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Trial registered on ANZCTR


Registration number
ACTRN12622000734763
Ethics application status
Approved
Date submitted
3/04/2022
Date registered
23/05/2022
Date last updated
26/04/2023
Date data sharing statement initially provided
23/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Influence of interval training combined with occlusion and cooling on selected blood parameters, muscle metabolism and indicators of oxidative stress.
Scientific title
Influence of interval training combined with occlusion and cooling on red blood cell deformability and aggregability, coagulology parameters, muscle metabolism (lactate, myoglobin, cortisol) and indicators of oxidative stress (TAS, TOS, MDA, XO) in healthy adults aged 20 to 25
Secondary ID [1] 306828 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
metabolic myopathies 325913 0
oxidative stress 325914 0
Condition category
Condition code
Physical Medicine / Rehabilitation 323228 323228 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
30 young, healthy people will take part in the study. They will be divided into 2 research groups: 2 intervention groups. Participants will be recruited through an advertisement posted at the University of Physical Education in Krakow. Allocation of individuals to different groups will be made by sampling volunteers. The subjects will be included in the research program after obtaining the consent of a rehabilitation physician and after consulting a physiotherapist (assessment of health and functional status).

The research will cover a group of 30 people:
1. 15 people Vasper Systems LLC training with the use of occlusion - interval effort consisting of 3 intervals of 6 minutes with maintaining an individually selected level of heart rate and 60 seconds of rest between intervals (about 20 minutes).
2. 15 people Vasper Systems LLC training with the use of occlusion and cooling - test scheme as in point 1 combined with a continuous cooling system provided by the cuffs used in the occlusion and cooling mats placed under the feet and in the sitting area.

Participants will be asked to alternate limb movements for 3 intervals of 6 minutes with individually adjusted heart rate and 60 seconds of rest between intervals, with calf and arm cuffs on. The pressure in the cuffs will be increased during the activity to limit blood flow to the legs and arms.

For both study groups:
the method of administering the interval training: one on one (individual training)
individually selected heart rate in consultation with a physiotherapist - lactate level test
training room temperature of 20 degrees Celsius
the cuffs temperature of 10 degrees Celsius
frequency and duration of sessions: 20-minute sessions three times a week
total duration of the intervention is approximately 10 weeks
strategies used to assess or monitor adherence to the intervention: session attendance checklists (100% attendance mandatory)
random assignment to groups
Intervention code [1] 323293 0
Treatment: Other
Intervention code [2] 323434 0
Treatment: Devices
Comparator / control treatment
group 1 will be the control group (no occlusion, no cooling)

15 people Vasper Systems LLC training without occlusion - interval effort consisting of 3 intervals of 6 minutes with maintaining an individually selected level of heart rate and 60 seconds of rest between intervals (about 20 minutes).
Control group
Active

Outcomes
Primary outcome [1] 330976 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] 330976 0
Study 1: 2 weeks before training
Study 2: on the day training begins
Study 3: 24h after 1 training session
Study 4: 24h after 10th training
Study 5: 24h after 20 training (primary endpoint)
Study 6: follow-up 2 weeks after the last training session
Primary outcome [2] 330977 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 [2] 330977 0
Study 1: 2 weeks before training
Study 2: on the day training begins
Study 3: 24h after 1 training session
Study 4: 24h after 10th training
Study 5: 24h after 20 training (primary endpoint)
Study 6: follow-up 2 weeks after the last training session
Primary outcome [3] 330978 0
Assessment of the change coagulology: prothrombin activity [%], INR [INR], APTT [sec.], TT [sec.], Fibrinogen [g / l], D-Dimer [ng / ml] (blood sample)
Timepoint [3] 330978 0
Study 1: 2 weeks before training
Study 2: on the day training begins
Study 3: 24h after 1 training session
Study 4: 24h after 10th training
Study 5: 24h after 20 training (primary endpoint)
Study 6: follow-up 2 weeks after the last training session
Secondary outcome [1] 408325 0
VEGF - vascular endothelial growth factor [pg/ml] assessed by serum sample
Timepoint [1] 408325 0
Study 1: 2 weeks before training
Study 2: on the day training begins
Study 3: 24h after 1 training session
Study 4: 24h after 10th training
Study 5: 24h after 20 training
Study 6: follow-up 2 weeks after the last training session
Secondary outcome [2] 409565 0
IGF-1 - insulin-like growth factor-1 [pg/ml] assessed by serum sample
Timepoint [2] 409565 0
Study 1: 2 weeks before training
Study 2: on the day training begins
Study 3: 24h after 1 training session
Study 4: 24h after 10th training
Study 5: 24h after 20 training
Study 6: follow-up 2 weeks after the last training session
Secondary outcome [3] 409566 0
GF - growth factor [pg/ml] assessed by serum sample
Timepoint [3] 409566 0
Study 1: 2 weeks before training
Study 2: on the day training begins
Study 3: 24h after 1 training session
Study 4: 24h after 10th training
Study 5: 24h after 20 training
Study 6: follow-up 2 weeks after the last training session
Secondary outcome [4] 409896 0
oxidative stress: (TAS [µmol / l], TOS [µmol / l], MDA [µmol / l], XO [µmol / l]) assessed by serum sample
Timepoint [4] 409896 0
Study 1: 2 weeks before training
Study 2: on the day training begins
Study 3: 24h after 1 training session
Study 4: 24h after 10th training
Study 5: 24h after 20 training
Study 6: follow-up 2 weeks after the last training session
Secondary outcome [5] 409897 0
myoglobin [µg / l] assessed by serum sample
Timepoint [5] 409897 0
Study 1: 2 weeks before training
Study 2: on the day training begins
Study 3: 24h after 1 training session
Study 4: 24h after 10th training
Study 5: 24h after 20 training
Study 6: follow-up 2 weeks after the last training session
Secondary outcome [6] 409898 0
cortisol [µg / dl] assessed by serum sample
Timepoint [6] 409898 0
Study 1: 2 weeks before training
Study 2: on the day training begins
Study 3: 24h after 1 training session
Study 4: 24h after 10th training
Study 5: 24h after 20 training
Study 6: follow-up 2 weeks after the last training session

Eligibility
Key inclusion criteria
• age: 20-25 years,
• no contraindications to participate in training with the use of occlusion and cooling,
• written informed consent to participate in research,
• people not involved in regular physical training.
Minimum age
20 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• hypertension,
• Heart arythmia,
• heart failure,
• diabetes,
• acute systemic diseases,
• active neoplastic disease or a period of 5 years from the end of treatment,
• kidney failure,
• changing the diet immediately before or during the project,
• participation in regular (professional) sports training directly before or during the project.

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
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
30/05/2022
Actual
30/05/2022
Date of last participant enrolment
Anticipated
Actual
1/08/2022
Date of last data collection
Anticipated
Actual
30/09/2022
Sample size
Target
45
Accrual to date
Final
45
Recruitment outside Australia
Country [1] 24706 0
Poland
State/province [1] 24706 0
Malopolska

Funding & Sponsors
Funding source category [1] 311160 0
University
Name [1] 311160 0
University of Physical Education in Cracow
Country [1] 311160 0
Poland
Primary sponsor type
Individual
Name
Bartlomiej Ptaszek Ph.D.
Address
University of Physical Education in Cracow
Institute of Applied Sciences
Department of Physical Medicine and Biomedical Renewal

al. Jana Pawla II 78
Kraków
Post code: 31-571
Poland
Country
Poland
Secondary sponsor category [1] 312514 0
Individual
Name [1] 312514 0
Szymon Podsiadlo Ph.D.
Address [1] 312514 0
University of Physical Education in Cracow
Institute of Clinical Rehabilitation
Department of Rehabilitation in Traumatology

al. Jana Pawla II 78
Kraków
Post code: 31-571
Poland
Country [1] 312514 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310687 0
Bioethical Commission of the Regional Medical Chamber in Krakow
Ethics committee address [1] 310687 0
Ethics committee country [1] 310687 0
Poland
Date submitted for ethics approval [1] 310687 0
Approval date [1] 310687 0
11/06/2021
Ethics approval number [1] 310687 0
164/KBL/OIL/2021

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

Contacts
Principal investigator
Name 118522 0
Dr Bartlomiej Ptaszek
Address 118522 0
Department of Physical Medicine and Biomedical Renewal
Institute of Applied Sciences
University of Physical Education in Krakow, Poland
Jana Pawla II 78 Kraków Post code: 31-571 Poland
Country 118522 0
Poland
Phone 118522 0
+48 698914837
Fax 118522 0
Email 118522 0
bartlomiej.ptaszek@awf.krakow.pl
Contact person for public queries
Name 118523 0
Bartlomiej Ptaszek
Address 118523 0
Department of Physical Medicine and Biomedical Renewal
Institute of Applied Sciences
University of Physical Education in Krakow, Poland
Jana Pawla II 78 Kraków Post code: 31-571 Poland
Country 118523 0
Poland
Phone 118523 0
+48 698914837
Fax 118523 0
Email 118523 0
bartlomiej.ptaszek@awf.krakow.pl
Contact person for scientific queries
Name 118524 0
Bartlomiej Ptaszek
Address 118524 0
Department of Physical Medicine and Biomedical Renewal
Institute of Applied Sciences
University of Physical Education in Krakow, Poland
Jana Pawla II 78 Kraków Post code: 31-571 Poland
Country 118524 0
Poland
Phone 118524 0
+48 698914837
Fax 118524 0
Email 118524 0
bartlomiej.ptaszek@awf.krakow.pl

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
Dimensions AIThe Influence of Interval Training Combined with Occlusion and Cooling on Selected Indicators of Blood, Muscle Metabolism and Oxidative Stress2023https://doi.org/10.3390/jcm12247636
N.B. These documents automatically identified may not have been verified by the study sponsor.