Quality of LifeNCT04177563
Whole Body Cryotherapy and Morphological and Rheological Indicators
A study testing whole body cryostimulation in people with Quality of Life, run by University School of Physical Education, Krakow, Poland.
Trial summary
The aim of the planned study was to evaluate the effect of repeated cryostimulation treatments on immunological, morphological, and biochemical indicators of the peripheral blood of healthy, young Men Read more about this study
- Who is it for?
- Ages 18 to 27 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- whole body cryostimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2013to 20 Dec 2015
- 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 27 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- informed consent for research;
- equal age and above 18 years of age;
- no contraindications to cryostimulation procedures;
- physically active
Who cannot join
- lack of informed consent for research
- children and adolescents under 18 years of age,
- patients with inflammatory diseases, infectious, autoimmune and cancer
About this study
Official title: Impact of Systemic Cryotherapy on the Rheological, Morphological, and Biochemical Blood Indicators
The aim of the planned study was to evaluate the effect of repeated cryostimulation treatments on immunological, morphological, and biochemical indicators of the peripheral blood of healthy, young Men
Read the detailed description
A group of 18 healthy men aged 19-26 participated in the study. The group included a group of ten students with high physical activity and a group of eight students with moderate physical activity.
Whole-body cryotherapy was performed in a cryochamber located in the Malopolska Cryotherapy Centre in Krakow (Poland) in the spring of 2013 and in the winter and spring of 2014.
The temperature inside the vestibule during the procedure was about -60 ºC and in the actual chamber about -120 ºC. The concentration of oxygen in the air of the cryochamber was kept constant at 21-22% and continuously controlled by two independent oxygen probes.
The participants of the study were subjected to 24 whole-body cryotherapy treatments (one treatment three times a week for two months). Before the procedure, they were informed about how to move and breathe in the cryochamber. Each entrance to the cryochamber was preceded by a 30-second adaptation period in the vestibule at a temperature of -60 ºC. Then the subjects entered the cryochamber for three minutes. During the treatment, the men wore short trousers, woollen socks and gloves, hats or headbands to protect against freezing and clogs. Moreover, the mouths and noses of the participants were covered with surgical masks, secured with a strip of gauze. During the procedure, the subjects were in permanent eye contact with the doctor and the staff.
- Conditions
- Quality of Life
- Being tested
- whole body cryostimulation
- Keywords
- whole-body cryotherapy, healthy men, blood components
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body cryostimulationOther
Whole-body cryotherapy
| Study group | Role | What they receive |
|---|---|---|
| a group of ten students with high physical activity | Experimental | The participants of the study were subjected to 24 whole-body cryotherapy treatments (one treatment three times a week for two months). Before the procedure, they were informed about how to move and breathe in the cryochamber. Each entrance to the cryochamber was preceded by a 30-second adaptation period in the vestibule at a temperature of -60 ºC. Then the subjects entered the cryochamber for three minutes.
Blood was collected from each participant (with an empty stomach) at a laboratory located at the Academy of Physical Education in Krakow, where after a ten-minute rest in a sitting position at room temperature (about 19 °C), blood was collected from the vein in the crook of the elbow by a laboratory diagnostician in accordance with applicable standards. Blood was collected 13 times. Receives: Other: whole body cryostimulation |
| a group of eight students with moderate physical activity | Experimental | The participants of the study were subjected to 24 whole-body cryotherapy treatments (one treatment three times a week for two months). Before the procedure, they were informed about how to move and breathe in the cryochamber. Each entrance to the cryochamber was preceded by a 30-second adaptation period in the vestibule at a temperature of -60 ºC. Then the subjects entered the cryochamber for three minutes.
Blood was collected from each participant (with an empty stomach) at a laboratory located at the Academy of Physical Education in Krakow, where after a ten-minute rest in a sitting position at room temperature (about 19 °C), blood was collected from the vein in the crook of the elbow by a laboratory diagnostician in accordance with applicable standards. Blood was collected 13 times. Receives: Other: whole body cryostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood collection in a group of participants with high and moderate physical activity
Determination of blood components
Measured: up to 3 months
Secondary outcomes (1)
blood collection in both groups tested
Determination of blood rheology
Measured: for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start1 Jun 2013
- Primary completion20 Dec 2015
- Study completion20 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University School of Physical Education, Krakow, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magdalena Kepinska-Szyszkowska, PhD, Principal investigator, University of Physical Education in Krakow, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177563
- Sponsor's protocol ID
- USPKrakow
- Status last verified
- Nov 2014
- First submitted
- 13 Nov 2019
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Systemic Cryotherapy on the Rheological, Morphological, and Biochemical Blood Indicators
- ClinicalTrials.gov ID
- NCT04177563
- Acronym / sponsor ID
- USPKrakow
- Conditions
- Quality of Life
- Keywords
- whole-body cryotherapy, healthy men, blood components
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University School of Physical Education, Krakow, PolandUniversity, hospital or other
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 20 Dec 2015 (actual)
- Study completion
- 20 Dec 2015 (actual)
- First posted
- 26 Nov 2019 (actual)
- 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.
The aim of the planned study was to evaluate the effect of repeated cryostimulation treatments on immunological, morphological, and biochemical indicators of the peripheral blood of healthy, young Men
Detailed description
A group of 18 healthy men aged 19-26 participated in the study. The group included a group of ten students with high physical activity and a group of eight students with moderate physical activity.
Whole-body cryotherapy was performed in a cryochamber located in the Malopolska Cryotherapy Centre in Krakow (Poland) in the spring of 2013 and in the winter and spring of 2014.
The temperature inside the vestibule during the procedure was about -60 ºC and in the actual chamber about -120 ºC. The concentration of oxygen in the air of the cryochamber was kept constant at 21-22% and continuously controlled by two independent oxygen probes.
The participants of the study were subjected to 24 whole-body cryotherapy treatments (one treatment three times a week for two months). Before the procedure, they were informed about how to move and breathe in the cryochamber. Each entrance to the cryochamber was preceded by a 30-second adaptation period in the vestibule at a temperature of -60 ºC. Then the subjects entered the cryochamber for three minutes. During the treatment, the men wore short trousers, woollen socks and gloves, hats or headbands to protect against freezing and clogs. Moreover, the mouths and noses of the participants were covered with surgical masks, secured with a strip of gauze. During the procedure, the subjects were in permanent eye contact with the doctor and the staff.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a group of ten students with high physical activity | Experimental | Other: whole body cryostimulationThe participants of the study were subjected to 24 whole-body cryotherapy treatments (one treatment three times a week for two months). Before the procedure, they were informed about how to move and breathe in the cryochamber. Each entrance to the cryochamber was preceded by a 30-second adaptation period in the vestibule at a temperature of -60 ºC. Then the subjects entered the cryochamber for three minutes. Blood was collected from each participant (with an empty stomach) at a laboratory located at the Academy of Physical Education in Krakow, where after a ten-minute rest in a sitting position at room temperature (about 19 °C), blood was collected from the vein in the crook of the elbow by a laboratory diagnostician in accordance with applicable standards. Blood was collected 13 times. |
| a group of eight students with moderate physical activity | Experimental | Other: whole body cryostimulationThe participants of the study were subjected to 24 whole-body cryotherapy treatments (one treatment three times a week for two months). Before the procedure, they were informed about how to move and breathe in the cryochamber. Each entrance to the cryochamber was preceded by a 30-second adaptation period in the vestibule at a temperature of -60 ºC. Then the subjects entered the cryochamber for three minutes. Blood was collected from each participant (with an empty stomach) at a laboratory located at the Academy of Physical Education in Krakow, where after a ten-minute rest in a sitting position at room temperature (about 19 °C), blood was collected from the vein in the crook of the elbow by a laboratory diagnostician in accordance with applicable standards. Blood was collected 13 times. |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- informed consent for research;
- equal age and above 18 years of age;
- no contraindications to cryostimulation procedures;
- physically active
Key exclusion criteria (3 listed)
- lack of informed consent for research
- children and adolescents under 18 years of age,
- patients with inflammatory diseases, infectious, autoimmune and cancer
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 |
|---|---|---|
| whole body cryostimulationWhole-body cryotherapy | Other | a group of eight students with moderate physical activity, a group of ten students with high physical activity |
Primary outcome
blood collection in a group of participants with high and moderate physical activity
Time frame: up to 3 months
Determination of blood components
1 secondary outcome
blood collection in both groups tested
Time frame: for 3 months
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 29 Nov 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.
Magdalena Kepinska-Szyszkowska, PhD principal investigator
University of Physical Education in Krakow, Poland
Questions about this trial
What is this clinical trial studying?
A study testing whole body cryostimulation in people with Quality of Life, run by University School of Physical Education, Krakow, Poland.
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 4 inclusion and 3 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 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
blood collection in a group of participants with high and moderate physical activity (time frame: up to 3 months). 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 29 Nov 2019.