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Muscle SorenessNCT06804564

Cold Vs Warm Water Immersion for DOMS Recovery

A study testing Cold Water Immersion (CWI), Hot Water Immersion (HWI) and Simulated Laser Therapy in people with Muscle Soreness, run by Józef Piłsudski University of Physical Education at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 25 years, men onlyHealthy volunteers can take part
Conditions the study is for
Muscle Soreness
What is being tested?
Cold Water Immersion (CWI), Hot Water Immersion (HWI) and Simulated Laser Therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
1 sitePoland
Study dates
10 Jan 2025to 31 Mar 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 25 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy males aged 18-25 years
  • BMI between 18.5 and 30 kg/m²
  • Experiencing muscle pain (VAS scale) > 5 for muscle soreness within 12 to 30 hours post-exercise
  • Engage in moderate physical activity 2-5 hours/week, according to the International Physical Activity Questionnaire-Short Form (IPAQ-SF).
  • They must voluntarily sign a written informed consent approved by an ethics/bioethics committee after sufficient explanation prior to participating in the study.

Who cannot join

  • Inflammatory diseases within the past 6 months
  • Neurological disorders that affect muscle strength
  • Ongoing use of steroids, analgesics, muscle relaxants, or other medications deemed inappropriate by the researchers, including antispasmodics, antidepressants, antidiarrheals, antibiotics, or thrombolytics
  • Unstable medical condition such as cardiovascular disease, respiratory disease, gastrointestinal disease, hepatobiliary disease, metabolic disease, endocrine disease, kidney disease, urinary tract disease, genetic disorders, or issues related to the nervous system or mental health.
  • Participants who have abused alcohol or drugs in the past year, do not wish to follow the study guidelines, or are deemed inappropriate for the study by the researcher will also be excluded.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Poland1 site, 1 recruiting
  • Akademia Wychowania Fizycznego w Warszawie

    Biała Podlaska, Lublin Voivodeship, 21-500

    Szczepan Wiecha, +48 602349181, szczepan.wiecha@awf.edu.pl

    Recruiting

Other trials in Poland

About this study

Official title: Comparative Effectiveness of Cold and Warm Water Immersion in Mitigating Delayed Onset Muscle Soreness: a Multi-Arm Randomized Controlled Trial

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.

Read the detailed description

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.

Conditions
Muscle Soreness
Being tested
Cold Water Immersion (CWI), Hot Water Immersion (HWI), Simulated Laser Therapy
Medical subject headings
Myalgia

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 cryotherapy

    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.

  • Hot Water Immersion (HWI)Other

    Controlled immersion baths. Lower limbs immersed up to the hip. Water temperature maintained at 40°C. Duration: 15 minutes per session.

  • Simulated Laser TherapyOther

    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.

Study groups in NCT06804564
Study groupRoleWhat they receive
Control groupSham comparatorParticipants subjected only to standard biomechanical, functional, and blood measurements, without the use of regenerative therapies.
Receives: Other: Simulated Laser Therapy
Cold Water Immersion (CWI)ExperimentalParticipants are subjected to a bath in cold water (10-12°C) for 10 minutes with the lower limbs submerged to waist height.
Receives: Other: Cold Water Immersion (CWI)
Hot Water Therapy (HOT)ExperimentalImmersing the whole body in hot (40°C) water.
Receives: Other: Hot Water Immersion (HWI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline to 72 hours post-exercise, with measurements at Day 1 (24 hours), Day 2 (48 hours), and Day 3 (72 hours)

Secondary outcomes (6)
  1. 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.

    Measured: Baseline to 72 hours post-exercise, with measurements at Day 1 (24 hours), Day 2 (48 hours), and Day 3 (72 hours)

  2. Change in Quadriceps Muscle Strength (Nm) measured by Dynamometer at Baseline, 24h, 48h, 72h Post-Exercise

    Measured: Baseline to 72 hours post-exercise, with measurements at Day 1 (24 hours), Day 2 (48 hours), and Day 3 (72 hours)

  3. Change in Quadriceps Muscle Tissue Elasticity (kPa) measured by Ultrasound Elastography at Baseline, 24h, 48h, 72h Post-Exercise

    Measured: Baseline to 72 hours post-exercise, with measurements at Day 1 (24 hours), Day 2 (48 hours), and Day 3 (72 hours)

  4. Baseline to 72 hours post-exercise, with measurements at Day 1 (24 hours), Day 2 (48 hours), and Day 3 (72 hours)

    Measured: Baseline to 72 hours post-exercise, with measurements at Day 1 (24 hours), Day 2 (48 hours), and Day 3 (72 hours)

  5. 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.

    Measured: Baseline to 72 hours post-exercise, with measurements at Day 1 (24 hours), Day 2 (48 hours), and Day 3 (72 hours)

  6. 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.

    Measured: Baseline to 72 hours post-exercise, with measurements at Day 1 (24 hours), Day 2 (48 hours), and Day 3 (72 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2025
  2. Study start10 Jan 2025
  3. Primary completion28 Feb 2025 (estimated)
  4. Study completion31 Mar 2025 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06804564
Sponsor's protocol ID
SKE 01-80/2023
Status last verified
Dec 2024
First submitted
20 Jan 2025
Last updated
11 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing Cold Water Immersion (CWI), Hot Water Immersion (HWI) and Simulated Laser Therapy in people with Muscle Soreness, run by Józef Piłsudski University of Physical Education at 1 site in Poland.

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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Szczepan Wiecha (+48602349181, szczepan.wiecha@sportslab.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Muscle Soreness (VAS Score) (time frame: Baseline to 72 hours post-exercise, with measurements at Day 1 (24 hours), Day 2 (48 hours), and Day 3 (72 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 11 Feb 2025.

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