Effects of Immediate and Delayed Repeated Cold Exposure After Physical Exertion

Not Applicable

Recruiting

• Conditions: Delayed Onset Muscle Soreness (DOMS); Inflammation; Muscle Pain; Muscle Damage

• Registration Number: NCT06813690
• Lead Sponsor: University of Applied Sciences and Arts of Southern Switzerland

Brief Summary

The goal of this clinical trial is to learn if applying cold therapy can reduce swelling, inflammation, and pain after physical activity in adults who experience muscle soreness (Delayed Onset Muscle Soreness, or DOMS). The main questions it aims to answer are:

* Can cold therapy reduce swelling and inflammation in muscles after exercise?

* Does cold therapy reduce muscle pain and discomfort (DOMS)?

Researchers will compare participants using the Axanova Cold Hot Pearls Maxi Pack to those not receiving any cold therapy to see if the cold application improves recovery outcomes.

Participants will:

* Perform physical activity designed to induce muscle soreness.

* Use the Axanova Cold Hot Pearls Maxi Pack on the affected area as directed.

* Report their level of muscle pain, stiffness, and swelling over the following 72 hours.

The study aims to provide new insights into the effectiveness of cold therapy for muscle recovery, focusing on pain relief, reduced swelling, and improved recovery time.

Detailed Description

Physical activity is influenced by factors such as the type, duration, and intensity. Depending on the extent of these factors and the associated recovery time, muscle damage, inflammation, and fatigue symptoms in the nervous system can occur. Additionally, energy substrate depletion and localized swelling may take place. Therefore, rapid recovery after intense exercise has become increasingly important. According to the meta-analysis by Bleakley et al. (2012), cold therapy is considered one of the most effective recovery methods after physical activity to delay Delayed Onset Muscle Soreness (DOMS).

DOMS consists of microscopic tears in muscle tissue, referred to as exercise-induced muscle damage, which can lead to delayed muscle soreness. DOMS typically peaks between 24 and 48 hours-sometimes up to 72 hours-after exercise and is characterized by muscle shortening, increased passive stiffness, swelling, reduced strength and performance, localized muscle soreness, and altered proprioception.

The physiological basis of cryotherapy lies in the removal of body heat through a reduction in tissue temperature. This results in decreased muscle pain perception, making the body feel more "awake" after training and reducing the sensation of fatigue. Additionally, cold exposure lowers heart rate and cardiac output while inducing vasoconstriction. The outcomes include smaller blood vessel diameters, reduced occurrence of edema, and improved oxygen supply to the cells. To maintain core body temperature, the central metabolism also increases, promoting the transport of metabolic waste products.

All these effects, in combination, may help reduce exercise-induced inflammation by minimizing the death or damage of hypoxic cells and reducing secondary tissue damage through decreased infiltration of leukocytes and monocytes (Bleakley et al. 2012, Hohenauer et al. 2015, Hubbard et al. 2004, Ostrowski et al. 2018).

Study Timeline

• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-02-06
• Study First Posted: 2025-02-07
• Study Start: 2025-03-17
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-30
• Last Update Posted: 2025-08-03
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in Muscle Pain (DOMS)	72 hours	Assessed using a visual analog scale (VAS) to measure self-reported muscle soreness in the thighs over 72 hours.
Reduction in Swelling	72 hours	Swelling of the anterior thigh muscles will be assessed using ultrasound diagnostics. A cross-sectional image of the thigh muscles will be captured, and the distance from the femur to the outer boundary of the muscle will be measured.
Inflammatory Marker Levels	72 hours	Blood samples will be taken in order for markers such as C-reactive protein (CRP) and creatine kinase (CK) levels to be analyzed.

Trial Locations

Locations (1)

University of Applied Sciences and Arts of Southern Switzerland (SUPSI); 🇨🇭 Landquart, Switzerland