Clinical trial NCT06813690: Effects of Immediate and Delayed Repeated Cold Exposure After Physical Exertion
Official title: Effects of Immediate and Delayed Repeated Cold Exposure After Physical Exertion: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Delayed Onset Muscle Soreness (DOMS)
Inflammation
Muscle Pain
Muscle Damage
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
Lead sponsor: University of Applied Sciences and Arts of Southern Switzerland
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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)

Primary outcomes:
measure: Reduction in Muscle Pain (DOMS)
timeFrame: 72 hours
measure: Reduction in Swelling
timeFrame: 72 hours
measure: Inflammatory Marker Levels
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Applied Sciences of Southern Switzerland
name: Ron Clijsen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petrofsky JS, Khowailed IA, Lee H, Berk L, Bains GS, Akerkar S, Shah J, Al-Dabbak F, Laymon MS. Cold Vs. Heat After Exercise-Is There a Clear Winner for Muscle Soreness. J Strength Cond Res. 2015 Nov;29(11):3245-52. doi: 10.1519/JSC.0000000000001127.
citation: Ostrowski J, Purchio A, Beck M, Leisinger J, Tucker M, Hurst S. Examination of Intramuscular and Skin Temperature Decreases Produced by the PowerPlay Intermittent Compression Cryotherapy. J Sport Rehabil. 2018 May 1;27(3):244-248. doi: 10.1123/jsr.2016-0244. Epub 2018 May 10.
citation: Hubbard TJ, Denegar CR. Does Cryotherapy Improve Outcomes With Soft Tissue Injury? J Athl Train. 2004 Sep;39(3):278-279.
citation: Hohenauer E, Taeymans J, Baeyens JP, Clarys P, Clijsen R. The Effect of Post-Exercise Cryotherapy on Recovery Characteristics: A Systematic Review and Meta-Analysis. PLoS One. 2015 Sep 28;10(9):e0139028. doi: 10.1371/journal.pone.0139028. eCollection 2015.
citation: Bleakley C, McDonough S, Gardner E, Baxter GD, Hopkins JT, Davison GW. Cold-water immersion (cryotherapy) for preventing and treating muscle soreness after exercise. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD008262. doi: 10.1002/14651858.CD008262.pub2.