ColdCryotherapyNCT02847663
The Effect of Whole Body Cryotherapy on Recovery and Performance: a Randomized Controlled Trial
A study testing Kryosauna Space Cabin and cold water tub in people with Cold, run by University of Applied Sciences and Arts of Southern Switzerland at 1 site in Switzerland.
Trial summary
This study investigates the effects of whole-body cryotherapy vs. cold-water immersion after a muscle damage protocol. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cold
- What is being tested?
- Kryosauna Space Cabin and cold water tub
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the effects of whole-body cryotherapy vs. cold-water immersion after a muscle damage protocol.
Read the 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.
- Conditions
- Cold
- Being tested
- Kryosauna Space Cabin, cold water tub
- Keywords
- Cold, recovery
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kryosauna Space CabinDevice
Also called Cryomed s.r.o.
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.
cold water tubOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Whole-body cryotherapy | Experimental | The effects of whole-body cryotherapy (-135°C for 2 minutes) are investigated after a muscle damage protocol. Receives: Device: Kryosauna Space Cabin |
| Cold-water immersion | Other | The effects of cold-water immersion (10°C for 15 minutes) are investigated after a muscle damage protocol. Receives: Other: cold water tub |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical Jump
Vertical Jump will be assessed in cm with the Just Jump Plate
Measured: 72 hours
Maximum voluntary contraction
Maximum voluntary contraction will be assessed in kg on a custom made ergometer chair (COR 1)
Measured: 72 hours
Delayed onset of muscle soreness
DOMS will be assessed using a visual analog scale (0-10 cm)
Measured: 72 hours
Ratings of perceived exertion
RPE will be assessed using a BORG scale (6-20)
Measured: 72 hours
Skin temperature
Skin temperature of the neck, right scapula, right dorsal hand, right frontal thigh, right shin are assessed in °C using thermocouples (iButtons)
Measured: 60 minutes
Core temperature
Core temperature will be assessed in °C via the ear
Measured: 60 minutes
Cardiovascular measurements
Heart rate will be measured in beats per minute and bloop pressure will be measured in mm/Hg using an blood pressure monitor
Measured: 60 min
Oxygenation of the right thigh muscle
Oxygenation of the right thigh muscle will be assessed in % using a near infrared spectometer.
Measured: 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Applied Sciences and Arts of Southern Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- THIM - die internationale Hochschule für Physiotherapie, Vrije Universiteit Brussel
- Responsible party
- Principal investigator, Ron Clijsen, University of Applied Sciences and Arts of Southern Switzerland
- Investigators
- Ronaldus Clijsen, PhD, Principal investigator, Fachhochschule Südschweiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847663
- Sponsor's protocol ID
- PB_2016-01125
- Acronym
- Cryotherapy
- Status last verified
- Aug 2019
- First submitted
- 15 Jun 2016
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Whole Body Cryotherapy on Recovery and Performance: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02847663
- Acronym / sponsor ID
- Cryotherapy / PB_2016-01125
- Conditions
- Cold
- Keywords
- Cold, recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Applied Sciences and Arts of Southern SwitzerlandUniversity, hospital or other
- Collaborators
- THIM - die internationale Hochschule für Physiotherapie, Vrije Universiteit Brussel
- Study start
- Apr 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the effects of whole-body cryotherapy vs. cold-water immersion after a muscle damage protocol.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole-body cryotherapy | Experimental | Device: Kryosauna Space CabinThe effects of whole-body cryotherapy (-135°C for 2 minutes) are investigated after a muscle damage protocol. |
| Cold-water immersion | Other | Other: cold water tubThe effects of cold-water immersion (10°C for 15 minutes) are investigated after a muscle damage protocol. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kryosauna Space CabinAlso: Cryomed s.r.o.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. | Device | Whole-body cryotherapy |
| cold water tubThe 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. | Other | Cold-water immersion |
Primary outcome
Vertical Jump
Time frame: 72 hours
Vertical Jump will be assessed in cm with the Just Jump Plate
Maximum voluntary contraction
Time frame: 72 hours
Maximum voluntary contraction will be assessed in kg on a custom made ergometer chair (COR 1)
Delayed onset of muscle soreness
Time frame: 72 hours
DOMS will be assessed using a visual analog scale (0-10 cm)
Ratings of perceived exertion
Time frame: 72 hours
RPE will be assessed using a BORG scale (6-20)
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)
Core temperature
Time frame: 60 minutes
Core temperature will be assessed in °C via the ear
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronaldus Clijsen, PhD principal investigator
Fachhochschule Südschweiz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kryosauna Space Cabin and cold water tub in people with Cold, run by University of Applied Sciences and Arts of Southern Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertical Jump (time frame: 72 hours). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.