Cold Vs Warm Water Immersion for DOMS Recovery

NCT06804564 | Recruiting

• 1 other identifier: SKE 01-80/2023
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Muscle Soreness

Outcome Measures

Primary Outcomes (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).

  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)

• Change in Biochemical Markers of Muscle Damage (Creatine Kinase)

  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

  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

  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)

  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

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

Study Arms (3)

Control group

SHAM COMPARATOR

Participants subjected only to standard biomechanical, functional, and blood measurements, without the use of regenerative therapies.

Other: Simulated Laser Therapy

Cold Water Immersion (CWI)

EXPERIMENTAL

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)

Hot Water Therapy (HOT)

EXPERIMENTAL

Immersing the whole body in hot (40°C) water.

Other: Hot Water Immersion (HWI)

Interventions

Cold Water Immersion (CWI) OTHER

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

Cold Water Immersion (CWI)

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.

Hot Water Therapy (HOT)

Simulated Laser Therapy OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Józef Piłsudski University of Physical Education: lead

Study Sites (1)

Akademia Wychowania Fizycznego w Warszawie

Biała Podlaska, Lublin Voivodeship, 21-500, Poland

RECRUITING

MeSH Terms

Conditions

Myalgia

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Szczepan Wiecha

CONTACT

+48602349181; szczepan.wiecha@sportslab.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: February 3, 2025
• Study Start: January 10, 2025
• Primary Completion: February 28, 2025
• Study Completion: March 31, 2025
• Last Updated: February 11, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)