About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Cold Water Immersion (CWI)
Other interventionStandard 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 interventionControlled immersion baths. Lower limbs immersed up to the hip. Water temperature maintained at 40°C. Duration: 15 minutes per session.
Simulated Laser Therapy
Other interventionDeactivated low-level laser therapy (LLLT) device. Applicator positioned over quadriceps muscle belly. Duration: 15 minutes, with no active laser output to simulate treatment conditions.
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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.
Change in Quadriceps Muscle Strength (Nm) measured by Dynamometer at Baseline, 24h, 48h, 72h Post-Exercise
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)
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