The Effect of Whole Body Cryotherapy on Recovery and Performance: a Randomized Controlled Trial (Cryotherapy)

August 7, 2019 updated by: Ron Clijsen, University of Applied Sciences and Arts of Southern Switzerland
This study investigates the effects of whole-body cryotherapy vs. cold-water immersion after a muscle damage protocol.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this study the effects of a single- or multiple whole body cryotherapy (-135°C for max. 2 minutes) vs. cold water immersion (10°C for 15 min) and a passive control group (20 min supine position) are compared. These effects are examined after a muscle damage protocol of the frontal thighs (3 x 30 jumps). The objective recovery parameters are vertical jump, maximum voluntary contraction of the anterior thigh muscle, heart rate, blood pressure, skin-core body temperature and the oxygen saturation of the thigh muscles. Subjective recovery parameters are the local muscle soreness details and the general exhaustion details. The parameters are directly and 24, 48 and measured 72 hours after exposure. The aim is to elicit the effects of whole body cooling to make recommendations to. The current scientific knowledge situation calls for further studies to whole body cooling.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Fachhochschule Südschweiz

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Only healthy young subjects 18-35 years no musculoskeletal surgery in trunk and lower extremities injury history in trunk and lower extremity for more than one year subjects taking anticonceptive medication are allowed to participate

Exclusion Criteria:

Actual injuries or injuries for less than one year in trunk and /or lower extremities injury history in trunk and lower extremity for more than one year with complaints anxiety of cooling subjects on medication pace maker cardiovascular disease pregnancy skeletal problems appendectomy for less than two years Morbus Raynaud syndrome

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Whole-body cryotherapy
The effects of whole-body cryotherapy (-135°C for 2 minutes) are investigated after a muscle damage protocol.
Device: Kryosauna Space Cabin
The whole body cryotherapy device is able to generatue temperatures up to -195°C for 3 minutes. In this study, we generate temperatures of -135°C for 2 minutes as proposed in the manual. The participant will enter the cabin in cold-resistant shoes and will remain in standing position during the whole procedure. The cold temperature is generated by vaporization of liquid nitrogen.
Other Names:
  • Cryomed s.r.o.
Other: Cold-water immersion
The effects of cold-water immersion (10°C for 15 minutes) are investigated after a muscle damage protocol.
Other: cold water tub
The tub will be filled with cold water up to the sternal level of the participants. Adding ice will ensure a constant temperature. The participant will sit inside the tub during the whole procedure.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vertical Jump
Time Frame: 72 hours
Vertical Jump will be assessed in cm with the Just Jump Plate
72 hours
Maximum voluntary contraction
Time Frame: 72 hours
Maximum voluntary contraction will be assessed in kg on a custom made ergometer chair (COR 1)
72 hours
Delayed onset of muscle soreness
Time Frame: 72 hours
DOMS will be assessed using a visual analog scale (0-10 cm)
72 hours
Ratings of perceived exertion
Time Frame: 72 hours
RPE will be assessed using a BORG scale (6-20)
72 hours
Skin temperature
Time Frame: 60 minutes
Skin temperature of the neck, right scapula, right dorsal hand, right frontal thigh, right shin are assessed in °C using thermocouples (iButtons)
60 minutes
Core temperature
Time Frame: 60 minutes
Core temperature will be assessed in °C via the ear
60 minutes
Cardiovascular measurements
Time Frame: 60 min
Heart rate will be measured in beats per minute and bloop pressure will be measured in mm/Hg using an blood pressure monitor
60 min
Oxygenation of the right thigh muscle
Time Frame: 60 min
Oxygenation of the right thigh muscle will be assessed in % using a near infrared spectometer.
60 min

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Applied Sciences and Arts of Southern Switzerland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vrije Universiteit Brussel
THIM - die internationale Hochschule für Physiotherapie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ronaldus Clijsen, PhD, Fachhochschule Südschweiz

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PB_2016-01125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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