Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000300370
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
3/12/2025
Date registered
Help: Date registered
10/03/2026
Date last updated
Help: Date last updated
10/03/2026
Date data sharing statement initially provided
Help: Data sharing statement date
10/03/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Whole Body Cryotherapy (WBC) and exercise on functional status in patients with multiple sclerosis (MS)
Scientific title
The impact of systemic cryotherapy and exercise on the psychophysical functioning of patients with multiple sclerosis
Additional trial identifiers [1] 316086 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Multiple Sclerosis 339965 0
Condition category
Condition code
Physical Medicine / Rehabilitation 336184 336184 0 0
Physiotherapy
Mental Health 336185 336185 0 0
Depression
Mental Health 336186 336186 0 0
Anxiety
Neurological 336187 336187 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The aim of the study was to evaluate the effect of whole-body cryotherapy and exercise on depression and anxiety, muscle strength and mobility in patients with multiple sclerosis.
Patients were randomly divided into three experimental groups:
Group 1 (CryoGym) – 23 patients participating in whole-body cryotherapy and in strengthening exercises using Thera-Band equipment,
Group 2 (Cryo) – 23 patients participating in whole-body cryotherapy treatments,
Group 3 (Gym) – 23 patients participating in lower limb exercise using Thera-Band equipment to strengthen their lower limb muscles.
The patients' psychofunctional status (mood, anxiety, depression) was assessed and muscle strength and muscle function parameters were measured.

Assessments were conducted at two predefined time points: baseline (T1), prior to the initiation of treatment, and post-intervention (T2), after 10 days of therapy and a two-day washout period to avoid fatigue-related effects.

In the study, the primary outcome is RMI, and secondary outcomes include peak torque, total work, and average power. The Rivermead Mobility Index assesses general motor skills and functional mobility, while the isokinetic measurement shows the biomechanical characteristics of the knee extensors and flexors.
Intervention code [1] 332693 0
Rehabilitation
Description of the comparator or control
Reference comparator was Group 3 (Gym) – 23 patients participating in lower limb exercise
Control group
Active

Outcomes
Primary outcome [1] 343731 0
Depression
Timepoint [1] 343731 0
Baseline and 10 days post-commencement of intervention
Primary outcome [2] 343733 0
Anxiety
Timepoint [2] 343733 0
Baseline and 10 days post-commencement of intervention
Primary outcome [3] 343734 0
Mobility and locomotion
Timepoint [3] 343734 0
Baseline and 10 days post-commencement of intervention
Secondary outcome [1] 455433 0
Mood
Timepoint [1] 455433 0
Baseline and 10 days post-commencement of intervention
Secondary outcome [2] 455435 0
Muscle strength
Timepoint [2] 455435 0
Baseline and 10 days post-commencement of intervention

Eligibility
Key inclusion criteria
• consent to participate in the study,
• diagnosed Multiple sclerosis (MS),
• a period of disease remission (minimum 6 months since the last relapse),
• independent mobility (Expanded Disability Status Scale, EDSS 0-6),
• approval from the attending physician,
Minimum age
30 Years
Maximum age
60 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
• adherence to training units below 70%,
• use of other non-pharmacological (e.g. rehabilitation) forms of support during the project,
• lack of consent to participate in the study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed in sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were randomized using a computer-generated sequence.
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
1/05/2013
Date of last participant enrolment
Anticipated
Actual
28/02/2014
Date of last data collection
Anticipated
Actual
31/03/2014
Sample size
Target
70
Accrual to date
Final
69
Recruitment outside Australia
Country [1] 27653 0
Poland
State/province [1] 27653 0
Wroclaw

Funding & Sponsors
Funding source category [1] 320684 0
University
Name [1] 320684 0
Wroclaw University of Health and Sport Sciences
Country [1] 320684 0
Poland
Primary sponsor type
University
Name
Wroclaw University of Health and Sport Sciences
Address
Country
Poland
Secondary sponsor category [1] 323320 0
None
Name [1] 323320 0
Address [1] 323320 0
Country [1] 323320 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319224 0
Wroclaw University of Health and Sport Sciences Ethic Commitee
Ethics committee address [1] 319224 0
Ethics committee country [1] 319224 0
Poland
Date submitted for ethics approval [1] 319224 0
Approval date [1] 319224 0
12/07/2011
Ethics approval number [1] 319224 0

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

Contacts
Principal investigator
Name 146666 0
Dr Malwina Pawik
Address 146666 0
WROCLAW UNIVERSITY OF HEALTH AND SPORT SCIENCES; al. I.J. Paderewskiego 35; 51-612 Wroclaw; Poland
Country 146666 0
Poland
Phone 146666 0
+48713473522
Fax 146666 0
Email 146666 0
[email protected]
Contact person for public queries
Name 146667 0
dr Malwina Pawik
Address 146667 0
WROCLAW UNIVERSITY OF HEALTH AND SPORT SCIENCES; al. I.J. Paderewskiego 35; 51-612 Wroclaw; Poland
Country 146667 0
Poland
Phone 146667 0
+48713473522
Fax 146667 0
Email 146667 0
[email protected]
Contact person for scientific queries
Name 146668 0
Prof. Wioletta Dziubek-Rogowska
Address 146668 0
WROCLAW UNIVERSITY OF HEALTH AND SPORT SCIENCES; al. I.J. Paderewskiego 35; 51-612 Wroclaw; Poland
Country 146668 0
Poland
Phone 146668 0
+48713473522
Fax 146668 0
Email 146668 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified individual participant data:
• Safety data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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
No additional documents have been identified.