Physical Activity and Disability Prevention in Postmenopausal Women

Not Applicable

Active, not recruiting

• Conditions: Metabolic Syndrome; Fall Risk; Sarcopenia in Elderly; Osteopenia, Osteoporosis; Cardiovascular Diseases; Dementia; Quality of Life Outcomes; Cognitive Ability, General

• Registration Number: NCT06781541
• Lead Sponsor: Gdansk University of Physical Education and Sport

Brief Summary

The aim of this clinical study is to examine the impact of physical activity on the physical and mental health of postmenopausal women, with a particular focus on the development of disability. The main questions this study aims to answer are:

1. Can physical activity programs (Nordic walking, Bungy Pump, strength training, functional general conditioning training) prevent loss of mobility, bone density and urinary incontinence, reduce the risk of falls, lower metabolic syndrome parameters, and improve cardiovascular endurance in postmenopausal women?

2. Do regular exercises improve cognitive functions, motivation, memory, visual coordination, mood, and quality of life in postmenopausal women?

Researchers will compare the test groups (Nordic Walking, Bungy Pump, strength training, functional general conditioning training) with the control group to determine whether physical activity brings benefits in terms of physical and mental health compared to no intervention.

Participants will:

Take part in a three-month physical activity program that includes Nordic walking, Bungy Pump exercises, functional general conditioning training and strength training, depending on the group.

The control group will not participate in any additional physical exercise program and will continue with their usual daily activities.

Detailed Description

This study will involve two testing phases (pre- and post-training). Prior to the first test, participants' physical activity will be measured over a period of seven days using POLAR accelerometers to evaluate the relationship between their daily physical activity and health. Each testing phase will last two days; on the first day, blood samples will be collected, and preliminary analyses of body composition and dietary records will be conducted. On the second day, physical fitness tests and psychological test swill be performed at the AWFiS Sports Exercise Laboratory in Gdańsk. Biological materials (serum) will be frozen and subsequently tested by contractors at the AWFiS Sports Genetics Laboratory. Participants will be required to maintain a dietary diary to record their dietary intake for the three days preceding the tests.

Study Timeline

• Study Start: 2022-02-21
• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Primary Completion: 2025-10-05
• Study Completion: 2025-10-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

• Postmenopausal women over 60 years old (i.e. more than 12 months since their last menstrual cycle).

There were no contraindications to exercise after case reports and initial diagnosis.

Informed consent must be signed, agreeing to participate in research and physical exercise programs.

Exclusion Criteria

• Uncontrolled high blood pressure. Rheumatoid arthritis. Type 2 diabetes. Are taking or have used antibiotics and/or antifungal therapy in the past 4 weeks.

Unwillingness to stick to a prescribed schedule.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Low Density Lipoprotein Cholesterol (LDL-C)	From enrollment to the end of treatment at 3 months	Low-density lipoprotein cholesterol (LDL-C) is the main lipoprotein in fasting plasma. The content of LDL-C is related to the incidence and degree of cardiovascular disease, and is considered to be the main causative factor of atherosclerosis. LDL-C is measured in mg/dl. Fasting venous blood samples will be collected after at least 12 hours of overnight stay. Blood will be collected in a Sarstedt S-Monovette tube without anticoagulants, but with the addition of coagulation factors to obtain serum. Serum samples will be processed according to standard laboratory procedures, aliquoted and stored at -80°C until analysis. Blood tests will be carried out by an external company.
Fasting blood glucose (FBG)	From enrollment to the end of treatment at 3 months	Fasting blood glucose (FBG) refers to the blood glucose value detected by the plasma collected before breakfast after fasting overnight (at least 8\~10 hours without eating any food, except drinking water), which can reflect the function of pancreatic B cells, generally indicate the secretion function of basal insulin, and is the most commonly used detection index for diabetes. The unit of FBG is: mg/dl. Fasting venous blood samples will be collected after at least 12 hours of overnight stay. Blood will be collected in a Sarstedt S-Monovette tube without anticoagulants, but with the addition of coagulation factors to obtain serum. Serum samples will be processed according to standard laboratory procedures, aliquoted and stored at -80°C until analysis. Blood tests will be carried out by an external company.
Gait Speed	From enrollment to the end of treatment at 2 weeks	In order to harmonize the pace measurement method, the 2019 Asian Sarcopenia Working Group recommends the time it takes to walk 6 meters at a normal pace from moving as a measure of average pace. The test is carried out in an inspection room that is more than 8 meters long. Crutches that participants normally use can also be used. The start and end of the 6-meter distance are clearly marked. Subjects stand with their toes touching the starting line, and after being instructed to move forward at their usual speed, subjects start walking, inspectors start timing, and when subjects fully cross the 6-meter mark with one foot, inspectors stop timing. The test is performed twice, recording the shortest time (in seconds) required to complete each distance. The smaller the value, the faster the walking speed, the better the physical ability.
Skeletal muscle index	From enrollment to the end of treatment at 2 weeks	SMI in InBody is calculated as follows: SMI= sum of segmental muscle mass (two arms and two legs) ÷ height 2
Cognitive Abilities Assessment	From enrollment to the end of treatment at 3 months	The study was conducted in a controlled laboratory using the Vienna Test System (VTS) with the Kognitron (COG) test to assess cognitive abilities. The participant, seated at a computer, performed tasks measuring working memory, attention, problem-solving, and decision-making. Clear instructions and a brief training phase ensured understanding of the tasks. The system recorded performance metrics such as reaction time and accuracy, automatically processing data to ensure objectivity. Test duration varied from several minutes to an hour, with detailed reports generated upon completion, ensuring standardized and reliable assessment.
Quality of Life	From enrollment to the end of treatment at 3 months	The study utilized the WHOQOL-BREF questionnaire, a 26-item tool developed by the World Health Organization to assess quality of life across four domains: physical health, psychological well-being, social relationships, and environment. Participants, informed of the study's voluntary and anonymous nature, responded to statements using a Likert scale (1-5). Completing the questionnaire took 10-15 minutes, with researchers available for clarifications. Responses were analyzed per WHO guidelines, converting scores to a 0-100 scale for domain comparison. The results offer a comprehensive quality-of-life assessment, widely applicable in healthcare, psychology, and social research.
VO2max	From enrollment to the end of treatment at 3 months	The EKBLOM-BAK test is a submaximal cycle ergometry test to estimate VO2max. After calibrating the ergometer and ensuring pre-test conditions (e.g., avoiding heavy meals, alcohol, and intense activity), the participant pedals at 60 rpm for 4 minutes at a workload targeting a heart rate of 110-140 bpm. Heart rate is averaged at specific intervals. The workload is then increased, and perceived exertion (RPE) is assessed. Adjustments to resistance depend on RPE ratings, with the test stopping if RPE exceeds 17. VO2max is estimated using collected data via a formula or an online tool. Suitable for individuals aged 20-86, the test provides reliable VO2max estimates.
Gait	From enrollment to the end of treatment at 3 months	Gait analysis was conducted using the Zebris FDM-T treadmill, equipped with 10,240 force sensors (0.85 x 0.85 cm) to record reactive forces in three directions at 120 Hz. The treadmill's adjustable speed (0.2-22 km/h) enabled analysis at various paces. Participants walked barefoot, starting at 0.5 km/h with 0.3 km/h increments every 15 seconds, until determining their comfortable walking speed, followed by a 1-minute test.Spatiotemporal variability was assessed using the coefficient of variation (CV) for step length and time, with higher CV values indicating greater variability.
Static Balance	From enrollment to the end of treatment at 3 months	Center of pressure (CoP) trajectory analysis provided insights into stability and balance. Static balance assessment included CoP sway area, path length, sway rate, and pressure distribution between feet. Participants stood barefoot with specific posture and completed three 20-second trials, with 30-second breaks between each.
Pelvic Floor Muscle Function	From enrollment to the end of treatment at 3 months	The study consisted of two stages: completing the Incontinence Impact Questionnaire (IIQ) and evaluating pelvic floor muscle function using surface electromyography (sEMG) with biofeedback. In the first stage, participants completed the IIQ to assess the subjective impact of urinary incontinence on daily life. The data collected helped evaluate discomfort and limitations caused by incontinence. In the second stage, pelvic floor muscle function was assessed using sEMG with a vaginal electrode, measuring muscle activity at rest and during controlled contractions. Biofeedback training allowed participants to observe muscle activity in real time, helping improve control over pelvic floor muscle function.
Daily steps	Physical activity levels were monitored for 7 days prior to the test	Assess physical activity levels over 7 days using the POLAR accelerometer, record daily steps.
Risk of Falls	From enrollment to the end of treatment at 3 months	The Biodex Balance System (BBS) was used to assess the risk of fall test (RFT). The participants were asked to step on a platform in a bipedal stance with bare feet and open eyes looking forward to the BSS monitor to control the cursor, while their hands hung by their sides (hand support was not permitted). They were asked to stand straight, not to change their feet position, and only sway their body when necessary.; Risk of Fall Test (RFT): The assessment of the dynamic bilateral stance was conducted on an unstable platform, where levels 6 to 2 were used. The test consisted of three measurements at intervals of 20 s of testing, and a break of 10 s. Prior to testing, the test procedure was explained. In this test, only the OSI was performed. This index was calculated through the degree of oscillation of the platform, where lower scores suggested better stability of th
Bone Density	From enrollment to the end of treatment at 3 months	The densitometry test was conducted to assess the bone mineral density in women. The DEXA (dual-energy X-ray absorptiometry) technique was used, which allows precise measurements of bone mineral density. The measurement covered two key areas: the lumbar spine (L1-L4) and the femoral neck. The test involved positioning the patient on the densitometry table, where directed X-ray radiation passed through the tissues, enabling the calculation of bone mineral density in the designated areas. The entire process was painless and non-invasive, usually taking around 15-20 minutes. The participants were informed about the purpose of the test and that no special preparation was required. The results allowed for determining the bone mineral density in the selected areas, which served as the basis for assessing the risk of osteoporosis and other bone metabolic disorders.
Triglycerides (Metabolic syndrome Indicators)	From enrollment to the end of treatment at 3 months	The level of triglycerides is one of the important indicators of human health. High or low levels of triglycerides in the blood can indicate certain health problems. The unit of TG is: mg/dl. Fasting venous blood samples will be collected after at least 12 hours of overnight stay. Blood will be collected in a Sarstedt S-Monovette tube without anticoagulants, but with the addition of coagulation factors to obtain serum. Serum samples will be processed according to standard laboratory procedures, aliquoted and stored at -80°C until analysis. Blood tests will be carried out by an external company.
Total cholesterol (Metabolic syndrome Indicators)	From enrollment to the end of treatment at 3 months	Total cholesterol refers to the sum of cholesterol contained in all lipoproteins in the blood, and its serum concentration can be used as an indicator of lipid metabolism. The unit of TG is: mg/dl. Fasting venous blood samples will be collected after at least 12 hours of overnight stay. Blood will be collected in a Sarstedt S-Monovette tube without anticoagulants, but with the addition of coagulation factors to obtain serum. Serum samples will be processed according to standard laboratory procedures, aliquoted and stored at -80°C until analysis. Blood tests will be carried out by an external company.
High Density Lipoprotein Cholesterol (HDL-C)	From enrollment to the end of treatment at 3 months	High-density lipoprotein (HDL) is one of the serum proteins, which is a complex lipoprotein composed of lipids, proteins and their regulators. HDL-C is a clinical test that represents the level of HDL in the blood. The unit of HDL-C is: mg/dl. Fasting venous blood samples will be collected after at least 12 hours of overnight stay. Blood will be collected in a Sarstedt S-Monovette tube without anticoagulants, but with the addition of coagulation factors to obtain serum. Serum samples will be processed according to standard laboratory procedures, aliquoted and stored at -80°C until analysis. Blood tests will be carried out by an external company.
non-High Density Lipoprotein Cholesterol (no-HDL-C)	From enrollment to the end of treatment at 3 months	Non-high-density lipoprotein cholesterol (non-HDL-C) is the sum of cholesterol contained in lipoproteins other than HDL. Non-HDL cholesterol is a strong predictor of cardiovascular risk and can predict the progression of atherosclerosis. The unit of no-HDL-C is: mg/dl. Fasting venous blood samples will be collected after at least 12 hours of overnight stay. Blood will be collected in a Sarstedt S-Monovette tube without anticoagulants, but with the addition of coagulation factors to obtain serum. Serum samples will be processed according to standard laboratory procedures, aliquoted and stored at -80°C until analysis. Blood tests will be carried out by an external company.

Secondary Outcome Measures

Name	Time	Method
PEAK AWY	From enrollment to the end of treatment at 2 weeks	Peak knee extension muscle strength. Using Biodex System 4 Pro™ dynamometers (Biodex Medical Systems, Inc.) Data collection using Compaq Desk Pro personal computers and Biodex software, using the Biodex standard protocol. After a standardized warm-up, the subject is positioned in the equipment as required by the manufacturer's manual (sitting position, arms hanging down along the body, hands holding the outside handle, torso, buttocks and subject thighs secured by straps, knee flexion to 90°). The test uses the scheme reported by Symons et al., with some modifications. The isometric muscle strength test was performed using three maximum contractions, each lasting 5 seconds with an interval of 30 seconds. Adjust the seat position according to the length of each subject's legs. Data were analyzed using the results of the dominant lower limbs. The greater the value of this index, the stronger the isometric contraction force of the knee extensor muscle.
PEAK TWD	From enrollment to the end of treatment at 2 weeks	Peak knee flexor strength. Using Biodex System 4 Pro™ dynamometers (Biodex Medical Systems, Inc.) Data collection using Compaq Desk Pro personal computers and Biodex software, using the Biodex standard protocol. After a standardized warm-up, the subject is positioned in the equipment as required by the manufacturer's manual (sitting position, arms hanging down along the body, hands holding the outside handle, torso, buttocks and subject thighs secured by straps, knee flexion to 90°). The test uses the scheme reported by Symons et al., with some modifications. The isometric muscle strength test was performed using three maximum contractions, each lasting 5 seconds with an interval of 30 seconds. Adjust the seat position according to the length of each subject's legs. Data were analyzed using the results of the dominant lower limbs. The higher the value of this index, the stronger the isometric contraction force of knee flexor muscle.
Tandem Balance	From enrollment to the end of treatment at 2 weeks	Participants used the "toe" stick to the "heel" in a straight-line walking way, with the fastest speed to complete 2 and 5 meters. The smaller the value, the faster the walking speed, which may represent better balance ability.
Arm strength index	From enrollment to the end of treatment at 2 weeks	The arm strength HS was measured by a dynamometer, and the weight BM was measured in KG using a weight scale. Arm strength index calculation formula: HS/BM. A higher value for this indicator may mean greater muscle strength.
Skeletal Lean Mass	From enrollment to the end of treatment at 2 weeks	Using the Octupole Bioimpedance InBody 720 analyzer (Biospace, Seoul, Korea), participants wore light clothing and no shoes. The calculation method of SLM is different from that of SMM. The SLM in InBody report paper is the sum of protein, body water, and extracosseous inorganic salts. The ideal SLM for men is 80% of standard body weight and 72% of standard body weight for women. A 10% move up or down is considered normal.
Pain pressure threshold (PPT)	From enrollment to the end of treatment at 3 months	Pain pressure threshold (PPT) was assessed using the Medoc AlgoMed Seaweed Meter (Israel). PPT is the minimum pressure at which pressure turns into pain. Measurements are taken in a seated position on the back of the hand (between the thumb and forefinger) and the lateral arm (2/3 of the length of the arm). Stimulation was applied at a rate of 30 kPa/sec. When the pain is felt (PPT) measurement ends.
Electromyography	From enrollment to the end of treatment at 3 months	After evaluating basic physical characteristics, women performed maximal voluntary contractions (MVCs) for EMG normalization. MVC measurements were taken using the Biodex System 4 dynamometer (Biodex Medical Systems Inc., USA) according to the manufacturer's guidelines. Settings included: 90° flexion and abduction of the shoulder, 90° flexion of the elbow with 45° shoulder flexion, 90° flexion of the knee and hip, and a neutral wrist position with 90° elbow flexion. Skin was prepared for EMG recording following SENIAM guidelines. Electrodes were placed on the dominant side muscles. EMG signals were collected with the Noraxon TeleMyo DTS system. Raw data were processed, rectified, smoothed, and normalized to MVC peak values for each individual, with results averaged over 3 attempts.
Postural Stability Test (PST)	From enrollment to the end of treatment at 3 months	Subjects were subjected to a postural stability test (PST) using the Biodex Balance System (BBS). PST assesses postural stability using three metrics: OSI, APSI, and MLSI, with three 10-second trials on a stable platform. Higher scores indicate greater postural instability. Participants stand on the podium with their eyes wide open and their hands at their sides.
Spatial memory assessment	From enrollment to the end of treatment at 3 months	The CORSI test was conducted using the Vienna Test System (VTS) software to assess the spatial memory of women. On the screen, nine irregularly positioned blocks appear. A hand-shaped cursor points to the blocks, which briefly light up, creating a sequence. After the sequence is completed, the participant must tap the same blocks in the same order. The test starts with three-block sequences, and the length of the sequences gradually increases to eight blocks. The test ends after three failed attempts with the eight-block sequence or after 18 trials. The test result measures visual memory, and the difficulty of the sequences increases with each subsequent trial. The test was conducted in a quiet environment to ensure the participants' comfort and focus.
Global Physical Activity Questionnaire (GPAQ)	From enrollment to the end of treatment at 3 months	GPAQ involves completing a questionnaire about daily activity in three areas: work, transportation, and leisure. Participants report time spent on activities like walking, running, cycling, or physically demanding work. Responses are used to classify activity level (low, moderate, high).
Fall-related concerns	From enrollment to the end of treatment at 3 months	The assessment using the Polish version of the Short FES-I (PL) involves the participant completing 7 questions about concerns related to falls in daily activities. The questionnaire evaluates the subjective perception of fall risk in various situations, such as walking upstairs, shopping, or walking outside. Participants respond to the questions, rating how insecure they feel in each situation using a Likert scale from 1 (very secure) to 4 (very insecure). The responses are summed, which allows for determining the level of fall-related concerns. The questionnaire is quick to complete and provides information about the participant's subjective perception of fall risk.
Cognitive Ability	From enrollment to the end of treatment at 3 months	The Trail Making Test (TMT) is a tool used to assess cognitive functions, measuring the speed of information processing and cognitive flexibility. The test consists of two parts: Part A: The participant connects numbers (1-25) in ascending order by drawing a line between them. The time to complete the task is measured.; Part B: The participant alternates between connecting numbers and letters (1-A-2-B-3-C...13-L), which requires greater cognitive flexibility. The time to complete this part is also measured.; The test is conducted in a quiet, controlled environment. The participant receives clear in-structions before starting each part. The time taken for each part is measured, and the results are interpreted based on the total time. A longer time in Part B may indicate difficulties with executive functions. The test is a simple tool for assessing cognitive abilities in older adults.
30-Second Chair Stand	From enrollment to the end of treatment at 3 months	Physical Fitness Test (SFT) levels in older adults were assessed by the 30-second chair standing test. Measures lower body strength. The participant stands as many times as possible in 30 seconds. Fewer than 8 stands indicate a risk zone.
Circumferences	From enrollment to the end of treatment at 3 months	These tests provide a comprehensive assessment of an older adult's physical fitness, with spe-cific "risk zones" indicating potential areas of concern for strength, endurance, flexibility, and balance. The results help identify the need for targeted interventions or exercise programs.; Measurement of waist, hip, arm, and calf circumferences in older adults is conducted to assess body composition and monitor physical health.; Waist circumference is measured at the level of the navel, ensuring the measuring tape is ho-rizontal and fits snugly without compressing the skin. Hip circumference is measured at the widest point of the hips, with the tape kept level and not too tight.; Arm circumference is measured at the midpoint between the shoulder joint and elbow, while calf circumference is taken at the widest point of the calf, ensuring the tape is neither too loo-se nor too tight.; Measurements should be taken standing and breathing normally, with two repetitions and an average.
Forward Lean Test	From enrollment to the end of treatment at 3 months	This test evaluates the ability to maintain balance while leaning the torso forward.; Methodology: The participant stands in an upright position, with one arm extended forward, leaning against a wall. They then slowly lean their torso forward, aiming to maintain balance without touching the wall or the ground. The test is repeated three times, and the result is ba-sed on the best time the participant is able to maintain balance.; Interpretation of Results: A longer time maintaining balance indicates good postural control, while difficulties in maintaining the position may suggest balance issues.
Sedentary time	From enrollment to the end of treatment at 3 months	Description: Assess physical activity levels over 7 days using the POLAR accelerometer, record daily lying time, sitting time and standing time.Time Frame: Physical activity levels were monitored for 7 days prior to the test
Adiponectin (ADPN)	From enrollment to the end of treatment at 3 months	Adiponectin (ADPN) is an endogenous bioactive peptide or protein secreted by adipocytes. Adiponectin is an insulin-sensitizing hormone that improves insulin resistance and arteriosclerosis, predicts the development of type II diabetes and coronary heart disease, and has demonstrated anti-diabetic, anti-atherotic and anti-inflammatory potential in clinical trials；the unit of adiponectin is: mg/dl. Blood collection and Adiponectin protein assay will be performed by an external company.
Hand Strength (HS)	From enrollment to the end of treatment at 3 months	Description: HS was measured to estimate muscle strength and was performed with a hand dynamometer (SAEHAN Digital Hand Dynamometer, SAEHAN, Changwon, Korea). During the HS test, participants had to hold the dynamometer in their hand with the arm stretched parallel to the body while being instructed to stand upright. This measure was performed three times on the dominant hand with a rest interval of 1 min between measurements; finally, the best performance was used as the maximum peak (PK) of HS (in kg). The statistical analysis also included mean peak (mean PK). The higher the grip strength value, the greater the muscle strength, the better the physical ability.
Skeletal Muscle Mass	From enrollment to the end of treatment at 3 months	Description: Using the Octupole Bioimpedance InBody 720 analyzer (Biospace, Seoul, Korea), participants wore light clothing and no shoes. The higher the number, the more muscle the human body has. The ideal skeletal muscle content for men is 47% of standard body weight and 42% of standard body weight for women. A 10% move up or down is considered normal.
Myostatin	From enrollment to the end of treatment at 3 months	Myostatin is a protein whose units are the same as those of other proteins, usually expressed in moles (mol/L). The MAGPIX platform enables multiplex tests, which allow for multi-parameter detection of several to several dozen analytes in a single sample of small volume (\~40ul). The MAGPIX (xMAP®) system is based on the principles of the ELISA test and uses the technology of paramagnetic microspheres coated with antibodies. One panel- Page 5 of 9 \[DRAFT\] allows for simultaneous determination of several to several dozen markers in each sample. ELISA (enzyme-linked immunosorbent assay) is an immunoenzymatic test used to detect and quantify proteins contained in the tested sample, such as antibodies or protein antigens. The ELISA technique is widely used in biomedical research, both scientific and diagnostic. It is a fast, accurate and easy to perform method. Consumables: nitrile gloves, pipette tips 10-200ul, pipette tips 100-1000ul, eppendorff tubes, other (falcon tubes, etc.)
Irisin	From enrollment to the end of treatment at 3 months	The unit of irisin is molecular weight and its value is 298.25. The MAGPIX platform enables multiplex tests, which allow for multi-parameter detection of several to several dozen analytes in a single sample of small volume (\~40ul). The MAGPIX (xMAP®) system is based on the principles of the ELISA test and uses the technology of paramagnetic microspheres coated with antibodies. One panel allows for simultaneous determination of several to several dozen markers in each sample. ELISA (enzyme-linked immunosorbent assay) is an immunoenzymatic test used to detect and quantify proteins contained in the tested sample, such as antibodies or protein antigens. The ELISA technique is widely used in biomedical research, both scientific and diagnostic. It is a fast, accurate and easy to perform method. Consumables: nitrile gloves, pipette tips 10-200ul, pipette tips 100-1000ul, eppendorff tubes, other (falcon tubes, lignin, etc.).
BDNF	From enrollment to the end of treatment at 3 months	BDNF (brain-derived neurotrophic factor) assay unit is mainly pg/mL. The MAGPIX platform enables multiplex tests, which allow for multi-parameter detection of several to several dozen analytes in a single sample of small volume (\~40ul). The MAGPIX (xMAP®) system is based on the principles of the ELISA test and uses the technology of paramagnetic microspheres coated with antibodies. One panel allows for simultaneous determination of several to several dozen markers in each sample. ELISA (enzyme-linked immunosorbent assay) is an immunoenzymatic test used to detect and quantify proteins contained in the tested sample, such as antibodies or protein antigens. The ELISA technique is widely used in biomedical research, both scientific and diagnostic. It is a fast, accurate and easy to perform method. Consumables: nitrile gloves, pipette tips 10-200ul, pipette tips 100-1000ul, eppendorff tubes, other (falcon tubes, lignin, etc.).
Arm strength index II	From enrollment to the end of treatment at 2 weeks	The arm flexor strength HS was measured by a dynamometer, and the BMI was measured in KG/m2. Arm strength index calculation formula: HS/BMI. A higher value for this indicator may mean greater muscle strength.
Knee extensor strength index	From enrollment to the end of treatment at 2 weeks	The knee extensor strength HS was measured using a dynamometer, and the weight BM was measured in kg using a weight scale. Knee extensor strength index calculation formula: HS/BM. A higher value for this indicator may mean greater muscle strength.
Knee flexor strength index	From enrollment to the end of treatment at 2 weeks	The knee flexor strength HS was measured using a dynamometer, and the weight BM was measured in kg using a weight scale. Knee flexor strength index calculation formula: HS/BM. A higher value for this indicator may mean greater muscle strength.
Pain tolerance (PTOL)	From enrollment to the end of treatment at 3 months	Pain tolerance (PTOL) was assessed using the Medoc AlgoMed Seaweed Meter (Israel). PTOL is the maximum pain intensity a person can withstand. Measurements are taken in a seated position on the back of the hand (between the thumb and forefinger) and the lateral arm (2/3 of the length of the arm). Stimulation was applied at a rate of 30 kPa/sec. Measurement ends when the participant can no longer tolerate stimulation.
Pain intensity score	From enrollment to the end of treatment at 3 months	Participants rated pain intensity using the VAS scale (0-10). The higher the score, the greater the level of pain.
Limits of Stability Test (LOS)	From enrollment to the end of treatment at 3 months	Subjects were subjected to a limits of stability Test (LOS) using the Biodex Equilibrium System (BBS). In the LOS test, the platform is stable and participants transfer their body weight to move the cursor from the central target to the peripheral target. This test measures the maximum angle that the body can reach vertically without losing its balance. Three trials were conducted.
International Physical Activity Questionnaire (IPAQ)	From enrollment to the end of treatment at 3 months	IPAQ evaluates activity over the past 7 days, focusing on vigorous and moderate activity and sitting time. Based on responses, total activity time is calculated and classified (low, moderate, high).
Arm Curl	From enrollment to the end of treatment at 3 months	Physical Fitness Test (SFT) levels in older adults were assessed by arm curl test. Measures upper body strength. The participant performs as many curls as possible in 30 seconds with a weight. Fewer than 11 curls indicate a risk zone.
6-Minute Walk	From enrollment to the end of treatment at 3 months	Physical Fitness Test (SFT) levels in older adults were assessed by 6-minute walk. Measures aerobic endurance. The participant walks as far as possible in 6 minutes. Walking less than 350 yards indicates a risk zone.
Chair Sit-and-Reach	From enrollment to the end of treatment at 3 months	Physical Fitness Test (SFT) levels in older adults were assessed by chair sit-and-reach. Measures lower body flexibility. A negative distance of more than 4 inches for men or 2 inches for women indicates a risk zone.
Back Scratch	From enrollment to the end of treatment at 3 months	Physical Fitness Test (SFT) levels in older adults were assessed by back scratch. Measures upper body flexibility. A gap of more than 4 inches for men or 2 inches for women indicates a risk zone.
8-Foot Up-and-Go	From enrollment to the end of treatment at 3 months	Physical Fitness Test (SFT) levels in older adults were assessed by 8-Foot Up-and-Go. Measures agility. A time over 9 seconds indicates a risk zone.
Leptin	From enrollment to the end of treatment at 3 months	Leptin is a hormone secreted by adipose tissue, and its amount in serum is proportional to the size of the animal's adipose tissue. The negative feedback mechanism of leptin in serum can regulate the energy balance of organisms as well as body weight. Leptin is measured in pg/ml. The level of leptin will be determined using the MAGPIX fluorescence detection system (Luminex Corp., Austin, TX, USA) and the Luminex human magnetic assay 6-Plex according to the manufacturer's protocol. Data acquisition and analysis will be performed using xPONENT software and Quantist Luminex from Bio-Techne (Luminex Corp., Austin, TX, USA). Blood tests will be carried out by an external company.
Resistin	From enrollment to the end of treatment at 3 months	Resistin is a cysteine-rich fat-derived peptide hormone that functions as a pro-inflammatory cytokine and can act as an important node in inflammatory diseases. Leptin is measured in pg/ml. The level of leptin will be determined using the MAGPIX fluorescence detection system (Luminex Corp., Austin, TX, USA) and the Luminex human magnetic assay 6-Plex according to the manufacturer's protocol. Data acquisition and analysis will be performed using xPONENT software and Quantist Luminex from Bio-Techne (Luminex Corp., Austin, TX, USA).

Trial Locations

Locations (1)

Gdansk University of Physical Education and Sport; 🇵🇱 Gdansk, Województwo Pomorskie, Poland