MedPath

Impact of Pilates Method on Myofascial Stiffness, Cardiorespiratory Fitness and Quality of Life in Breast Cancer Women

Not Applicable
Completed
Conditions
Breast Cancer Female
Interventions
Behavioral: supervised physical activity intervention using the Pilates Method (exercises on the mat)
Registration Number
NCT06419023
Lead Sponsor
Poznan University of Physical Education
Brief Summary

The effectiveness of breast cancer treatment is quite well documented. Still, side effects can underpin other treatment-induced diseases such as osteopenia, diabetes, and especially cardiovascular dysfunction. Therefore, finding a method that could partly counteract these side effects and at the same time be implemented throughout treatment is a challenge for researchers.

The main purpose of this experimental, randomized control trial was to analyze the effect of the Pilates Method (PM) intervention on changing the myofascial stiffness along the thoracic and lumbar spine, cardiorespiratory fitness and quality of life in women with breast cancer receiving aromatase inhibitor therapy. The apllied procedure of 12 -week PM training included the training intervention based on hypothesis:

* PM reduces myofascial stiffness along the thoracic and lumbar spine of women with breast cancer receiving aromatase inhibitor therapy

* PM improves the cardiorespiratory fitness of women with breast cancer receiving aromatase inhibitor therapy

* PM improves the quality of life of women with breast cancer receiving aromatase inhibitor therapy.

Possible practical applications include the domains of exercise medicine, physical activity in cancer and public health.

Detailed Description

The trial was conducted by Poznan University of Physical Education in cooperation with UMP (Poland).

This design of trial assumed the parallel two-arm group, prospective, randomized controlled trial (RCT) comparing an exercises-based intervention (experimental group) to usual care and physical activity recommendation (control group) in women with breast cancer with perioperative hormonal treatment AI.Randomization were performed as a simple randomization with a 1:1 allocation (coin toss).

All patients were assessed and recruited by two oncologists regarding eligibility to participate in the study.

Before enrollment, all participants were given detailed information about experiment, procedures, risks, and benefits of the study and gave their written consent to participation. The patients were informed at any stage of the project may resign from participation without having to give a reason.The study was conducted in two stages. Patient recruitment and data collection started in February 2022. The baseline assessment of patients is carried out two weeks before the start of PT intervention. PT intervention lasted 12 weeks. Post-intervention assessment is performed during two weeks after PT intervention. Finally data (reports) collection and data preparation for analysis were completed in December 2023.

Potential patients matching primary criteria underwent clinical, laboratory, EKG and echocardiographic follow-up assessment by cardiologist. Clinical specialists eligible for the study provided information about the study and presented informed consent to patients. The patients were referred for further study diagnostics after clinical qualification and signed written informed consent to the planned research.

Together with oncologists the research group also included sports physiologists, cardiologist, certified Pilates teacher. All participants were evaluated by same qualified personnel according to standardized test protocols and in the same conditions at baseline and after 12-week intervention. Objective physical measurements were performed by trained and blinded assessors unaware of the assignment information.

At the baseline and post training period were performed following assessments:

* anthropometrics using digital stadiometer

* body composition tested by the dual X-ray absorptiometry method

* bone mineral density tested by the dual X-ray absorptiometry method

* questionnaire assessment of: (i) quality of life using EORTC QLQ-C30 Questionnaire version 3.0, EORTC QLQ-BR23 Questionnaire Breast cancer module), (ii) pain using Brief Pain Inventory Short Form Questionnaire), (iii) level of physical activity using IPAQ Questionnaire

* myofascial stiffness using myotonometr and a non-invasive shear-wave elastography examination

* respiratory function measured with spirometric tests

* cardiorespiratory fitness measured with: (i) cardiopulmonary exercise test CPET on the treadmil, (ii) metabolic response assessment with blood lactic acid concentration, (iii) subjective rating of perceived exertion with the Borg 6-20 scale

* vascular circulation indicators measured with the use of the Flow Mediated Skin Fluorescence

* inflammatory hematological ratios were calculated based on hematological medical patients indicators.

Patients characteristics has been completed by medical records and socio-demographic questionnaires.

The supervised physical activity intervention using the Pilates Method (60min each session, 2 sessions each week over 12 weeks) was used in this study.

In the study took part two groups - Exercise Group (experimental group performing PM intervention) and Usual-Care Group (control group).

The training program involved exercise performed on mats. The subjects took part in a model training session, during which all exercises were explained, performance was discussed, common mistakes were pointed out, and efforts were made to maintain proper exercise intensity and muscle activation and relaxation.The model PM training sessions was consisted of:

1. warm-up and respiratory exercises (5-10 min);

2. mat Pilates exercises with the traditional Pilates repertoire (basic, beginner) adapted for breast cancer patients needs and restrictions (40 min);

3. cool down and endings exercises (5 min);

4. session summary (2-3min). The training program was supervised by the same specialist of PM.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
44
Inclusion Criteria
  1. women with invasive breast cancer
  2. stage of disease according to TNM classification I-III
  3. cancer with estrogen receptor expression in at least 10% of cell nuclei
  4. supplemental hormone therapy with an aromatase inhibitor used for at least 6 months
  5. performance status according to ECOG classification 0-1
  6. BMI of 18.5-30
  7. without chronic diseases affecting the limitation of the use of oncological treatment
  8. without contraindications to participation in group supervised Pilates classes
  9. participation in at least 17 of 24 classes according to the proposed schedule
Exclusion Criteria
  1. invasive breast cancer stage IV according to TNM classification
  2. performance status according to ECOG classification 2-4
  3. unregulated hypertension
  4. unstable ischemic heart disease
  5. arrhythmia
  6. rheumatic diseases
  7. osteoporosis
  8. advanced osteoarthritis
  9. disease of rheumatic origin (AS, RA, fibromyalgia)
  10. pregnancy
  11. BMI < 18.5 or above 30
  12. unregulated hypothyroidism/hyperthyroidism

Criteria for drop out The criteria for discontinuing allocated interventions are as follows: 1) participant's voluntary withdrawal from the study; 2) worsening of oncological prognosis that prevents the continuation; 3) absence of training sessions due to unjustified reasons in the case of the PG (compliance below 70%).

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Exercises group (EG)supervised physical activity intervention using the Pilates Method (exercises on the mat)The exercise group (EG) participated in supervised physical activity intervention using the Pilates Method (exercises on the mat, 60min each session, 2 sessions each week over 12 weeks) were administered by certified Pilates teacher.
Primary Outcome Measures
NameTimeMethod
Quality of life - Global Health Statusbefore and after 12-week intervention

Quality of life - Global Health Status (GHS) assessment with EORTC QLQ-C30 Questionnaire version 3.0. On the scale minimum value is 1, maximum value is 7. A high score represents a high QoL (better outcome).

Quality of life - Functional scoresbefore and after 12-week intervention

Quality of life - Functional scores assessment with EORTC QLQ-C30 Questionnaire version 3.0.

On the scale minimum value is 1, maximum value is 4. A high score represents a high /healthy level of functioning (better outcome).

Quality of life - Symptom scoresbefore and after 12-week intervention

Quality of life - Functional scores assessment with EORTC QLQ-C30 Questionnaire version 3.0.

On the scale minimum value is 1, maximum value is 4. A high score for a symptom scale represents a high level of symptomatology /problems (worse outcome).

Quality of life - Functional scores (body image, sexual functioning, sexual enjoyment, future perspective)before and after 12-week intervention

Quality of life - Functional scores (body image, sexual functioning, sexual enjoyment, future perspective) assessment with EORTC QLQ-BR23 Questionnaire (Breast cancer module). On the scale minimum value is 1, maximum value is 4. A high score represents a high /healthy level of functioning (better outcome).

Quality of life - Symptom scores (systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss)before and after 12-week intervention

Quality of life - Symptom scores (systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss) assessment with EORTC QLQ-BR23 Questionnaire (Breast cancer module).On the scale minimum value is 1, maximum value is 4. A high score for a symptom scale represents a high level of symptomatology / problems (worse outcome).

Subjective pain assessment - Pain Interference Total Score, Physical Interference, Affective Interferencebefore and after 12-week intervention

Pain Interference Total Score, Physical Interference, Affective Interference assessment with Brief Pain Inventory (short form) Questionnaire. The seven interference items (sleep disturbance, general activity, mood, work, relations with others, walking, and enjoyment of life) are assessed on a 0 to 10 scale, with 0 being "did not interfere" and 10 being "interfered completely".

Subjective pain assessment - the extent of pain complaintsbefore and after 12-week intervention

The extent of pain complaints assessment with Brief Pain Inventory (short form) Questionnaire. Pointing out on the body diagram the places where the subject feels pain.

Subjective pain assessment - Pain Severity Total Scorebefore and after 12-week intervention

Pain Severity Total Score assessment with Brief Pain Inventory (short form) Questionnaire. Pain severity is measured by four items: worst pain, least pain, average pain in the last 24 h, and pain now. On the scale minimum value is 0 (no pain), maximum value is 10 (pain as as you can imagine).

Myofascial stiffnessbefore and after 12-week intervention

Assessment of myofascial stiffness (kPa) and (m/s) using a non-invasive shear-wave elastography examination AIXPLORER SuperSonic Imagine.

Resting Vital Capacitybefore and after 12-week intervention

Level of Resting Vital Capacity (l). Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany.

Forced Vital Capacitybefore and after 12-week intervention

Level of Forced Vital Capacity (l). Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany.

Maximal Voluntary Ventilationbefore and after 12-week intervention

Maximal Voluntary Ventilation (l/min). Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany.

Forced Expiratory Volume in the first second of expirationbefore and after 12-week intervention

Forced Expiratory Volume in the first second of expiration in %. Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany.

Peak Expiratory Flowbefore and after 12-week intervention

Peak Expiratory Flow (l/s). Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany

The modified Tiffeneau-Pinelli indexbefore and after 12-week intervention

The modified Tiffeneau-Pinelli index is Forced Expiratory Volume in 1 second/ Vital Capacity ratio (%). A ratio below 70% is typically indicative of obstructive lung disease. Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany.

absolute Oxygen Uptakebefore and after 12-week intervention

Absolute Oxygen Uptake (l/min) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

relative Oxygen Uptakebefore and after 12-week intervention

Relative Oxygen Uptake (l/min/kg) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

Volume of carbon dioxidebefore and after 12-week intervention

Volume of carbon dioxide (l/min) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

relative Power Outputbefore and after 12-week intervention

Relative Power Output (W/kg) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP), at maximal/peak oxygen uptake. Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

absolute Power Outputbefore and after 12-week intervention

Absolute Power Output (Watts) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP), at maximal/peak oxygen uptake. Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

Ventilatory equivalent for carbon dioxidebefore and after 12-week intervention

Ventilatory equivalent for carbon dioxide (l/min) Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

Power Output when respiratory ratio (RQ) equal 1before and after 12-week intervention

Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

Minute ventilation per carbon dioxide production VE/VCO2 slopebefore and after 12-week intervention

Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

Heart Ratebefore and after 12-week intervention

Resting and maximal Heart Rate (beats/min). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while an walking test on the treadmill using a heart rate monitor.

Blood Lactic Acid Concentrationbefore and after 12-week intervention

Metabolic response assessment with blood lactic acid concentration (mmol/l) are tasted before and after a cardiopulmonary exercise test (CPET) (Biosen C-line, EKF Diagnostics)

Subjective rating of perceived exertionbefore and after 12-week intervention

Borg 6-20 scale was applied to indicate the level of exertion by participant at maximal oxygen uptake /peak oxygen uptake workload during CPET. On the scale minimum value is 6 (no exertion at all), maximum value is 20 (maximal exertion).

Secondary Outcome Measures
NameTimeMethod
Body Heightbefore and after 12-week intervention

Body Height (m) is measured using Digital stadiometer (Seca 285, SECA, Hamburg, Germany).

Body Massbefore and after 12-week intervention

Body Mass (kg) is measured using Digital stadiometer (Seca 285, SECA, Hamburg, Germany).

Total Body Massbefore and after 12-week intervention, test conducted while fasting

Total Body Mass (kg). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).

Bone Massbefore and after 12-week intervention, test conducted while fasting

Bone Mass (kg). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).

Muscle Massbefore and after 12-week intervention, test conducted while fasting

Muscle Mass (kg). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).

Skeletal Muscle Massbefore and after 12-week intervention, test conducted while fasting

Skeletal Muscle Mass (kg). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).

Fat Massbefore and after 12-week intervention, test conducted while fasting

Fat Mass (kg). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).

Visceral Adipose Tissue 2before and after 12-week intervention, test conducted while fasting

Visceral Adipose Tissue (g). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).

Relative Skeletal Muscle Mass Indexbefore and after 12-week intervention, test conducted while fasting

Relative Skeletal Muscle Mass Index (RSMI) (kg/m\^2). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).

Intra-Cellular Waterbefore and after 12-week intervention, test conducted while fasting

Intra-Cellular Water (kg). Body water component measured using TANITA MC-98OMA plus device.

Total Body Waterbefore and after 12-week intervention, test conducted while fasting

Total Body Water (kg). Body water component measured using TANITA MC-98OMA plus device.using TANITA MC-98OMA plus device.

Bone Mineral Densitybefore and after 12-week intervention, test conducted while fasting

Bone Mineral Density (g/cm\^2). Indicators of bone mineral density are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).

Lean Body Massbefore and after 12-week intervention, test conducted while fasting

Lean Body Mass (kg). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).

Fat-Free Massbefore and after 12-week intervention, test conducted while fasting

Fat-Free Mass (kg). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).

Visceral Adipose Tissue 1before and after 12-week intervention, test conducted while fasting

Visceral Adipose Tissue (cm\^3). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).

Body Mass Indexbefore and after 12-week intervention, test conducted while fasting

Body Mass Index (BMI) (kg/m\^2). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).

Extra-Cellular Waterbefore and after 12-week intervention, test conducted while fasting

Extra-Cellular Water (kg). Body water component measured using TANITA MC-98OMA plus device.

Bone Mass Componentbefore and after 12-week intervention, test conducted while fasting

Bone Mass Component (kg). Indicator is tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).

T-Scorebefore and after 12-week intervention, test conducted while fasting

T-Score Index. Indicators of bone mineral density are tested and calculated by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).

Z-Scorebefore and after 12-week intervention, test conducted while fasting

Z-Score Index. Indicators of bone mineral density are tested and calculated by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).

Inflammatory hematological ratiosbefore and after 12-week intervention

Indicators of inflammation (Neutrophil to Lymphocyte ratio, Monocyte to Lymphocyte ratio, Platelet to Lymphocyte ratio) are calculated made based on hematological medical records.

Level of Physical activitybefore and after 12-week intervention

A self-report scale that measures physical activity. The IPAQ comprises 27 items that assess time spent engaging in various levels of physical activity and includes sitting time. Participants are asked to report their responses in terms of minutes, hours, or days. The units of measurement are METs min/week. The amount of physical activity is assessed based on intensity (moderate, intense, walking), and the amount of total physical activity is calculated by summing up the records across each dimension by intensity. A category of low physical activity is considered a result in the total physical activity below 600 METs min/week, moderate between 600 and 3000 METs min/week and high above 3000 METs min/week. Scores can be computed continuously or categorically.

Oxygen Pulsebefore and after 12-week intervention

Oxygen Pulse (ml). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

Breathing Frequencybefore and after 12-week intervention

Breathing Frequency (breaths/min). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

Respiratory Exchange Ratiobefore and after 12-week intervention

Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

Ventilatory Efficiencybefore and after 12-week intervention

Ventilatory Efficiency (l/min) Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

Tidal Volumebefore and after 12-week intervention

Tidal Volume (l) Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

Speedbefore and after 12-week intervention

Speed (km/h). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

Distancebefore and after 12-week intervention

Distance (m) Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany).

Indicators of vascular circulationbaseline (before and immediately after CPET) and after 12-week intervention (before and immediately after CPET)

Vascular circulation indicators (Reactive Hyperemia Response, Hypoxia Sensitivity, Normoxia Oscillatory Index, the rate of Nicotinamide Adenine Dinucleotide fluorescence growth) are measured with the use of the Flow Mediated Skin Fluorescence (FMSF) using The AngioExpert device (AngioExpert, Poland).

Trial Locations

Locations (1)

Poznan University of Physical Education

🇵🇱

Poznan, Wielkopolskie, Poland

© Copyright 2025. All Rights Reserved by MedPath