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Trial registered on ANZCTR


Registration number
ACTRN12619001627145
Ethics application status
Approved
Date submitted
19/09/2019
Date registered
25/11/2019
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Date results information initially provided
25/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The whole-body cryotherapy in mild cognitive impairment
Scientific title
The influence of whole-body cryotherapy on adults' cognitive deficits - a randomised controlled study
Secondary ID [1] 299346 0
St-842
Universal Trial Number (UTN)
U1111-1240-6260
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 314498 0
Dementia 314959 0
Condition category
Condition code
Alternative and Complementary Medicine 312840 312840 0 0
Other alternative and complementary medicine
Mental Health 312841 312841 0 0
Other mental health disorders
Neurological 313305 313305 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Whole-Body Cryotherapy (WBC).

A cryotherapy chamber (CR 2002, Wroclaw type, provided by Creator Sp. z o. o.), cooled by liquid nitrogen consists of two rooms: the vestibule/antechamber (temperature: -60 C-degrees) and the proper chamber (temperature – days: 1st day: -110 C-degrees, 2nd: - 115 C-degrees, 3rd: -120 C-degrees, 4th: -130 C-degrees, 5th and 6th: -135 C-degrees, 7th: -130 C-degrees, 8th: -125 C-degrees, 9th: -120 C-degrees, 10th: -115 C-degrees). There is no direct contact with the liquid nitrogen in this type of device.
The usual WBC session lasts for 2 minutes in the main chamber with 30 seconds extra for adaptation in the vestibule before and after the proper session. Each procedure is under control by the personnel - the interevntion was administered by physiotherapist.
A group of 5–6 people usually uses the device at the same time. Participants are required to wear shorts and t-shirt, gloves, headband or beanie, a nose and mouth mask, high-knee socks and wooden shoes. This outfit should be woollen or cotton to reduce the risk of injuries caused by cold. Before every WBC session participants had the blood pressure measured.
Participants undertake 10 whole-body cryotherapy sessions for two weeks (Monday–Friday without weekend).
Intervention code [1] 315616 0
Treatment: Other
Comparator / control treatment
The participants from the control (sham) group undertake 10 sessions for two weeks (Monday – Friday without weekend) in the low temperatures -50 ºC but not cryogenic ones in the proper chamber.
Control group
Placebo

Outcomes
Primary outcome [1] 321449 0
cognitive functions measured by DemTect® and Saint Louis University Mental Status Examination (SLUMS).
Timepoint [1] 321449 0
Baseline (T1), after the 10th WBC session (T2) and at follow-up after 2 weeks (T3) with primary timepoint T1 and T2
Secondary outcome [1] 374987 0
cognitive functions measured by Test Your Memory (TYM)
Timepoint [1] 374987 0
baseline (T1), after the 10th WBC session (T2) and at follow-up after 2 weeks (T3)
Secondary outcome [2] 374988 0
Self-report on “well-being” issues including: mood, vitality and sleep quality using Visual Analogue Scales (VAS) - a composite secondary outcome
Timepoint [2] 374988 0
baseline (T1), after the 10th WBC session (T2) and at follow-up after 2 weeks (T3)
Secondary outcome [3] 374989 0
depressive symptoms measured by 15-item Geriatric Depression Scale (GDS)
Timepoint [3] 374989 0
baseline (T1), after the 10th WBC session (T2) and at follow-up after 2 weeks (T3)
Secondary outcome [4] 374990 0
The cytokine - IL-6 level determined by ELISA in plasma.
Timepoint [4] 374990 0
baseline (T1), after the 10th WBC session (T2) and at follow-up after 2 weeks (T3)
Secondary outcome [5] 376190 0
The BDNF level determined by ELISA in plasma.
Timepoint [5] 376190 0
baseline (T1), after the 10th WBC session (T2) and at follow-up after 2 weeks (T3)
Secondary outcome [6] 376191 0
The NGF level determined by ELISA in plasma.
Timepoint [6] 376191 0
baseline (T1), after the 10th WBC session (T2) and at follow-up after 2 weeks (T3)
Secondary outcome [7] 376192 0
NO level in plasma was determined by Griess reaction.
Timepoint [7] 376192 0
baseline (T1), after the 10th WBC session (T2) and at follow-up after 2 weeks (T3)
Secondary outcome [8] 377173 0
The cytokine - IL-10 level determined by ELISA in plasma.
Timepoint [8] 377173 0
baseline (T1), after the 10th WBC session (T2) and at follow-up after 2 weeks (T3)

Eligibility
Key inclusion criteria
Medically stable (based on physical examination, medical history and vital signs at screening) adults with a diagnosis of mild cognitive impairment (MCI; F06.7 according to research criteria of International Classification of Diseases, ICD-10) (World Health Organization, 2004) with additional inclusion criteria based on the Montreal Cognitive Assessment (MoCA) test (Magierska, Magierski, Fendler, Kloszewska, & Sobów, 2012; Nasreddine et al., 2005; Talarowska, Florkowski, Zboralski, & Galecki, 2011) (scores between 20 and 26).
Minimum age
45 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria included 1) a lack of or more advanced cognitive decline (20<MoCA>26), 2) depression, 3) previous exposure to WBC 4) being over 85 years old and 5) all standard contraindications to use WBC (e.g. alcohol and drug abuse, inability to understand questions and written information, psychosis, suicidal thoughts, standard contraindications to use WBC (e.g. acute respiratory diseases, acute cardiovascular disease like coronary disease, circulatory insufficiency, unstable hypertension, cold intolerance, claustrophobia, cryoglobulinemia, cancer, deep vein diseases, hypothyroidism, neuropathies, purulent skin changes, Reynaud disease).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21876 0
Poland
State/province [1] 21876 0

Funding & Sponsors
Funding source category [1] 303862 0
Government body
Name [1] 303862 0
Polish Ministry of Science and Higher Education
Address [1] 303862 0
20 Hoza Street,
00-529 Warszawa
Country [1] 303862 0
Poland
Primary sponsor type
Government body
Name
Polish Ministry of Science and Higher Education
Address
20 Hoza Street,
00-529 Warszawa
Country
Poland
Secondary sponsor category [1] 303999 0
None
Name [1] 303999 0
Address [1] 303999 0
Country [1] 303999 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304372 0
Bioethical Committee, Wroclaw Medical Univeristy
Ethics committee address [1] 304372 0
1 Pasteura Str., 50-367 Wroclaw
Ethics committee country [1] 304372 0
Poland
Date submitted for ethics approval [1] 304372 0
05/01/2015
Approval date [1] 304372 0
29/01/2015
Ethics approval number [1] 304372 0
KB-665/2014

Summary
Brief summary
Mild Cognitive Impairments (MCI) and dementia are still incurable. The Whole-Body Cryotherapy (WBC) - short, cyclic exposure to extremely low temperatures - has proven anti-inflammatory and anti-oxidative effects. It can also induce hormonal, lipid and neural changes. This research project aimed to determine the efficacy of cognitive functioning and the biological mechanisms of whole-body cryotherapy in people with mild cognitive impairment (MCI).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96726 0
Prof Joanna Rymaszewska
Address 96726 0
Department of Psychiatry
Wroclaw Medical University
10 Pasteura, 50-367 Wroclaw
Country 96726 0
Poland
Phone 96726 0
+48717841600
Fax 96726 0
+48717841602
Email 96726 0
joanna.rymaszewska@umed.wroc.pl
Contact person for public queries
Name 96727 0
Prof Joanna Rymaszewska
Address 96727 0
Department of Psychiatry
Wroclaw Medical University
10 Pasteura, 50-367 Wroclaw
Country 96727 0
Poland
Phone 96727 0
+48717841600
Fax 96727 0
+48717841602
Email 96727 0
joanna.rymaszewska@umed.wroc.pl
Contact person for scientific queries
Name 96728 0
Dr Bartlomiej Stanczykiewicz
Address 96728 0
Department of Nervous System Diseases
Faculty of Health Science
Wroclaw Medical University
Bartla 5 Str., 51-618 Wroclaw, Poland
Country 96728 0
Poland
Phone 96728 0
+48717841600
Fax 96728 0
+48717841602
Email 96728 0
bartlomiej.stanczykiewicz@umed.wroc.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No patient permission to share data outside this study.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 4949 0
03/05/2018
Joanna Rymaszewska, Katarzyna M. Urbanska, Dorota Szczesniak, Bartlomiej Stanczykiewicz, Elzbieta Trypka, Agnieszka Zablocka.: The improvement of memory deficits after whole-body cryotherapy - the first report
CryoLetters 2018 Vol.39 no.3; s.190-195
Attachments [1] 4949 0
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 4950 0
Conference abstract
Citation/DOI/link/details [1] 4950 0
Katarzyna Urbanska, Bartlomiej Stanczykiewicz, Dorota Szczesniak, Elzbieta Trypka, Lilla Pawlik-Sobecka, Sylwia Placzkowska, Izabela Kokot, Agnieszka Zablocka, Joanna Rymaszewska.: Does whole-body cryotherapy improve cognition?
Eur.Psychiatr. 2018 Vol.48 suppl.; s.S312-S313 poz.PW0495
26th European Congress of Psychiatry. Nice, France, 3-6 March 2018
Attachments [1] 4950 0
Citation type [2] 4951 0
Conference abstract
Citation/DOI/link/details [2] 4951 0
Joanna Rymaszewska, Dorota Szczesniak, Elzbieta Trypka, Katarzyna Urbanska, Bartlomiej Stanczykiewicz, Karolina Pieniawska, Jakub Ubysz, Agnieszka Zablocka.: Krioterapia ogólnoustrojowa a funkcje poznawcze u osób z zaburzeniami pamieci - wyniki wstepne. Curr.Probl.Psychiatr. 2017 Congress book; s.22
XIX Lubelskie Spotkania Naukowe. Lublin, 15-16 september 2017
Attachments [2] 4951 0
Citation type [3] 4952 0
Conference abstract
Citation/DOI/link/details [3] 4952 0
Katarzyna Urbanska, Bartlomiej Stanczykiewicz, Dorota Szczesniak, Elzbieta Trypka, Agnieszka Zablocka, Joanna Rymaszewska.: Mild cognitive impairments and whole-body cryotherapy - placebo control study
Eur.Psychiatr. 2017 Vol.41 suppl.; s.S665-S666 poz.EV0801
25th European Congress of Psychiatry. Florence, Italy, 1-4 April 2017. Abstract book
Attachments [3] 4952 0
Citation type [4] 4953 0
Conference abstract
Citation/DOI/link/details [4] 4953 0
Joanna Rymaszewska, Elzbieta Trypka, Dorota Szczesniak, Katarzyna Urbanska, Bartlomiej Stanczykiewicz, Izabela Kokot, Sylwia Placzkowska, Lilla Pawlik-Sobecka, Agnieszka Zablocka.: Whole-body cryotherapy in memory deficits - modulatory effect on clinical and immunology variables
W:18th IPA International Congress "Towards mental health care for all older adults". San Francisco, CA, USA, 6-9 September 2016. Book of abstracts - preliminary version (updated 9/3/2016); s.40
Attachments [4] 4953 0
Citation type [5] 4954 0
Conference abstract
Citation/DOI/link/details [5] 4954 0
Joanna Rymaszewska, Katarzyna Urbanska, Elzbieta Trypka, Bartlomiej Stanczykiewicz, Dorota Szczesniak.: Is whole-body cryotherapy used in neurology and rheumatology valuable for memory loss? - preliminary report
W:31st International Conference of Alzheimer's Disease International. Budapest, Hungary, 21-24 April 2016. Abstract book; s.232 poz.P085
Adres url: http://www.adi2016.org/abstracts.html
Attachments [5] 4954 0
Citation type [6] 4955 0
Conference abstract
Citation/DOI/link/details [6] 4955 0
Dorota Szczesniak, Katarzyna Urbanska, Elzbieta Trypka, Bartlomiej Stanczykiewicz, Joanna Rymaszewska.: Whole-body cryostimulation as possible prevention of cognitive deterioration
W:25th Alzheimer Europe Conference "Dementia: putting strategies and research into practice". Ljubljana, Slovenia, 2-4 September 2015. Abstract book; s.96 PO4.15
Attachments [6] 4955 0
Citation type [7] 4956 0
Conference abstract
Citation/DOI/link/details [7] 4956 0
Bartlomiej Stanczykiewicz, Dorota Szczesniak, Joanna Rymaszewska.: Whole-body cryotherapy in dementia
Eur.Psychiatr. 2015 Vol.30 suppl.1; poz.1454
23rd European Congress of Psychiatry. Vienna (Austria), 28-31 March 2015. Abstracts on USB-Drive
Attachments [7] 4956 0
Results – basic reporting
Results – plain English summary