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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 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
Sex
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
23/02/2015
Date of last participant enrolment
Anticipated
Actual
18/12/2018
Date of last data collection
Anticipated
Actual
31/12/2018
Sample size
Target
60
Accrual to date
Final
62
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
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
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
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
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
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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe improvement of cognitive deficits after whole-body cryotherapy - A randomised controlled trial.2021https://dx.doi.org/10.1016/j.exger.2021.111237
N.B. These documents automatically identified may not have been verified by the study sponsor.