Metabolic SyndromePADP-WomenNCT06781541
Physical Activity and Disability Prevention in Postmenopausal Women
A study testing Nordic walking, Strength training and Bungy Pump Exercises in people with Metabolic Syndrome and Fall Risk, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Fall Risk, Sarcopenia in Elderly
- What is being tested?
- Nordic walking, Strength training and Bungy Pump Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePoland
- Study dates
- 21 Feb 2022to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Gdansk University of Physical Education and Sport
Gdansk, Pomeranian Voivodeship, 80-336
About this study
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:
- 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?
- Do regular exercises improve cognitive functions, motivation, memory, visual coordination, mood, and quality of life in postmenopausal women?
Read more
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.
Read the 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.
- Conditions
- Metabolic Syndrome, Fall Risk, Sarcopenia in Elderly, Osteopenia, Osteoporosis, Cardiovascular Diseases, Dementia
- Being tested
- Nordic walking, Strength training, Bungy Pump Exercises, Daily life, Functional general conditioning training
- Keywords
- Physical activity, aerobic capacity, mobility, cognitive functions, quality of life, disability, postmenopausal women, Physical fitness
- Medical subject headings
- Metabolic Syndrome, Bone Diseases, Metabolic, Cardiovascular Diseases, Dementia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nordic walkingBehavioural
NW training sessions are conducted by a certified NW instructor leading participants in the outdoor forest of Gdansk. Training is about 60 minutes each time, 3 times a week, each interval of 1 or 2 days, a total of 12 weeks. Participants used professional Nordic Pole.
Strength trainingBehavioural
Strength training was conducted in the gym with progressively increasing resistance from 65% to 75% of the maximum weight (one-repetition maximum (1-RM)). Participants performed 10-13 repetitions of the exercise in one serie. The training was carried out in station form and consisted of 10-13 exercises. There were rest intervals of 60-90 seconds between exercises. As intended, the training was comprehensive, i.e. it affected the muscles of the arms, legs, torso, abdomen and chest.
Bungy Pump ExercisesBehavioural
Buny Pump training sessions are conducted by a certified BP instructor leading participants in the outdoor forest of Gdansk. Training is about 60 minutes each time, 3 times a week, a total of 12 weeks. Participants used professional Bungy Pump Pole.
Daily lifeBehavioural
The individuals engaged in routine daily tasks, while being advised against incorporating any supplementary physical exertion.
Functional general conditioning trainingBehavioural
Training sessions were supervised by a certified instructor. Training was carried out at home with individually adjusted resistance depending on age and health. Participants typically performed 10-13 repetitions of a given exercise. 30-second rest intervals were used between exercises. As intended, the training was comprehensive, i.e. including muscles of the arms, legs, trunk, abdomen, chest, balance and flexibility exercises. Basic training equipment was used during the training.
| Study group | Role | What they receive |
|---|---|---|
| Nordic Walking | Experimental | Training is about 60 minutes each time, 3 times a week, each interval of 1 or 2 days, a total of 12 weeks. The primary focus is on utilizing a specialized pole for engaging in cross-country walking. This regimen entails approximately 10 minutes of warmup exercises, followed by around 40 minutes of brisk walking, and concluding with a period of relaxation stretching lasting between 5 to 8 minutes. Receives: Behavioral: Nordic walking |
| Daily life | Experimental | The individuals engaged in routine daily tasks, while being advised against incorporating any supplementary physical exertion. Receives: Behavioral: Daily life |
| Strength training | Experimental | Strength training was conducted in the gym with progressively increasing resistance from 65% to 75% of the maximum weight (one-repetition maximum (1-RM)). Participants performed 10-13 repetitions of the exercise in one serie. The training was carried out in station form and consisted of 10-13 exercises. There were rest intervals of 60-90 seconds between exercises. As intended, the training was comprehensive, i.e. it affected the muscles of the arms, legs, torso, abdomen and chest. Receives: Behavioral: Strength training |
| Bungy Pump Exercises | Experimental | The training lasts approximately 60 minutes each time, 3 times a week, for a period of 12 weeks. The main emphasis is placed on the use of a specialist Bungy Pump pole. Bungy Pump training allows participants to combine aerobic and strength training. Bungy Pump poles contain a built-in shock absorber (RSA) in the form of an elastic band. The additional resistance generated by the stretched band increases the overall intensity of the exercise and increases calorie consumption. The program classes will include approximately 10 minutes of warm-up exercises, followed by approximately 40 minutes of brisk walking, and at the end a period of relaxation stretching lasting from 5 to 8 minutes. Receives: Behavioral: Bungy Pump Exercises |
| Functional general conditioning training | Experimental | Functional general conditioning training was carried out at home with individually adjusted resistance depending on age and health. Participants typically performed 10-13 repetitions of a given exercise. 30-second rest intervals were used between exercises. As intended, the training was comprehensive, i.e. including muscles of the arms, legs, trunk, abdomen, chest, balance and flexibility exercises. Basic training equipment was used during the training. Receives: Behavioral: Functional general conditioning training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of Falls
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
Measured: From enrollment to the end of treatment at 3 months
Bone Density
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.
Measured: From enrollment to the end of treatment at 3 months
Triglycerides (Metabolic syndrome Indicators)
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.
Measured: From enrollment to the end of treatment at 3 months
Total cholesterol (Metabolic syndrome Indicators)
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.
Measured: From enrollment to the end of treatment at 3 months
High Density Lipoprotein Cholesterol (HDL-C)
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.
Measured: From enrollment to the end of treatment at 3 months
non-High Density Lipoprotein Cholesterol (no-HDL-C)
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.
Measured: From enrollment to the end of treatment at 3 months
Low Density Lipoprotein Cholesterol (LDL-C)
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.
Measured: From enrollment to the end of treatment at 3 months
Fasting blood glucose (FBG)
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.
Measured: From enrollment to the end of treatment at 3 months
Gait Speed
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.
Measured: From enrollment to the end of treatment at 2 weeks
Skeletal muscle index
SMI in InBody is calculated as follows: SMI= sum of segmental muscle mass (two arms and two legs) ÷ height 2
Measured: From enrollment to the end of treatment at 2 weeks
Cognitive Abilities Assessment
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.
Measured: From enrollment to the end of treatment at 3 months
Quality of Life
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.
Measured: From enrollment to the end of treatment at 3 months
VO2max
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.
Measured: From enrollment to the end of treatment at 3 months
Gait
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.
Measured: From enrollment to the end of treatment at 3 months
Static Balance
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.
Measured: From enrollment to the end of treatment at 3 months
Pelvic Floor Muscle Function
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.
Measured: From enrollment to the end of treatment at 3 months
Daily steps
Assess physical activity levels over 7 days using the POLAR accelerometer, record daily steps.
Measured: Physical activity levels were monitored for 7 days prior to the test
Secondary outcomes (36)
PEAK AWY
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.
Measured: From enrollment to the end of treatment at 2 weeks
PEAK TWD
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.
Measured: From enrollment to the end of treatment at 2 weeks
Tandem Balance
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.
Measured: From enrollment to the end of treatment at 2 weeks
Arm strength index
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.
Measured: From enrollment to the end of treatment at 2 weeks
Skeletal Lean Mass
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.
Measured: From enrollment to the end of treatment at 2 weeks
Pain pressure threshold (PPT)
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.
Measured: From enrollment to the end of treatment at 3 months
Electromyography
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.
Measured: From enrollment to the end of treatment at 3 months
Postural Stability Test (PST)
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.
Measured: From enrollment to the end of treatment at 3 months
Spatial memory assessment
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.
Measured: From enrollment to the end of treatment at 3 months
Global Physical Activity Questionnaire (GPAQ)
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).
Measured: From enrollment to the end of treatment at 3 months
Fall-related concerns
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.
Measured: From enrollment to the end of treatment at 3 months
Cognitive Ability
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.
Measured: From enrollment to the end of treatment at 3 months
30-Second Chair Stand
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.
Measured: From enrollment to the end of treatment at 3 months
Circumferences
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.
Measured: From enrollment to the end of treatment at 3 months
Forward Lean Test
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.
Measured: From enrollment to the end of treatment at 3 months
Sedentary time
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
Measured: From enrollment to the end of treatment at 3 months
Adiponectin (ADPN)
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.
Measured: From enrollment to the end of treatment at 3 months
Hand Strength (HS)
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.
Measured: From enrollment to the end of treatment at 3 months
Skeletal Muscle Mass
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.
Measured: From enrollment to the end of treatment at 3 months
Myostatin
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.)
Measured: From enrollment to the end of treatment at 3 months
Irisin
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.).
Measured: From enrollment to the end of treatment at 3 months
BDNF
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.).
Measured: From enrollment to the end of treatment at 3 months
Arm strength index II
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.
Measured: From enrollment to the end of treatment at 2 weeks
Knee extensor strength index
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.
Measured: From enrollment to the end of treatment at 2 weeks
Knee flexor strength index
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.
Measured: From enrollment to the end of treatment at 2 weeks
Pain tolerance (PTOL)
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.
Measured: From enrollment to the end of treatment at 3 months
Pain intensity score
Participants rated pain intensity using the VAS scale (0-10). The higher the score, the greater the level of pain.
Measured: From enrollment to the end of treatment at 3 months
Limits of Stability Test (LOS)
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.
Measured: From enrollment to the end of treatment at 3 months
International Physical Activity Questionnaire (IPAQ)
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).
Measured: From enrollment to the end of treatment at 3 months
Arm Curl
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.
Measured: From enrollment to the end of treatment at 3 months
6-Minute Walk
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.
Measured: From enrollment to the end of treatment at 3 months
Chair Sit-and-Reach
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.
Measured: From enrollment to the end of treatment at 3 months
Back Scratch
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.
Measured: From enrollment to the end of treatment at 3 months
8-Foot Up-and-Go
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.
Measured: From enrollment to the end of treatment at 3 months
Leptin
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.
Measured: From enrollment to the end of treatment at 3 months
Resistin
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).
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start21 Feb 2022
- Primary completion5 Oct 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gdansk University of Physical Education and Sport
- Sponsor type
- University, hospital or other
- Collaborators
- Chengdu University of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Zbigniew Ossowski, PHD, Study chair, AKADEMIA WYCHOWANIA FIZYCZNEGO I SPORTUYangjun Liu, PHD, Principal investigator, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781541
- Sponsor's protocol ID
- AWFiS/2024_5_ZO
- Other IDs
- without grant number
- Acronym
- PADP-Women
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There are some privacy concerns.
Publications
Ricci NA, Cunha AIL. Physical Exercise for Frailty and Cardiovascular Diseases. Adv Exp Med Biol. 2020;1216:115-129. doi: 10.1007/978-3-030-33330-0_12.
PubMed 31894552Gallardo-Gomez D, Del Pozo-Cruz J, Noetel M, Alvarez-Barbosa F, Alfonso-Rosa RM, Del Pozo Cruz B. Optimal dose and type of exercise to improve cognitive function in older adults: A systematic review and bayesian model-based network meta-analysis of RCTs. Ageing Res Rev. 2022 Apr;76:101591. doi: 10.1016/j.arr.2022.101591. Epub 2022 Feb 17.
PubMed 35182742Todhunter-Brown A, Hazelton C, Campbell P, Elders A, Hagen S, McClurg D. Conservative interventions for treating urinary incontinence in women: an Overview of Cochrane systematic reviews. Cochrane Database Syst Rev. 2022 Sep 2;9(9):CD012337. doi: 10.1002/14651858.CD012337.pub2.
PubMed 36053030Hopewell S, Adedire O, Copsey BJ, Boniface GJ, Sherrington C, Clemson L, Close JC, Lamb SE. Multifactorial and multiple component interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2018 Jul 23;7(7):CD012221. doi: 10.1002/14651858.CD012221.pub2.
PubMed 30035305Huynh E, Wiley E, Noguchi KS, Fang H, Beauchamp MK, MacDonald MJ, Tang A. The effects of aerobic exercise on cardiometabolic health in postmenopausal females: A systematic review and meta-analysis of randomized controlled trials. Womens Health (Lond). 2024 Jan-Dec;20:17455057241290889. doi: 10.1177/17455057241290889.
PubMed 39431435Neilson HK, Conroy SM, Friedenreich CM. The Influence of Energetic Factors on Biomarkers of Postmenopausal Breast Cancer Risk. Curr Nutr Rep. 2013 Dec 15;3(1):22-34. doi: 10.1007/s13668-013-0069-8. eCollection 2014.
PubMed 24563822Remie CME, Janssens GE, Bilet L, van Weeghel M, Duvivier BMFM, de Wit VHW, Connell NJ, Jorgensen JA, Schomakers BV, Schrauwen-Hinderling VB, Hoeks J, Hesselink MKC, Phielix E, Houtkooper RH, Schrauwen P. Sitting less elicits metabolic responses similar to exercise and enhances insulin sensitivity in postmenopausal women. Diabetologia. 2021 Dec;64(12):2817-2828. doi: 10.1007/s00125-021-05558-5. Epub 2021 Sep 12.
PubMed 34510226Ra JS, Kim H. Combined Effects of Unhealthy Lifestyle Behaviors on Metabolic Syndrome among Postmenopausal Women. Healthcare (Basel). 2021 Jul 5;9(7):848. doi: 10.3390/healthcare9070848.
PubMed 34356226Teraz K, Kalc M, Peskar M, Pisot S, Simunic B, Pisot R, Pori P. Sarcopenia, obesity, and their association with selected behavioral factors in active older adults. Front Physiol. 2023 Feb 23;14:1129034. doi: 10.3389/fphys.2023.1129034. eCollection 2023.
PubMed 36909226Partridge L, Deelen J, Slagboom PE. Facing up to the global challenges of ageing. Nature. 2018 Sep;561(7721):45-56. doi: 10.1038/s41586-018-0457-8. Epub 2018 Sep 5.
PubMed 30185958Ossowski ZM, Skrobot W, Aschenbrenner P, Cesnaitiene VJ, Smaruj M. Effects of short-term Nordic walking training on sarcopenia-related parameters in women with low bone mass: a preliminary study. Clin Interv Aging. 2016 Nov 30;11:1763-1771. doi: 10.2147/CIA.S118995. eCollection 2016.
PubMed 27942207Tan L, Huminska-Lisowska K, Radziminski L, Zhang Q, Michalowska-Sawczyn M, Dzitkowska-Zabielska M, Ossowski Z. Concurrent improvement of cardiorespiratory fitness and modulation of inflammatory markers via 12-week high-intensity interval nordic walking in postmenopausal women with overweight or obesity: a quasi-experimental study. BMC Sports Sci Med Rehabil. 2026 Jun 9;18(1):332. doi: 10.1186/s13102-026-01798-3.
PubMed 42265787Niu Y, Wiech M, Qian G, Mao S, Ossowski Z. Adaptations in red blood cell indices and physical performance following bungy pump training in postmenopausal women. Front Physiol. 2026 Apr 17;17:1824312. doi: 10.3389/fphys.2026.1824312. eCollection 2026.
PubMed 42078205Niu Y, Radziminski L, Qian G, Szwarc A, Ossowski Z. Effect of a 12-week bungy pump training on cardiorespiratory fitness, metabolic syndrome factors and body composition in postmenopausal women. Sci Rep. 2025 Nov 25;15(1):41938. doi: 10.1038/s41598-025-25909-1.
PubMed 41290844
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Disability Prevention in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06781541
- Acronym / sponsor ID
- PADP-Women / AWFiS/2024_5_ZO
- Conditions
- Metabolic Syndrome, Fall Risk, Sarcopenia in Elderly, Osteopenia, Osteoporosis, Cardiovascular Diseases, Dementia
- Keywords
- Physical activity, aerobic capacity, mobility, cognitive functions, quality of life, disability, postmenopausal women, Physical fitness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Gdansk University of Physical Education and SportUniversity, hospital or other
- Collaborators
- Chengdu University of Traditional Chinese Medicine
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 5 Oct 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Nordic Walking | Experimental | Behavioral: Nordic walkingTraining is about 60 minutes each time, 3 times a week, each interval of 1 or 2 days, a total of 12 weeks. The primary focus is on utilizing a specialized pole for engaging in cross-country walking. This regimen entails approximately 10 minutes of warmup exercises, followed by around 40 minutes of brisk walking, and concluding with a period of relaxation stretching lasting between 5 to 8 minutes. |
| Daily life | Experimental | Behavioral: Daily lifeThe individuals engaged in routine daily tasks, while being advised against incorporating any supplementary physical exertion. |
| Strength training | Experimental | Behavioral: Strength trainingStrength training was conducted in the gym with progressively increasing resistance from 65% to 75% of the maximum weight (one-repetition maximum (1-RM)). Participants performed 10-13 repetitions of the exercise in one serie. The training was carried out in station form and consisted of 10-13 exercises. There were rest intervals of 60-90 seconds between exercises. As intended, the training was comprehensive, i.e. it affected the muscles of the arms, legs, torso, abdomen and chest. |
| Bungy Pump Exercises | Experimental | Behavioral: Bungy Pump ExercisesThe training lasts approximately 60 minutes each time, 3 times a week, for a period of 12 weeks. The main emphasis is placed on the use of a specialist Bungy Pump pole. Bungy Pump training allows participants to combine aerobic and strength training. Bungy Pump poles contain a built-in shock absorber (RSA) in the form of an elastic band. The additional resistance generated by the stretched band increases the overall intensity of the exercise and increases calorie consumption. The program classes will include approximately 10 minutes of warm-up exercises, followed by approximately 40 minutes of brisk walking, and at the end a period of relaxation stretching lasting from 5 to 8 minutes. |
| Functional general conditioning training | Experimental | Behavioral: Functional general conditioning trainingFunctional general conditioning training was carried out at home with individually adjusted resistance depending on age and health. Participants typically performed 10-13 repetitions of a given exercise. 30-second rest intervals were used between exercises. As intended, the training was comprehensive, i.e. including muscles of the arms, legs, trunk, abdomen, chest, balance and flexibility exercises. Basic training equipment was used during the training. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nordic walkingNW training sessions are conducted by a certified NW instructor leading participants in the outdoor forest of Gdansk. Training is about 60 minutes each time, 3 times a week, each interval of 1 or 2 days, a total of 12 weeks. Participants used professional Nordic Pole. | Behavioural | Nordic Walking |
| Strength trainingStrength training was conducted in the gym with progressively increasing resistance from 65% to 75% of the maximum weight (one-repetition maximum (1-RM)). Participants performed 10-13 repetitions of the exercise in one serie. The training was carried out in station form and consisted of 10-13 exercises. There were rest intervals of 60-90 seconds between exercises. As intended, the training was comprehensive, i.e. it affected the muscles of the arms, legs, torso, abdomen and chest. | Behavioural | Strength training |
| Bungy Pump ExercisesBuny Pump training sessions are conducted by a certified BP instructor leading participants in the outdoor forest of Gdansk. Training is about 60 minutes each time, 3 times a week, a total of 12 weeks. Participants used professional Bungy Pump Pole. | Behavioural | Bungy Pump Exercises |
| Daily lifeThe individuals engaged in routine daily tasks, while being advised against incorporating any supplementary physical exertion. | Behavioural | Daily life |
| Functional general conditioning trainingTraining sessions were supervised by a certified instructor. Training was carried out at home with individually adjusted resistance depending on age and health. Participants typically performed 10-13 repetitions of a given exercise. 30-second rest intervals were used between exercises. As intended, the training was comprehensive, i.e. including muscles of the arms, legs, trunk, abdomen, chest, balance and flexibility exercises. Basic training equipment was used during the training. | Behavioural | Functional general conditioning training |
Primary outcome
Risk of Falls
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Low Density Lipoprotein Cholesterol (LDL-C)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
36 secondary outcomes
PEAK AWY
Time frame: From enrollment to the end of treatment at 2 weeks
PEAK TWD
Time frame: From enrollment to the end of treatment at 2 weeks
Tandem Balance
Time frame: From enrollment to the end of treatment at 2 weeks
Arm strength index
Time frame: From enrollment to the end of treatment at 2 weeks
Skeletal Lean Mass
Time frame: From enrollment to the end of treatment at 2 weeks
Pain pressure threshold (PPT)
Time frame: From enrollment to the end of treatment at 3 months
Electromyography
Time frame: From enrollment to the end of treatment at 3 months
Postural Stability Test (PST)
Time frame: From enrollment to the end of treatment at 3 months
Spatial memory assessment
Time frame: From enrollment to the end of treatment at 3 months
Global Physical Activity Questionnaire (GPAQ)
Time frame: From enrollment to the end of treatment at 3 months
Fall-related concerns
Time frame: From enrollment to the end of treatment at 3 months
Cognitive Ability
Time frame: From enrollment to the end of treatment at 3 months
30-Second Chair Stand
Time frame: From enrollment to the end of treatment at 3 months
Circumferences
Time frame: From enrollment to the end of treatment at 3 months
Forward Lean Test
Time frame: From enrollment to the end of treatment at 3 months
Sedentary time
Time frame: From enrollment to the end of treatment at 3 months
Adiponectin (ADPN)
Time frame: From enrollment to the end of treatment at 3 months
Hand Strength (HS)
Time frame: From enrollment to the end of treatment at 3 months
Skeletal Muscle Mass
Time frame: From enrollment to the end of treatment at 3 months
Myostatin
Time frame: From enrollment to the end of treatment at 3 months
Irisin
Time frame: From enrollment to the end of treatment at 3 months
BDNF
Time frame: From enrollment to the end of treatment at 3 months
Arm strength index II
Time frame: From enrollment to the end of treatment at 2 weeks
Knee extensor strength index
Time frame: From enrollment to the end of treatment at 2 weeks
Knee flexor strength index
Time frame: From enrollment to the end of treatment at 2 weeks
Pain tolerance (PTOL)
Time frame: From enrollment to the end of treatment at 3 months
Pain intensity score
Time frame: From enrollment to the end of treatment at 3 months
Limits of Stability Test (LOS)
Time frame: From enrollment to the end of treatment at 3 months
International Physical Activity Questionnaire (IPAQ)
Time frame: From enrollment to the end of treatment at 3 months
Arm Curl
Time frame: From enrollment to the end of treatment at 3 months
6-Minute Walk
Time frame: From enrollment to the end of treatment at 3 months
Chair Sit-and-Reach
Time frame: From enrollment to the end of treatment at 3 months
Back Scratch
Time frame: From enrollment to the end of treatment at 3 months
8-Foot Up-and-Go
Time frame: From enrollment to the end of treatment at 3 months
Leptin
Time frame: From enrollment to the end of treatment at 3 months
Resistin
Time frame: From enrollment to the end of treatment at 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Background: PubMed 31894552Ricci NA, Cunha AIL. Physical Exercise for Frailty and Cardiovascular Diseases. Adv Exp Med Biol. 2020;1216:115-129. doi: 10.1007/978-3-030-33330-0_12.
- Background: PubMed 35182742Gallardo-Gomez D, Del Pozo-Cruz J, Noetel M, Alvarez-Barbosa F, Alfonso-Rosa RM, Del Pozo Cruz B. Optimal dose and type of exercise to improve cognitive function in older adults: A systematic review and bayesian model-based network meta-analysis of RCTs. Ageing Res Rev. 2022 Apr;76:101591. doi: 10.1016/j.arr.2022.101591. Epub 2022 Feb 17.
- Background: PubMed 36053030Todhunter-Brown A, Hazelton C, Campbell P, Elders A, Hagen S, McClurg D. Conservative interventions for treating urinary incontinence in women: an Overview of Cochrane systematic reviews. Cochrane Database Syst Rev. 2022 Sep 2;9(9):CD012337. doi: 10.1002/14651858.CD012337.pub2.
- Results publication: PubMed 30035305Hopewell S, Adedire O, Copsey BJ, Boniface GJ, Sherrington C, Clemson L, Close JC, Lamb SE. Multifactorial and multiple component interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2018 Jul 23;7(7):CD012221. doi: 10.1002/14651858.CD012221.pub2.
- Results publication: PubMed 39431435Huynh E, Wiley E, Noguchi KS, Fang H, Beauchamp MK, MacDonald MJ, Tang A. The effects of aerobic exercise on cardiometabolic health in postmenopausal females: A systematic review and meta-analysis of randomized controlled trials. Womens Health (Lond). 2024 Jan-Dec;20:17455057241290889. doi: 10.1177/17455057241290889.
- Results publication: PubMed 24563822Neilson HK, Conroy SM, Friedenreich CM. The Influence of Energetic Factors on Biomarkers of Postmenopausal Breast Cancer Risk. Curr Nutr Rep. 2013 Dec 15;3(1):22-34. doi: 10.1007/s13668-013-0069-8. eCollection 2014.
- Results publication: PubMed 34510226Remie CME, Janssens GE, Bilet L, van Weeghel M, Duvivier BMFM, de Wit VHW, Connell NJ, Jorgensen JA, Schomakers BV, Schrauwen-Hinderling VB, Hoeks J, Hesselink MKC, Phielix E, Houtkooper RH, Schrauwen P. Sitting less elicits metabolic responses similar to exercise and enhances insulin sensitivity in postmenopausal women. Diabetologia. 2021 Dec;64(12):2817-2828. doi: 10.1007/s00125-021-05558-5. Epub 2021 Sep 12.
- Results publication: PubMed 34356226Ra JS, Kim H. Combined Effects of Unhealthy Lifestyle Behaviors on Metabolic Syndrome among Postmenopausal Women. Healthcare (Basel). 2021 Jul 5;9(7):848. doi: 10.3390/healthcare9070848.
- Results publication: PubMed 36909226Teraz K, Kalc M, Peskar M, Pisot S, Simunic B, Pisot R, Pori P. Sarcopenia, obesity, and their association with selected behavioral factors in active older adults. Front Physiol. 2023 Feb 23;14:1129034. doi: 10.3389/fphys.2023.1129034. eCollection 2023.
- Results publication: PubMed 30185958Partridge L, Deelen J, Slagboom PE. Facing up to the global challenges of ageing. Nature. 2018 Sep;561(7721):45-56. doi: 10.1038/s41586-018-0457-8. Epub 2018 Sep 5.
- Results publication: PubMed 27942207Ossowski ZM, Skrobot W, Aschenbrenner P, Cesnaitiene VJ, Smaruj M. Effects of short-term Nordic walking training on sarcopenia-related parameters in women with low bone mass: a preliminary study. Clin Interv Aging. 2016 Nov 30;11:1763-1771. doi: 10.2147/CIA.S118995. eCollection 2016.
- Derived from this study: PubMed 42265787Tan L, Huminska-Lisowska K, Radziminski L, Zhang Q, Michalowska-Sawczyn M, Dzitkowska-Zabielska M, Ossowski Z. Concurrent improvement of cardiorespiratory fitness and modulation of inflammatory markers via 12-week high-intensity interval nordic walking in postmenopausal women with overweight or obesity: a quasi-experimental study. BMC Sports Sci Med Rehabil. 2026 Jun 9;18(1):332. doi: 10.1186/s13102-026-01798-3.
- Individual participant dataSharing planned: Undecided. There are some privacy concerns.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zbigniew Ossowski, PHD study chair
AKADEMIA WYCHOWANIA FIZYCZNEGO I SPORTU
Yangjun Liu, PHD principal investigator
Chengdu University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nordic walking, Strength training and Bungy Pump Exercises in people with Metabolic Syndrome and Fall Risk, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of Falls (time frame: From enrollment to the end of treatment at 3 months). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06781541, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.