12°C) for 10 minutes with the lower limbs submerged to waist height.
Other: Cold Water Immersion (CWI)
Immersing the whole body in hot (40°C) water.
Other: Hot Water Immersion (HWI)
Standard immersion baths with temperature monitoring and ice supplementation. Lower limbs immersed up to the hip. Water temperature maintained at 10-12°C. Duration: 15 minutes per session. Participants perform active ankle flexion/extension to promote circulation.
Also known as: cryotherapy
Controlled immersion baths. Lower limbs immersed up to the hip. Water temperature maintained at 40°C. Duration: 15 minutes per session.
Deactivated low-level laser therapy (LLLT) device. Applicator positioned over quadriceps muscle belly. Duration: 15 minutes, with no active laser output to simulate treatment conditions.
Change in Muscle Soreness (VAS Score)
Muscle Soreness Measured by the Visual Analog Scale (0-10) Description: The Visual Analog Scale (VAS) ranges from 0 ("no muscle pain") to 10 ("worst possible pain"). Higher scores indicate a worse outcome (greater pain).
Time frame: Baseline to 72 hours post-exercise, with measurements at Day 1 (24 hours), Day 2 (48 hours), and Day 3 (72 hours)
Change in Biochemical Markers of Muscle Damage (Creatine Kinase)
Blood samples will be collected at baseline, 24 h, 48 h, and 72 h post-exercise and analyzed for serum Creatine Kinase (U/L) using standard immunoassay methods.
Time frame: Baseline to 72 hours post-exercise, with measurements at Day 1 (24 hours), Day 2 (48 hours), and Day 3 (72 hours)
Change in Quadriceps Muscle Strength (Nm) measured by Dynamometer at Baseline, 24h, 48h, 72h Post-Exercise
Time frame: Baseline to 72 hours post-exercise, with measurements at Day 1 (24 hours), Day 2 (48 hours), and Day 3 (72 hours)
Change in Quadriceps Muscle Tissue Elasticity (kPa) measured by Ultrasound Elastography at Baseline, 24h, 48h, 72h Post-Exercise
Time frame: Baseline to 72 hours post-exercise, with measurements at Day 1 (24 hours), Day 2 (48 hours), and Day 3 (72 hours)
Baseline to 72 hours post-exercise, with measurements at Day 1 (24 hours), Day 2 (48 hours), and Day 3 (72 hours)
Time frame: Baseline to 72 hours post-exercise, with measurements at Day 1 (24 hours), Day 2 (48 hours), and Day 3 (72 hours)
Change in Biochemical Markers of Muscle Damage: Myoglobin
Blood samples will be collected at baseline, 24 h, 48 h, and 72 h post-exercise and analyzed for Myoglobin (ng/mL), using standard immunoassay methods.
Time frame: Baseline to 72 hours post-exercise, with measurements at Day 1 (24 hours), Day 2 (48 hours), and Day 3 (72 hours)
Change in Inflammation markers (IL-6, TNF-α)
Blood samples will be collected at baseline, 24 h, 48 h, and 72 h post-exercise and analyzed for Interleukin 6 (IL-6) and Tumor Necrosis Factor α (TNF-α) (pg/mL), using standard immunoassay methods.
Time frame: Baseline to 72 hours post-exercise, with measurements at Day 1 (24 hours), Day 2 (48 hours), and Day 3 (72 hours)
Plan to share: No — Because the study sample is small and participants were locally recruited, there is a heightened risk that individual identities could be inferred. Therefore, we do not plan to share de-identified participant data in order to protect privacy and confidentiality.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Józef Piłsudski University of Physical Education