NCT04902924

Brief Summary

The overall aim of this study is, to evaluate the effectiveness of repeated cold- and warm water immersion on performance recovery after muscle damage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Oct 2021

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 29, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

September 24, 2025

Completed
Last Updated

October 7, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

April 29, 2021

Results QC Date

July 30, 2025

Last Update Submit

September 25, 2025

Conditions

Keywords

cold water immersionwarm water immersionmuscle damagerecovery

Outcome Measures

Primary Outcomes (7)

  • Maximum Voluntary Isometric Contraction (N)

    maximun voluntary isometric contraction of the knee extensor muscle will be assessed.

    baseline to 72 hours

  • Delayed Onset of Muscle Soreness (DOMS)

    delayed onset of muscle soreness will be measured using a 0-10 scale, where 0 indicated no soreness and 10 indicates maximum soreness of the knee extensor muscles

    baseline to 72 hours

  • Muscle Swelling

    swelling of the knee extensor muscle will be performed using a ultrasound device.

    baseline to 72 hours

  • Creatine-kinase (U/l)

    using a blood sample (6 ml), creatine-kinase will be assessed

    baseline to 72 hours

  • Muscle Blood Oxygenation

    Muscle oxygenation saturation (SmO2) of the knee extensor muscle will be measured using near-infrared spectroscopy device. Oxygenated haemoglobin (oxyHb), deoxygenated haemoglobin (deoxyHb) and total haemoglobin (TotHb) were assessed in arbitrary units and SmO2 was calculated as oxyHb/TotHb x 100 value (%)

    through recovery intervention up to 30 minutes

  • Skin Temperature (°C)

    Skin temperature will be measured using a near infrared thermography camera

    through recovery intervention up to 30 minutes

  • Core Temperature (°C)

    core temperature will be measured using temperature pill that will provide real time values from the gastrointestinal region

    through recovery intervention up to 30 minutes

Study Arms (3)

Repeated cold-water immersion

EXPERIMENTAL

In this arm, the participants undergo repeated cold water immersion at 10°C for 2 x 5 min. Between the immersion, a break will be conducted 2.5 min. Participants will be immersed up to the iliac crest

Behavioral: repeated cold water therapy

Repeated warm-water immersion

ACTIVE COMPARATOR

In this arm, the participants undergo repeated warm water immersion at 40°C for 2 x 5 min. Between the immersion, a break will be conducted 2.5 min. Participants will be immersed up to the iliac crestParticipants will be immersed up to the iliac crest.

Behavioral: repeated warm water therapy

Control

OTHER

In this arm, the participants undergo the control intervention which comprises to remain seated for 12.5 min. The participants, that will perform the muscle damaging protocol under hypoxia will also be treated with the control condition.

Other: control

Interventions

This information can be found the description of the experimental arm.

Repeated cold-water immersion

This information can be found the description of the experimental arm.

Repeated warm-water immersion
controlOTHER

This information can be found the description of the experimental arm.

Control

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy participants
  • No surgeries
  • No previous injuries
  • Anticonceptiva allowed

You may not qualify if:

  • Acute injuries or current pain situations
  • Cryophobia
  • Fear
  • Pregnancy
  • Raynaud syndrome
  • Medication intake

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Applied Sciences and Arts of Southern Switzerland

Landquart, Kanton Graubünden, 7302, Switzerland

Location

Related Publications (2)

  • Wellauer V, Clijsen R, Bianchi G, Riggi E, Hohenauer E. No acceleration of recovery from exercise-induced muscle damage after cold or hot water immersion in women: A randomised controlled trial. PLoS One. 2025 May 7;20(5):e0322416. doi: 10.1371/journal.pone.0322416. eCollection 2025.

  • Hohenauer E, Bianchi G, Wellauer V, Taube W, Clijsen R. Acute physiological responses and muscle recovery in females: a randomised controlled trial of muscle damaging exercise in hypoxia. BMC Sports Sci Med Rehabil. 2024 Mar 22;16(1):70. doi: 10.1186/s13102-024-00861-1.

Related Links

Results Point of Contact

Title
Vanessa Wellauer
Organization
Rehabilitation and Exercise Science Laboratory (RESlab), University of Applied Sciences and Arts of Southern Switzerland (SUPSI)

Study Officials

  • Ron Clijsen, PhD

    University of Applied Sciences and Arts of Southern Switzerland

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: This study is a randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of research

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 26, 2021

Study Start

October 1, 2021

Primary Completion

April 30, 2022

Study Completion

May 1, 2022

Last Updated

October 7, 2025

Results First Posted

September 24, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations