Effects of Immediate and Delayed Repeated Cold Exposure After Physical Exertion

March 3, 2026 updated by: Ron Clijsen, University of Applied Sciences and Arts of Southern Switzerland

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)?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Landquart, Switzerland, 7302
        • University of Applied Sciences and Arts of Southern Switzerland (SUPSI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
72 hours
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.
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Applied Sciences and Arts of Southern Switzerland

Investigators

  • Principal Investigator: Ron Clijsen, Prof. Dr., University of Applied Sciences of Southern Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2025

Primary Completion (Actual)

October 16, 2025

Study Completion (Actual)

October 16, 2025

Study Registration Dates

First Submitted

January 20, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

February 7, 2025

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-D0116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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