NCT05506514

Brief Summary

The use of cold on muscle (Ice, Cold Water Immersion - CWI or cryotherapy) is a widespread practice used by health professionals, athletes or non-athletic population in the treatment of muscle soreness and soft tissue injuries. Application of cold on muscle is well known to decrease inflammation and reduce pain perception. However, some studies in humans and animals have reported contrasted effects of cold on muscle regeneration. On the other hand, recent studies in humans suggest that passive heat exposure can impact positively muscle protein synthesis, mitochondrial content and muscle torque in different types of populations. Rodent studies comparing heat and cold modalities following a muscle injury have reported that only repeated heat exposure enhances cross sectional area, accelerate macrophage infiltration in damaged fibers and enhances satellite cells activation which led to a faster muscle regeneration. As such heat therapy may be a promising tool to accelerate recovery after muscle injury. This study will investigate the effect of three distinct thermal interventions (Hot, Cold and Thermoneutral water immersion) on human skeletal muscle regeneration after an eccentric exercise. 36 participants will be distributed in a counterbalanced way into 3 groups being immersed for 15min to 1h per day in either HEAT or COLD or NEUTRAL water for 10 days following eccentric contractions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

July 14, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2024

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

1.8 years

First QC Date

April 24, 2022

Last Update Submit

June 12, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in muscle strength after 2 days

    Change in maximal knee extensor isometric voluntary force (kg) 2 days after the exercise as compared to baseline

    2 days post exercise

  • Change in muscle strength after 4 days

    Change in maximal knee extensor isometric voluntary force (kg) 4 days after the exercise as compared to baseline

    4 days post exercise

  • Change in muscle strength after 10 days

    Change in maximal knee extensor isometric voluntary force (kg) 10 days after the exercise as compared to baseline

    10 days post exercise

Secondary Outcomes (2)

  • Change in muscle fiber

    5 days post exercise

  • Change in muscle fiber

    11 days post exercise

Study Arms (3)

Hot

EXPERIMENTAL

1h per day of water immersion at 42ºC for 11 days

Other: Water immersion

Temperate

SHAM COMPARATOR

30min per day of water immersion at 32ºC for 11 days

Other: Water immersion

Cold

EXPERIMENTAL

15min per day of water immersion at 15ºC for 11 days

Other: Water immersion

Interventions

Comparison of 3 different water temperatures

ColdHotTemperate

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Adult (18 to 45 yrs)
  • Physically active

You may not qualify if:

  • Contraindication to physical activity as per the Par-Q questionnaire
  • Neural, skin or muscular pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aspetar sport medicine hospital

Doha, Baladīyat ad Dawḩah, 0000, Qatar

Location

Related Publications (1)

  • Dablainville V, Mornas A, Normand-Gravier T, Al-Mulla M, Papakostas E, Olory B, Fermin TM, Zampeli F, Nader N, Alhammoud M, Bayne F, Sanchez AMJ, Cardinale M, Candau R, Bernardi H, Racinais S. Muscle regeneration is improved by hot water immersion but unchanged by cold following a simulated musculoskeletal injury in humans. J Physiol. 2025 Dec;603(23):7603-7625. doi: 10.1113/JP287777. Epub 2025 May 28.

    PMID: 40437768BACKGROUND

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
SPONSOR

Study Record Dates

First Submitted

April 24, 2022

First Posted

August 18, 2022

Study Start

July 14, 2022

Primary Completion

April 27, 2024

Study Completion

April 27, 2024

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

No personal identifier will be shared. All data will be anonymous

Locations