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Effects of Immediate and Delayed Repeated Cold Exposure After Physical Exertion

Effects of Immediate and Delayed Repeated Cold Exposure After Physical Exertion: a Randomised Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06813690
Enrollment
48
Registered
2025-02-07
Start date
2025-03-17
Completion date
2025-10-16
Last updated
2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delayed Onset Muscle Soreness (DOMS), Inflammation, Muscle Damage, Muscle Pain

Keywords

Cold therapy for muscle recovery, Delayed Onset Muscle Soreness, Post-exercise recovery methods, Muscle pain and swelling reduction, Inflammation and recovery after exercise, Reducing exercise-induced muscle damage, Clinical trial on cryotherapy effectiveness

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).

Interventions

DEVICECold Therapy with Axanova Cold Hot Pearls Maxi Pack

This intervention involves the application of the Axanova Cold Hot Pearls Maxi Pack, a cooling device designed to provide targeted cold therapy. The device will be used to cool both thighs for 20-minute sessions, three times per day, following a muscle soreness protocol. The cold therapy aims to reduce inflammation, swelling, and muscle pain associated with Delayed Onset Muscle Soreness (DOMS). The intervention begins immediately after completing the muscle soreness protocol in Group A, and 24 hours later in Group B. Participants will receive cooling treatment for a total of 72 hours, with temperature and duration carefully monitored to ensure effective cooling.

Sponsors

University of Applied Sciences and Arts of Southern Switzerland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Reduction in Muscle Pain (DOMS)72 hoursAssessed using a visual analog scale (VAS) to measure self-reported muscle soreness in the thighs over 72 hours.
Reduction in Swelling72 hoursSwelling 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 Levels72 hoursBlood samples will be taken in order for markers such as C-reactive protein (CRP) and creatine kinase (CK) levels to be analyzed.

Countries

Switzerland

Contacts

PRINCIPAL_INVESTIGATORRon Clijsen, Prof. Dr.

University of Applied Sciences of Southern Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026