- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07519720
An Assessment of Risk Factors for Osteosarcopenia in Older Adults - the Role of Prevention, Lifestyle, Physical Activity and Education.
Risk Factors for Osteosarcopenia, From a Multidisciplinary Perspective on the Prevention and Treatment of Older Adults, Based on Lifestyle Modifications Including Physical Activity, Healthy Eating Habits and Education.
The aim of the study is to assess the risk factors for osteosarcopenia in older adults, taking into account physical activity, healthy eating habits and education.
During the project, the following will be assessed: bone density, handgrip strength, physical activity, functional physical fitness, the incidence of falls and bone fractures over the last 10 years, and dietary habits. The results of the study will then be compared with those of a younger population.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Wroclaw, Poland
- Wroclaw University of Health and Sport Sciences, Poland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- people aged 60-80,
- people who are independent and have no mobility limitations requiring the use of assistive devices (wheelchair, walking frame),
- people who are mentally alert and show no signs of dementia,
- people with no current acute medical conditions,
- people who have given their informed consent to participate in the study.
Exclusion Criteria:
musculoskeletal injuries that have limited physical ability in the last 3 months,
- a recent bone densitometry scan using dual-energy X-ray absorptiometry (DXA), carried out within the last 12 months,
- chronic conditions in an acute phase (e.g. rheumatoid arthritis, advanced-stage diabetes),
- inability to cooperate, e.g. due to language or cognitive barriers.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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people aged 60-80
The study will involve people aged 60-80 with diverse lifestyles.
Groups of older adults will be recruited from Universities of the Third Age, Senior Citizens' Clubs, University Alumni Associations, the Wrocław Senior Citizens' Centre, and through advertisements in the media.
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The study will examine the relationship between the frequency of falls and fractures and the parameters obtained in the studies regarding body composition, muscle strength and functional fitness, as well as age, gender, lifestyle, current levels of physical activity and dietary habits.
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people aged <60
The study will involve people under the age of 60 with different lifestyles.
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The study will examine the relationship between the frequency of falls and fractures and the parameters obtained in the studies regarding body composition, muscle strength and functional fitness, as well as age, gender, lifestyle, current levels of physical activity and dietary habits.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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A bone density scan
Time Frame: Day 1
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A bone density scan (densitometry) allows for the precise measurement of mineral content (primarily calcium) in bone tissue, enabling the early detection of osteoporosis and osteopenia before a fracture occurs. This is crucial for assessing fracture risk, monitoring the effectiveness of treatment and prevention, particularly in people over the age of 50. A Lunar iDXA (dual-energy X-ray absorptiometry - DXA) will be used to perform densitometry tests, as a method for measuring bone mineral density (BMD) in the lumbar spine, the proximal femur and the wrist. |
Day 1
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The body composition test the BIA (Bioelectrical Impedance Analysis) - Body weight
Time Frame: Day 1
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A body composition analysis using the BIA (Bioelectrical Impedance Analysis) method allows for the determination of key body composition parameters, such as: body weight in kilograms.
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Day 1
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The body composition test the BIA (Bioelectrical Impedance Analysis) - Body fat mass
Time Frame: Day 1
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A body composition analysis using the BIA (Bioelectrical Impedance Analysis) method allows for the determination of key body composition parameters, such as: body fat mass. In body composition analysis using the bioelectrical impedance analysis (BIA) method, the Body Fat Mass parameter is expressed in two main forms: Kilograms (kg): This is the absolute mass of body fat. Percentages (%): This is the percentage of fat relative to total body weight, often denoted as BF% (Body Fat). Furthermore, in segmental analysis (segmental BIA), analysers may also provide fat mass for specific body parts (e.g. arms, legs, torso) in kilograms (kg). |
Day 1
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The body composition test BIA - visceral fat
Time Frame: Day 1
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Visceral fat, as measured by bioelectrical impedance analysis (BIA), is most commonly expressed as a numerical value (level) rather than in units of mass or as a percentage. Scale (Level): The result is usually given as a number between 1 and 20, 30 or 59, depending on the device manufacturer (e.g. Tanita). Normal range: A normal level of visceral fat is usually a result within the range of 1-12. |
Day 1
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The body composition test the BIA (Bioelectrical Impedance Analysis) - Lean Body Mass
Time Frame: Day 1
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Lean Body Mass (LBM) in body composition analysis using the BIA (bioelectrical impedance analysis) method is expressed in units of mass: Kilograms (kg) - the most common unit in devices available in Poland and Europe. Additionally, on printouts from BIA analysers, this value is often converted into a percentage of total body weight (%) to facilitate assessment of its composition in relation to fat. |
Day 1
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The body composition test the BIA (Bioelectrical Impedance Analysis) - Body Mass Index (BMI)
Time Frame: Day 1
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Weight and height will be combined to report BMI in kg/m^2
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Day 1
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The body composition test the BIA (Bioelectrical Impedance Analysis) - Metabolic age
Time Frame: Day 1
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Metabolic age in a BIA (bioelectrical impedance analysis) test is expressed in years. Range: Devices (e.g. Tanita) typically display a metabolic age ranging from 12 to 90 years. Interpretation: This result compares your basal metabolic rate (BMR) with the average chronological age for that value. |
Day 1
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The body composition test the BIA (Bioelectrical Impedance Analysis) - muscule mass
Time Frame: Day 1
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In body composition analysis using the electrical bioimpedance analysis (BIA) method, muscle mass (or skeletal muscle mass - SMM) is most commonly expressed in the following units: Kilograms (kg) - this is the basic unit used to determine the absolute muscle mass in the body. Percentages (%) - in many advanced analysers, muscle mass is also presented as a percentage of total body weight. |
Day 1
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The body composition test the BIA (Bioelectrical Impedance Analysis) - Bone mass
Time Frame: Day 1
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In body composition analysis using the bioelectrical impedance analysis (BIA) method, bone mass is given in kilograms (kg). Key information about bone mass measurement in BIA: This measurement estimates the mass of bone minerals in the body (however, it is not the same as a DEXA bone density scan). Reference ranges: In women, bone mass is usually around 2-3 kg, and in men 2.5-4 kg. The result generally reflects the overall health of the skeleton, and a fall below certain values may suggest a risk of osteopenia or osteoporosis. |
Day 1
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The body composition test the BIA (Bioelectrical Impedance Analysis) - the both intracellular (ICW) and extracellular water content (ECW)
Time Frame: Day 1
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In bioelectrical impedance analysis (BIA) tests, the content of intracellular water (ICW) and extracellular water (ECW) is most commonly expressed in the following units: Litres (L) - to determine the absolute volume of fluids. Percentage of body weight (%) - to determine the proportion of water in total body weight. |
Day 1
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Assessment of physical activity using the IPAQ questionnaire
Time Frame: Day 1
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The International Physical Activity Questionnaire (IPAQ) is a standardized tool used to assess7-day recall of physical activity (walking, moderate-intensity, and vigorous-intensity) and sitting time, available in short (surveillance) and long (detailed research) forms for adults aged 15-69.
It calculates activity in MET-min/week to categorize individuals into low, moderate, or high activity.
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Day 1
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The KomPAN Questionnaire (Dietary Habits and Nutrition Beliefs Questionnaire)
Time Frame: Day 1
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The KomPAN Questionnaire (Dietary Habits and Nutrition Beliefs Questionnaire) This tool was developed by the Behavioural Determinants of Nutrition Team of the Committee on Human Nutrition Sciences at the Polish Academy of Sciences (PAN). Purpose: To investigate the dietary beliefs and habits of adult Poles. Application: The questionnaire enables the assessment of:
The questionnaire includes a set of questions on the frequency of food consumption (FFQ - Food Frequency Questionnaire). |
Day 1
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The SCREEN II questionnaire (Seniors in the Community: Risk Evaluation for Eating and Nutrition)
Time Frame: Day 1
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The SCREEN II questionnaire (Seniors in the Community: Risk Evaluation for Eating and Nutrition) This is a Canadian tool that has been validated and is also used in Poland. Purpose: Screening for the risk of malnutrition in older people (aged 60-65 and over) living at home (independently). Use: It helps to identify older people at risk of nutritional problems before serious malnutrition occurs. It consists of questions concerning: changes in body weight, appetite, number of meals, difficulties with eating, and the amount of selected food groups consumed. In Poland, it is used, amongst other things, to assess the quality of the diet of senior club members. |
Day 1
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Short Physical Performance Battery - Test: Timed up and go (TUG)
Time Frame: Day 1
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A tool used to assess the physical fitness of older people in three areas: lower-body strength, static balance and walking speed, handgrip strength assessment. The Timed Up and Go (TUG) test is a quick clinical test that assesses functional mobility, dynamic balance and the risk of falls, particularly in older people. It involves measuring the time (in seconds) it takes for the participant to stand up from a chair, walk 3 metres, turn around, walk back and sit down again. |
Day 1
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Short Physical Performance Battery - The 5-Times Sit-to-Stand Test (5XSST)
Time Frame: Day 1
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A tool used to assess the physical fitness of older people in three areas: e.g. lower-body strength, static balance and walking speed, handgrip strength assessment. The 5-Times Sit-to-Stand Test (5XSST) is a simple, functional test of physical fitness that measures the time taken to stand up from a chair five times without using one's hands. The aim of the test is to assess lower limb muscle strength, primarily that of the quadriceps, measure functional mobility, assess the ability to perform everyday activities such as standing up from a chair or a car, and assess the risk of falls - a higher score (longer time) is associated with a greater risk of falling in older people. A result of less than 12-15 seconds is considered normal for most adults. Risk: A result of over 15 seconds suggests functional limitations and a higher risk of falling, particularly in older people. Age: Norms may vary depending on age (e.g. for people aged 80-89, a result of over 14.8 secon |
Day 1
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Short Physical Performance Battery - The test HGS (Hand Grip Strength)
Time Frame: Day 1
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A tool used to assess the physical fitness of older people in three areas: e.g. lower-body strength, static balance and walking speed, handgrip strength assessment. HGS (Hand Grip Strength) tests, which measure hand grip strength, involve the objective measurement of the maximum isometric strength of the finger and hand flexor muscles using a portable device known as a hand dynamometer. It is a simple, quick and non-invasive test that serves as an indicator of overall muscle strength and bodily function, as well as a marker of metabolic health and long life. The test measures and assesses grip strength in kilograms (kg) or pounds (lbs). A hand dynamometer (e.g. Jamar) is used for the test, which the subject squeezes. The subject squeezes the device's handle as hard as they can for approximately 3-5 seconds. The measurement is usually repeated 2-3 times for both hands (dominant and non-dominant) with rest intervals, and the highest value obtained is taken as the result. |
Day 1
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 19/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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