Delayed Onset Muscle Soreness (DOMS)NCT06813690
Effects of Immediate and Delayed Repeated Cold Exposure After Physical Exertion
A study testing Cold Therapy with Axanova Cold Hot Pearls Maxi Pack in people with Delayed Onset Muscle Soreness (DOMS) and Inflammation, run by University of Applied Sciences and Arts of Southern Switzerland at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Delayed Onset Muscle Soreness (DOMS), Inflammation, Muscle Pain
- What is being tested?
- Cold Therapy with Axanova Cold Hot Pearls Maxi Pack
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Mar 2025to 16 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young, healthy adults aged between 18 and 30 years
- No surgical interventions on the musculoskeletal system in the trunk area or lower extremities
Who cannot join
- Current pain conditions
- Current inflammatory conditions
- Medication use (excluding contraceptives)
- Pregnant participants
- Competitive athletes
- Children/teenagers
Show all 9Show fewer
- Non-intact skin conditions (e.g., psoriasis)
- Known circulatory disorders
- Cold allergy (Raynaud's disease)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Applied Sciences and Arts of Southern Switzerland (SUPSI)
Landquart, 7302
About this study
Official title: Effects of Immediate and Delayed Repeated Cold Exposure After Physical Exertion: a Randomised Controlled Trial
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)?
Read more
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).
- Being tested
- Cold Therapy with Axanova Cold Hot Pearls Maxi Pack
- 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
- Medical subject headings
- Inflammation, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Therapy with Axanova Cold Hot Pearls Maxi PackDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Immediate Cooling | Experimental | 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. Receives: Device: Cold Therapy with Axanova Cold Hot Pearls Maxi Pack |
| Group B: Delayed Cooling | Experimental | 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. Receives: Device: Cold Therapy with Axanova Cold Hot Pearls Maxi Pack |
| Group C: Control Group | No intervention | This group receives no cooling intervention or any other intervention after the muscle soreness protocol and throughout the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Muscle Pain (DOMS)
Assessed using a visual analog scale (VAS) to measure self-reported muscle soreness in the thighs over 72 hours.
Measured: 72 hours
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.
Measured: 72 hours
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.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start17 Mar 2025
- Primary completion16 Oct 2025
- Study completion16 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Delayed Onset Muscle Soreness (DOMS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Applied Sciences and Arts of Southern Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ron Clijsen, University of Applied Sciences and Arts of Southern Switzerland
- Investigators
- Ron Clijsen, Prof. Dr., Principal investigator, University of Applied Sciences of Southern Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813690
- Sponsor's protocol ID
- 2024-D0116
- Status last verified
- Mar 2026
- First submitted
- 20 Jan 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 26502272Ostrowski 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 28422604Hubbard TJ, Denegar CR. Does Cryotherapy Improve Outcomes With Soft Tissue Injury? J Athl Train. 2004 Sep;39(3):278-279.
PubMed 15496998Hohenauer 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 26413718Bleakley 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 22336838Buehler C, Romitti R, Wellauer V, Clijsen R, Hohenauer E. Effects of Immediate and Delayed Repeated Cold Exposure After Physical Exertion: A Randomized Controlled Trial. Int J Environ Res Public Health. 2026 Jul 9;23(7):887. doi: 10.3390/ijerph23070887.
PubMed 42512191
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Immediate and Delayed Repeated Cold Exposure After Physical Exertion: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06813690
- Acronym / sponsor ID
- 2024-D0116
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Applied Sciences and Arts of Southern SwitzerlandUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 16 Oct 2025 (actual)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Immediate Cooling | Experimental | Device: Cold Therapy with Axanova Cold Hot Pearls Maxi PackIn 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. |
| Group B: Delayed Cooling | Experimental | Device: Cold Therapy with Axanova Cold Hot Pearls Maxi PackIn 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. |
| Group C: Control Group | No intervention | –This group receives no cooling intervention or any other intervention after the muscle soreness protocol and throughout the study period. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Young, healthy adults aged between 18 and 30 years
- No surgical interventions on the musculoskeletal system in the trunk area or lower extremities
Key exclusion criteria (9 listed)
- Current pain conditions
- Current inflammatory conditions
- Medication use (excluding contraceptives)
- Pregnant participants
- Competitive athletes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold Therapy with Axanova Cold Hot Pearls Maxi PackThis 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. | Device | Group A: Immediate Cooling, Group B: Delayed Cooling |
Primary outcome
Reduction in Muscle Pain (DOMS)
Time frame: 72 hours
Assessed using a visual analog scale (VAS) to measure self-reported muscle soreness in the thighs over 72 hours.
Reduction in Swelling
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Background: PubMed 26502272Petrofsky 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.
- Background: PubMed 28422604Ostrowski 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.
- Background: PubMed 15496998Hubbard TJ, Denegar CR. Does Cryotherapy Improve Outcomes With Soft Tissue Injury? J Athl Train. 2004 Sep;39(3):278-279.
- Background: PubMed 26413718Hohenauer 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.
- Background: PubMed 22336838Bleakley 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.
- Derived from this study: PubMed 42512191Buehler C, Romitti R, Wellauer V, Clijsen R, Hohenauer E. Effects of Immediate and Delayed Repeated Cold Exposure After Physical Exertion: A Randomized Controlled Trial. Int J Environ Res Public Health. 2026 Jul 9;23(7):887. doi: 10.3390/ijerph23070887.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Clijsen, Prof. Dr. principal investigator
University of Applied Sciences of Southern Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Therapy with Axanova Cold Hot Pearls Maxi Pack in people with Delayed Onset Muscle Soreness (DOMS) and Inflammation, run by University of Applied Sciences and Arts of Southern Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Muscle Pain (DOMS) (time frame: 72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06813690, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.