ClinicalTrials.gg
CompletedNCT06813690Updated Mar 4, 2026

Effects of Immediate and Delayed Repeated Cold Exposure After Physical Exertion

An interventional study of Cold Therapy with Axanova Cold Hot Pearls Maxi Pack in Delayed Onset Muscle Soreness (DOMS), Inflammation and Muscle Pain, sponsored by University of Applied Sciences and Arts of Southern Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-04.

Primary conditionMyalgiaRegistry: InflammationReclassifiedWhy we changed it
Registry
Inflammation — the first condition term the registry derived for this study.
ClinicalTrials.gg
Myalgia
Why
  1. Inflammation is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Myalgia.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Applied Sciences and Arts of Southern Switzerland · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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.

Read the 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).

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Conditions studied

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

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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
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In context

Myalgia Reclassified

256 studies on the registry are indexed under Myalgia; 46 are open to participants now.

This study's enrollment of 48 is close to the median of 44 across 216 interventional studies indexed under Myalgia.

Browse Myalgia studies →

Lead sponsor

University of Applied Sciences and Arts of Southern Switzerland is the lead sponsor of 13 studies on the registry; none are open to participants now.

Compared within Myalgia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Inflammation. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria

  • Current pain conditions
  • Current inflammatory conditions
  • Medication use (excluding )
  • Pregnant participants
  • Competitive athletes
  • Children/teenagers
  • Non-intact skin conditions (e.g., psoriasis)
  • Known circulatory disorders
  • Cold allergy (Raynaud's disease)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Group A: Immediate Cooling

    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.

    Device: Cold Therapy with Axanova Cold Hot Pearls Maxi Pack

  • Experimental
    Group B: Delayed Cooling

    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.

    Device: Cold Therapy with Axanova Cold Hot Pearls Maxi Pack

  • No intervention
    Group C: Control Group

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

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.

06

What researchers measure

Primary outcomes

  1. Reduction in Muscle Pain (DOMS)

    Assessed using a visual analog scale (VAS) to measure self-reported muscle soreness in the thighs over 72 hours.

    Time frame: 72 hours

  2. Reduction in Swelling

    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.

    Time frame: 72 hours

  3. Inflammatory Marker Levels

    Blood samples will be taken in order for markers such as C-reactive protein (CRP) and creatine kinase (CK) levels to be analyzed.

    Time frame: 72 hours

07

Study locations

1 site
  • University of Applied Sciences and Arts of Southern Switzerland (SUPSI)
    Landquart, 7302, Switzerland
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References and documents

Publications

  • 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. PubMed 26502272 ↗
  • 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. PubMed 28422604 ↗
  • Hubbard TJ, Denegar CR. Does Cryotherapy Improve Outcomes With Soft Tissue Injury? J Athl Train. 2004 Sep;39(3):278-279. PubMed 15496998 ↗
  • 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. PubMed 26413718 ↗
  • 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. PubMed 22336838 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06813690
Lead sponsor
University of Applied Sciences and Arts of Southern Switzerland
Responsible party
Ron Clijsen (Prof. Dr., University of Applied Sciences and Arts of Southern Switzerland) — Principal investigator
First posted
Feb 7, 2025
Start date
Mar 17, 2025
Primary completion
Oct 16, 2025
Completion
Oct 16, 2025
Last update
Mar 4, 2026

Study contacts

Ron Clijsen, Prof. Dr.
principal investigator · University of Applied Sciences of Southern Switzerland

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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