Physical Activity and Disability Prevention in Postmenopausal Women

NCT06781541 | Active Not Recruiting

• 2 other identifiers: AWFiS/2024_5_ZOwithout grant number
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Physical activity; aerobic capacity; mobility; cognitive functions; quality of life; disability; postmenopausal women; Physical fitness

Outcome Measures

Primary Outcomes (17)

• 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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Physical activity levels were monitored for 7 days prior to the test

Secondary Outcomes (36)

• PEAK AWY

  From enrollment to the end of treatment at 2 weeks

• PEAK TWD

  From enrollment to the end of treatment at 2 weeks

• Tandem Balance

  From enrollment to the end of treatment at 2 weeks

• Arm strength index

  From enrollment to the end of treatment at 2 weeks

• Skeletal Lean Mass

  From enrollment to the end of treatment at 2 weeks

Other Outcomes (40)

• Body Fat Mass

  From enrollment to the end of treatment at 2 weeks

• Fat-Free Mass

  From enrollment to the end of treatment at 2 weeks

• BMI

  From enrollment to the end of treatment at 2 weeks

Study Arms (5)

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.

Behavioral: Nordic walking

Daily life

EXPERIMENTAL

The individuals engaged in routine daily tasks, while being advised against incorporating any supplementary physical exertion.

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.

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.

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.

Behavioral: Functional general conditioning training

Interventions

Nordic walking BEHAVIORAL

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.

Nordic Walking

Strength training BEHAVIORAL

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.

Strength training

Bungy Pump Exercises BEHAVIORAL

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.

Bungy Pump Exercises

Daily life BEHAVIORAL

The individuals engaged in routine daily tasks, while being advised against incorporating any supplementary physical exertion.

Daily life

Functional general conditioning training BEHAVIORAL

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.

Functional general conditioning training

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gdansk University of Physical Education and Sport: lead
• Chengdu University of Traditional Chinese Medicine: collaborator

Study Sites (1)

Gdansk University of Physical Education and Sport

Gdansk, Pomeranian Voivodeship, 80-336, Poland

Location

Related Publications (11)

• 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.

  PMID: 31894552 BACKGROUND

• Gallardo-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.

  PMID: 35182742 BACKGROUND

• Todhunter-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.

  PMID: 36053030 BACKGROUND

• Hopewell 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.

  PMID: 30035305 BACKGROUND

• Huynh 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.

  PMID: 39431435 BACKGROUND

• Neilson 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.

  PMID: 24563822 BACKGROUND

• Remie 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.

  PMID: 34510226 BACKGROUND

• Ra 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.

  PMID: 34356226 BACKGROUND

• Teraz 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.

  PMID: 36909226 BACKGROUND

• Partridge 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.

  PMID: 30185958 BACKGROUND

• Ossowski 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.

  PMID: 27942207 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Bone Diseases, Metabolic; Cardiovascular Diseases; Dementia; Motor Activity

Interventions

Nordic Walking; Resistance Training

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Bone Diseases; Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Officials

• Zbigniew Ossowski, PHD

  AKADEMIA WYCHOWANIA FIZYCZNEGO I SPORTU

  STUDY CHAIR

• Yangjun Liu, PHD

  Chengdu University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: January 17, 2025
• Study Start: February 21, 2022
• Primary Completion: October 5, 2025
• Study Completion: October 15, 2025
• Last Updated: January 17, 2025

Record last verified: 2024-12

Locations

PL (1)