Effects of Immediate and Delayed Repeated Cold Exposure After Physical Exertion

University of Applied Sciences and Arts of Southern Switzerland

Status: Enrolling

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

Treatments: Device: Cold Therapy with Axanova Cold Hot Pearls Maxi Pack

Study type: Interventional

Funder types: Other

Identifiers

NCT06813690

2024-D0116

Details and patient eligibility

About

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.

Full 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).

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Young, healthy adults aged between 18 and 30 years
• No surgical interventions on the musculoskeletal system in the trunk area or lower extremities

Exclusion Criteria

• Current pain conditions
• Current inflammatory conditions
• Medication use (excluding contraceptives)
• Pregnant participants
• Competitive athletes
• Children/teenagers
• Non-intact skin conditions (e.g., psoriasis)
• Known circulatory disorders
• Cold allergy (Raynaud's disease)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Group A: Immediate Cooling

Experimental group

Description:

In this group, cooling begins immediately after completing the muscle soreness protocol. Cooling is performed three times per day on the day of the protocol and continues for 72 hours. Both thighs are cooled using the "Cold Hot Maxi Pack" from Axanova for 20 minutes per session.

Treatment:

Device: Cold Therapy with Axanova Cold Hot Pearls Maxi Pack

Group B: Delayed Cooling

Experimental group

Description:

In this group, cooling begins 24 hours after completing the muscle soreness protocol. Cooling is also performed three times per day for 72 hours. Both thighs are cooled using the "Cold Hot Maxi Pack" from Axanova for 20 minutes per session.

Treatment:

Device: Cold Therapy with Axanova Cold Hot Pearls Maxi Pack

Group C: Control Group

No Intervention group

Description:

This group receives no cooling intervention or any other intervention after the muscle soreness protocol and throughout the study period.