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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000043336p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
14/10/2025
Date registered
Help: Date registered
12/01/2026
Date last updated
Help: Date last updated
12/01/2026
Date data sharing statement initially provided
Help: Data sharing statement date
12/01/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a 3-week lower limb pressotherapy program on selected morphological, rheological and biochemical blood parameters in young, physically active females.
Scientific title
The effect of lower limb pressotherapy on selected morphological, rheological and biochemical blood parameters in young, physically active girls – a randomized controlled trial
Additional trial identifiers [1] 315515 0
None
Universal Trial Number (UTN)
Trial acronym
PRESS-GIRLS
Related trial records

Health condition
Health condition(s) studied:
Circulatory and recovery support in healthy athletes 339105 0
Condition category
Condition code
Physical Medicine / Rehabilitation 335392 335392 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants will be randomised into two parallel groups.
The experimental group will receive lower-limb pneumatic compression therapy (pressotherapy) using an 8-chamber CARE Pump device. The device will be applied to both lower limbs. Each session will last 30 minutes, once daily, Monday to Friday, for 3 consecutive weeks.

Pressure: 60–90 mmHg, applied in a sequential distal-to-proximal compression pattern.
Sequence: manufacturer’s standard recovery program (graduated, wave-type sequence).
Administration: The device will be applied and supervised on site by a trained study physiotherapist.
Adherence monitoring: attendance logs and device session data (built-in usage counter). Participants will be asked to report any missed sessions or discomfort in a short diary.
Intervention code [1] 332135 0
Rehabilitation
Intervention code [2] 332564 0
Treatment: Devices
Description of the comparator or control
No pneumatic compression (control). Participants maintain usual routines and receive no pressotherapy. They undergo the same assessments (venous blood tests for morphology, hemorheology and biochemistry; skin condition measures; subjective recovery questionnaire) at baseline, end of week 3, and 10-day follow-up.
Control group
Active

Outcomes
Primary outcome [1] 343536 0
Changes in morphological blood parameters (RBC, HGB, HCT, MCV, MCH, MCHC, WBC, PLT).
Timepoint [1] 343536 0
Baseline (Day 0), end of intervention (Day 21), and follow-up (Day 31).
Primary outcome [2] 343537 0
Changes in hemorheological parameters (plasma viscosity, RBC deformability, RBC aggregation).
Timepoint [2] 343537 0
Baseline (Day 0), end of intervention (Day 21), and follow-up (Day 31).
Secondary outcome [1] 454738 0
Composite changes in skin condition parameters including skin hydration, skin elasticity, skin temperature, and local microcirculation
Timepoint [1] 454738 0
Baseline (Day 0), end of intervention (Day 21), and follow-up (Day 31).
Secondary outcome [2] 454739 0
Composite subjective outcome including perception of recovery and perception of leg condition
Timepoint [2] 454739 0
Baseline (Day 0), end of intervention (day 21), and follow - up (day31)

Eligibility
Key inclusion criteria
Female participants aged 14–20 years; members of the Cheerleaders Unique sports club; physically active (regular training); good general health with no acute or chronic diseases reported; written informed consent from participants and, if under 18, from parents/guardians.
Minimum age
14 Years
Maximum age
20 Years
Sex
Females
Healthy volunteers
Yes
Key exclusion criteria
Cardiovascular diseases (e.g., venous insufficiency, arterial disease, heart disease); diagnosed hematological or coagulation disorders; acute or chronic infections; neurological or musculoskeletal conditions preventing safe participation; skin diseases or open wounds on the lower limbs; use of medications influencing blood rheology or biochemical markers (e.g., anticoagulants, corticosteroids); previous or current use of pneumatic compression therapy; lack of informed consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation – sequence generated using a computer-based random number generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to summarise baseline characteristics. Between-group comparisons will be performed using repeated measures ANOVA or equivalent non-parametric tests where assumptions are not met. Significance will be set at p < 0.05. Data will be analysed using statistical software (e.g., SPSS).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/01/2026
Actual
Date of last participant enrolment
Anticipated
9/02/2026
Actual
Date of last data collection
Anticipated
20/02/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 27417 0
Poland
State/province [1] 27417 0

Funding & Sponsors
Funding source category [1] 320108 0
University
Name [1] 320108 0
University of Physical Education in Krakow, Bronislaw Czech Academy of Physical Education
Country [1] 320108 0
Poland
Primary sponsor type
University
Name
University of Physical Education in Krakow, Bronislaw Czech Academy of Physical Education
Address
Country
Poland
Secondary sponsor category [1] 322668 0
Individual
Name [1] 322668 0
Monika Dziedzic Academy of Physical Education Bronislaw Czecha in Krakow
Address [1] 322668 0
Country [1] 322668 0
Poland
Other collaborator category [1] 283701 0
Other
Name [1] 283701 0
Cheerleaders Unique
Address [1] 283701 0
Country [1] 283701 0
Poland

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318661 0
Komisja Bioetyczna przy Okregowej Izbie Lekarskiej w Krakowie
Ethics committee address [1] 318661 0
Ethics committee country [1] 318661 0
Poland
Date submitted for ethics approval [1] 318661 0
24/11/2025
Approval date [1] 318661 0
Ethics approval number [1] 318661 0

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

Contacts
Principal investigator
Name 144842 0
Ms Monika Dziedzic
Address 144842 0
Bronislaw Czech Academy of Physical Culture in Kraków, Faculty of Rehabilitation, al. Jana Pawla II 78, 31-571
Country 144842 0
Poland
Phone 144842 0
+48 729 031 702
Fax 144842 0
Email 144842 0
[email protected]
Contact person for public queries
Name 144843 0
Monika Dziedzic
Address 144843 0
Bronislaw Czech Academy of Physical Culture in Kraków, Faculty of Rehabilitation, al. Jana Pawla II 78, 31-571
Country 144843 0
Poland
Phone 144843 0
+48 729031702
Fax 144843 0
Email 144843 0
[email protected]
Contact person for scientific queries
Name 144844 0
Monika Dziedzic
Address 144844 0
Bronislaw Czech Academy of Physical Culture in Kraków, Faculty of Rehabilitation, al. Jana Pawla II 78, 31-571
Country 144844 0
Poland
Phone 144844 0
+48 12 683 10 00
Fax 144844 0
Email 144844 0
[email protected]

Data sharing statement
Will the study consider sharing 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.