ANZCTR - Registration

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]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

metabolic myopathies

oxidative stress

Condition category

Condition code

Physical Medicine / Rehabilitation

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]

Treatment: Other

Intervention code [2]

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]

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]

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]

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]

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]

Assessment of the change coagulology: prothrombin activity [%], INR [INR], APTT [sec.], TT [sec.], Fibrinogen [g / l], D-Dimer [ng / ml] (blood sample)

Timepoint [3]

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]

VEGF - vascular endothelial growth factor [pg/ml] assessed by serum sample

Timepoint [1]