Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06606769

Physical Activity Guarantees Bone Density.

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Poznan University of Physical Education

Poznan, 61-871, Poland

Location status: Recruiting

Location contact

Maja Mackowiak

CONTACT

[email protected]

+48 61 8355270

Robert A Olek, professor

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

women

Exclusion criteria

diagnosed osteoporosis

Treatment and study plan

Exercise

Other

supervised exercise training; twice a week for 12 months

Primary outcomes

  1. bone mineral density

    Time frame: before and after 12 months of intervention

    BMD using dual-energy X-ray absorptiometry (DXA)

Secondary outcomes

  1. blood markers

    Time frame: before and after 12 months of intervention

    C-terminal telopeptide of type 1 collagen aminoterminal propeptide of type I procollagen trimethylamine N-oxide microRNA complete blood count

  2. physical fitness tests

    Time frame: before and after 12 months of intervention

    hand grip strength maximum vertical jump Chester step test

Study contacts

Contact information is provided by the study sponsor or research team.

Maja Mackowiak

CONTACT

[email protected]

+48618355270

Sponsors and collaborators

Lead sponsor

Poznan University of Physical Education

Other

Registry information

Official study title

Fizyczne Aktywnosci Gwarantem Zdrowych Kosci

Acronym: BONES

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 23, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.