Clinical trial NCT06606769: Physical Activity Guarantees Bone Density.
Official title: Fizyczne Aktywnosci Gwarantem Zdrowych Kosci
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoporosis
Osteopenia
Keywords: physical activity
bone mineral density
Lead sponsor: Poznan University of Physical Education
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 300
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Bone tissue is crucial for overall health and quality of life, but it undergoes constant internal remodeling, leading to osteoporosis, a widespread bone disease. Regular physical activity can improve bone mineral density (BMD) and prevent osteoporosis. Studies have shown that premenopausal women with regular physical activity have greater BMD. Diagnosing bone resorption is essential, and dual-energy X-ray absorptiometry tests (DXA) and circulating microRNAs (miRNAs) may offer more prognostic potential than conventional markers. The gut microbiome may also regulate bone metabolism, with metabolites like trimethylamine N-oxide (TMAO) playing a role. A project aims to promote systematic physical activity to improve BMD and well-being, support societal mobilization, and conduct preventive examinations for osteoporosis risk. Implementing systematic prevention is important not only for health but also for reducing social and financial costs associated with osteoporosis and associated fractures.

Detailed description: Bone tissue, in addition to providing the body with supportive functions and protecting organs from injury, is a metabolically active tissue that influences the proper functioning of other organs. Therefore, bones are essential for overall health and quality of life. Bones undergo constant internal remodeling. With prolonged resorption dominance, bone mass decreases, accompanied by a deterioration of microarchitecture leading to impaired bone strength. This pathological condition is called osteoporosis and is one of the most widespread bone diseases in the world.

In recent years, there has been increasing discussion about the beneficial impact of physical activity on human health. Broadly understood physical activity affects the skeletal system, which translates into the stimulation of processes related to bone formation in the body. It is very important that exercises are performed regularly. Among premenopausal women who regularly engage in physical activity, a greater bone mineral density (BMD) has been observed compared to a group of women who do not participate in any physical activity. Therefore, there is a need to promote physical activity and to tailor physical activities according to the needs arising from both the principles of osteoporosis prevention and the age or hormonal status of women.

It is important to note that bone tissue loss is painless and progresses asymptomatically, gradually weakening the bones. Therefore, it is very important to conduct studies that diagnose the progress of bone resorption. A milestone in the diagnosis of osteoporosis is undoubtedly the dual-energy X-ray absorptiometry test. (DXA). Circulating microRNAs (miRNAs) may potentially serve as an attractive alternative or addition to the diagnostic arsenal and offer greater prognostic potential than conventional markers. Furthermore, an increasing number of studies show that the gut microbiome may be a key factor regulating bone physiology. It has been shown that bone metabolism can be regulated by metabolites dependent on the gut microbiome. The metabolite in question is trimethylamine N-oxide. (TMAO). However, so far, there have been few studies addressing the impact of TMAO on bone metabolism, as well as the underlying molecular mechanisms, and the results obtained are not conclusive.

The project aims to promote systematic physical activity that improves not only BMD but also the well-being of every individual who exercises. By increasing the availability of activation programs, this project supports the mobilization of society. Furthermore, the preventive examinations conducted among individuals qualified for the project allow for the early detection of an increased risk of developing osteoporosis. Early diagnosis of the disease prevents serious consequences in the future and increases the chances of a complete cure. At the same time, the project will undertake pioneering research aimed at enhancing the quality and excellence of the scientific and research staff.

The implementation of systematic prevention for this condition is particularly important not only in the context of health but also due to the significant social and financial costs of treating the consequences of osteoporosis and its associated fractures.

Eligibility criteria: Inclusion Criteria:

women

Exclusion Criteria:

diagnosed osteoporosis

Primary outcomes:
measure: bone mineral density
timeFrame: before and after 12 months of intervention
Secondary outcomes:
measure: blood markers
timeFrame: before and after 12 months of intervention
measure: physical fitness tests
timeFrame: before and after 12 months of intervention
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Physical Education
Study officials:
affiliation: Poznan University of Physical Education
name: Robert A Olek, professor
role: PRINCIPAL_INVESTIGATOR
References: