Effects of Immediate and Delayed Repeated Cold Exposure After Physical Exertion

NCT06813690 | Completed DMC

• 1 other identifier: 2024-D0116
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Reduction in Muscle Pain (DOMS)

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

  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.

  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.

  72 hours

Study Arms (3)

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.

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.

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.

Interventions

Cold Therapy with Axanova Cold Hot Pearls Maxi Pack DEVICE

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.

Group A: Immediate Cooling; Group B: Delayed Cooling

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Young, healthy adults aged between 18 and 30 years
• No surgical interventions on the musculoskeletal system in the trunk area or lower extremities

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Applied Sciences and Arts of Southern Switzerland: lead

Study Sites (1)

University of Applied Sciences and Arts of Southern Switzerland (SUPSI)

Landquart, 7302, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 26502272 BACKGROUND

• 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.

  PMID: 28422604 BACKGROUND

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

  PMID: 15496998 BACKGROUND

• 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.

  PMID: 26413718 BACKGROUND

• 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.

  PMID: 22336838 BACKGROUND

MeSH Terms

Conditions

Inflammation; Myalgia

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Ron Clijsen, Prof. Dr.

  University of Applied Sciences of Southern Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: February 7, 2025
• Study Start: March 17, 2025
• Primary Completion: October 16, 2025
• Study Completion: October 16, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

CH (1)