Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001142921
Ethics application status
Approved
Date submitted
19/03/2020
Date registered
2/11/2020
Date last updated
2/11/2020
Date data sharing statement initially provided
2/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The influence of whole-body cryotherapy on physiological blood indicators, oxidative stress and selected disease markers in people with multiple sclerosis
Scientific title
The influence of whole-body cryotherapy on hemorheological parameters, indicators of oxidative stress, level of interleukin 6 and matrix metallopeptidase 9 and level of Vitamin D in women with multiple sclerosis and healthy controls.
Secondary ID [1] 298794 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 313746 0
Condition category
Condition code
Physical Medicine / Rehabilitation 312149 312149 0 0
Physiotherapy
Neurological 312150 312150 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study was attended by 30 women with multiple sclerosis and 15 women without neurological and other chronic diseases. There were 3 study groups: interventional and 2 active control groups. The participants were recruited through posted advertisement at Malopolska Cryotherapy Rehabilitation Center in Krakow. Allocation of subjects into different groups was done through volunteer sampling. The women were included in the research program after obtaining the consent from the neurologist, physician and after consultation with the physiotherapist (assessment of the health status, functional status, course of the disease, type of the current treatment and medicines). Women from the interventional group took part in 20 whole body cryotherapy sessions 5 times a week for 4 weeks. Whole body cryotherapy (WBC) was carried at the Malopolska Cryotherapy Rehabilitation Center in Krakow. Parameters in the cryochamber were as following:
· Atrium temperature: -60 ° C,
· Chamber temperature: -120 ° C.
The time of a single WBC session during study period was respectively:
· 1.5 min (1 treatment),
· 2 minutes (2 treatments),
· 3 minutes (3-20 treatments).
Women entering the cryochamber were dressed in swimsuits, high woolen socks and shoes with a high wooden sole. Parts of the body most exposed to low temperature were covered (the subjects had gloves, head covering and face mask). After being exposed to cryotherapy, the patients warmed up with light cycling on a cycloergometer for 30 minutes. Treatments were supervised directly by a trained physiotherapist. A doctor was present at the Rehabilitation Center throughout the entire duration of the treatment. To assess adherence to the intervention a session attendance checklist was used.
Intervention code [1] 316901 0
Treatment: Other
Comparator / control treatment
There were 2 active control groups. The first control group consisted of women with diagnosed multiple sclerosis. This group had no intervention in the form of whole body cryotherapy. The participants of this group were subjected to a single assessment of studied indicators. The second control group consisted of women without neurological and other chronic diseases who underwent the same cryotherapy treatment as interventional group (20 whole body cryotherapy sessions: 5 times a week for 4 weeks).
Control group
Active

Outcomes
Primary outcome [1] 322928 0
Assessment of changes in rheological properties of blood such as the erythrocyte elongation index (EI), erythrocyte aggregation indexes (AI), i.e. AMP - total aggregation, T1/2 - half time of total aggregation which were determined using Analizator Laser-assisted Optical Rotational Cell Analyser (LORCA) RR Mechatronics.
Timepoint [1] 322928 0
Baseline and after a series of 20 cryotherapy treatments
Primary outcome [2] 323262 0
Assessment of the change in proteinogram level (total protein, albumin, alpha-1 globulin, alpha-2 globulin, beta-1 globulin, beta-2 globulin, gamma globulin, A / G index) in blood serum. The tests were carried out using the Cobas 6000, Roche analyzer (biuret method) and Minicap Sebia analyzer (capillary method).
Timepoint [2] 323262 0
Baseline and after a series of 20 cryotherapy treatments
Primary outcome [3] 323263 0
Assessment of hematological parameters of the blood (Hemoglobin, g/dL; Hematocrit, %; Erythrocytes (x1012/L); Leukocyte count (x109/L); Platelet count (x109/L)) using the ABX MICROS 60 hematology analyzer (USA).
Timepoint [3] 323263 0
Baseline and after a series of 20 cryotherapy treatments
Secondary outcome [1] 380262 0
Evaluation of changes in levels of oxidative stress markers: total antioxidative status/capacity - ImAnOx (TAS/TAC), Total Oxidative Status (TOS) in blood serum by enzyme-linked immunosorbent method (ELISA) using high-sensitivity reagent kits from DRG Instruments Gmbh (Germany) and SunRed Bio (China).
Timepoint [1] 380262 0
Baseline and after a series of 20 cryotherapy treatments
Secondary outcome [2] 381344 0
Evaluation of changes in the level of calcidiol (D-OH 25) in blood serum by enzyme-linked immunosorbent method (ELISA) using high-sensitivity reagent kits from DRG Instruments Gmbh (Germany) and SunRed Bio (China).
Timepoint [2] 381344 0
Baseline and after a series of 20 cryotherapy treatments
Secondary outcome [3] 381345 0
Evaluation of changes in the level of NO in the blood serum was determined using a spectrophotometric method using the Nitrate/Nitrite Colorimetric Assay Kit; Cayman Chemical Company.
Timepoint [3] 381345 0
Baseline and after a series of 20 cryotherapy treatments
Secondary outcome [4] 381346 0
Evaluation of changes in the level of uric acid in the blood serum using the Cobas 6000 analyzer, Roche (enzymatic method with uricase and peroxidase)
Timepoint [4] 381346 0
Baseline and after a series of 20 cryotherapy treatments
Secondary outcome [5] 381347 0
Evaluation of changes in the level of Interleukin 6 (IL-6 [pg/ml]) in blood serum by enzyme-linked immunosorbent method (ELISA) using high-sensitivity reagent kits from DRG Instruments Gmbh (Germany) and SunRed Bio (China).
Timepoint [5] 381347 0
Baseline and after a series of 20 cryotherapy treatments
Secondary outcome [6] 381348 0
Assessment of the change in the level of matrix metallopeptidase 9 (MMP-9 [ng/mL]) in blood serum by enzyme-linked immunosorbent method (ELISA) using high-sensitivity reagent kits from DRG Instruments Gmbh (Germany) and SunRed Bio (China).
Timepoint [6] 381348 0
Baseline and after a series of 20 cryotherapy treatments
Secondary outcome [7] 381349 0
Assessment of functional state using Expanded Disability Status Scale.
Timepoint [7] 381349 0
Baseline and after a series of 20 cryotherapy treatments
Secondary outcome [8] 381350 0
Assessment of quality of life using Multiple Sclerosis Impact Scale
Timepoint [8] 381350 0
Baseline and after a series of 20 cryotherapy treatments

Eligibility
Key inclusion criteria
• diagnosis: multiple sclerosis - ICD10: G35 (confirmed by imaging: magnetic resonance imaging, cerebrospinal fluid examination, examination of visual evoked potentials)
• age: 30 - 55 years old
• Expanded Disability Status Scale - value from 0 to 6
• no contraindications to whole body cryotherapy
• written consent of the patient to participate in the study
Minimum age
30 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• unregulated hypertension
• atherosclerosis
• diabetes
• local blood supply disorders
• bladder and urinary tract diseases
• consuming more than 4 cups of coffee or more than 2 alcoholic beverages per day
• contraindications to the use of whole body cryotherapy
• participation in other forms of physical activity during the study
• no consent to participate in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



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
14/11/2018
Date of last participant enrolment
Anticipated
Actual
5/08/2019
Date of last data collection
Anticipated
Actual
5/09/2019
Sample size
Target
45
Accrual to date
Final
45
Recruitment outside Australia
Country [1] 22363 0
Poland
State/province [1] 22363 0
Malopolska

Funding & Sponsors
Funding source category [1] 303352 0
University
Name [1] 303352 0
University of Physical Education in Cracow
Country [1] 303352 0
Poland
Primary sponsor type
Individual
Name
Bartlomiej Ptaszek
Address
University of Physical Education in Cracow
Doctoral Studies at the Physiotherapy Department
al. Jana Pawla II 78
Kraków
Post code: 31-571
Poland
Country
Poland
Secondary sponsor category [1] 303382 0
Individual
Name [1] 303382 0
Aneta Telegów
Address [1] 303382 0
University of Physical Education in Cracow
Physiotherapy Department
al. Jana Pawla II 78
Kraków
Post code: 31-571
Poland
Country [1] 303382 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303881 0
Bioethical Commission of the Regional Medical Chamber in Krakow
Ethics committee address [1] 303881 0
Ethics committee country [1] 303881 0
Poland
Date submitted for ethics approval [1] 303881 0
Approval date [1] 303881 0
08/05/2018
Ethics approval number [1] 303881 0
87/KBL/OIL/2018

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95110 0
Mr Bartlomiej Ptaszek
Address 95110 0
University of Physical Education in Cracow
Doctoral Studies at the Physiotherapy Department
al. Jana Pawla II 78
Kraków
Post code: 31-571
Poland
Country 95110 0
Poland
Phone 95110 0
+48698914837
Fax 95110 0
Email 95110 0
[email protected]
Contact person for public queries
Name 95111 0
Bartlomiej Ptaszek
Address 95111 0
University of Physical Education in Cracow
Doctoral Studies at the Physiotherapy Department
al. Jana Pawla II 78
Kraków
Post code: 31-571
Poland
Country 95111 0
Poland
Phone 95111 0
+48698914837
Fax 95111 0
Email 95111 0
[email protected]
Contact person for scientific queries
Name 95112 0
Bartlomiej Ptaszek
Address 95112 0
University of Physical Education in Cracow
Doctoral Studies at the Physiotherapy Department
al. Jana Pawla II 78
Kraków
Post code: 31-571
Poland
Country 95112 0
Poland
Phone 95112 0
+48698914837
Fax 95112 0
Email 95112 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
EmbaseEffect of Whole-Body Cryotherapy on Oxidant-Antioxidant Imbalance in Women with Multiple Sclerosis.2023https://dx.doi.org/10.3390/jcm12185958
N.B. These documents automatically identified may not have been verified by the study sponsor.