Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05538377 |
| Other study ID # |
CFC22OST |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2022 |
| Est. completion date |
May 1, 2024 |
Study information
| Verified date |
September 2022 |
| Source |
Universitat Internacional de Catalunya |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The high annual incidence of osteporosis and its high prevalence , means that more and more
resources are being devoted to its diagnosis, prevention and treatment in primary care. This
pathology is defined as a skeletal disorder characterized by an alteration in bone strength,
mainly reflecting a poor integration of bone density and quality.
The reduction of the mass and the alteration of the microstructure of osteoporotic bone lead
to an increase in its fragility and an increase in the risk of suffering bone fractures. If
we add to this the alterations in balance observed in older people, the possibility of
fracture and increased fragility increases. It is estimated that every 3 seconds there is an
osteoporotic fracture and it is considered that every year 8.9 million fractures of this type
occur worldwide. Fragility fractures are estimated to be associated with significant
morbidity and mortality. In the case of hip fracture as a consequence of osteoporosis, only
30-45% of surviving cases recover pre-fracture functional status and 32-80% suffer some form
of significant dysfunction, thus representing a high economic and social cost.
Associated with osteoporosis, numerous studies have also observed a decrease in strength
and/or muscle mass (sarcopenia), thus increasing the fragility and deterioration of the
patient suffering from osteoporosis. Tokeshi et al. observed that patients with osteoporotic
fractures had less muscle mass compared to patients without osteoporosis. Hoo Lee and Sik
Gong describe that lower extremity muscle mass and loss of grip are closely related to the
occurrence of an osteoporotic vertebral fracture and numerous investigations show the
relationship between grip strength and osteoporotic fractures in the elderly.
For the diagnosis of osteoporosis, double beam X-ray densitometry (DEXA) is used and
osteoporosis is considered to be present when the osteoporosis values are below 2.5 standard
deviations (SD) of the peak bone mass, the maximum value reached in young women.
At the therapeutic level, pharmacology is the treatment recommended in clinical practice
guidelines. However, due to poor adherence and adverse effects, the recommendation of
physical activity programs is becoming more and more popular to increase mineral density and
bone quality, either as adjuvant treatments or as the treatment of choice.
Various research and clinical guidelines recommend the use of therapeutic exercise as part of
the treatment of osteoporosis. The National Osteoporosis Foundation of the United States
concludes that the practice of exercise improves, among other benefits, the quality of bone
mass. Likewise, different systematic reviews have shown that multicomponent training in older
people is effective in preventing or maintaining bone mass, especially when such exercises
are performed with high load or high impact or when performed by postmenopausal women.
Along these lines, the American College of Sports Medicine and recent research demonstrates
how strength work at moderate to high load intensity can not only stimulate bone metabolism,
but also improve the quality of life of those who practice it.
But in spite of the bone benefit observed with high loads for bone tissue, not all elderly
people can do it, either because of the fragility that many of them present, or because of
the mechanical stress that this type of exercise produces in their joints. For this reason,
one of the possible alternatives that we have found for some decades is training through the
use of global vibration (GV) or body vibration through the use of vibrating platforms. This
type of vibration generally starts in the extremities and the limbs themselves are used as a
sounding board for the vibrational stimulus to the rest of the body. This type of equipment
has allowed a less demanding training from the articular point of view in a less demanding
approach to other exercise programs in patients and has shown significant improvements in
bone formation rate, bone mineral density (BMD), trabecular structural and cortical thickness
in osteporotic bone tissue.
But despite the wide use of vibrating platforms for training in elderly people, it is not
free of contraindications such as patients with recent fracture, deep vein thrombosis,
osteosynthesis of lower limbs, hip prosthesis, aortic aneurysm or diabetic foot injury, for
this reason have emerged focal vibration devices (VF). This tool allows the application of
the vibratory stimulus in a specific and repeated way in a part of the body; as well as the
control of the amplitude that reaches a certain tissue avoiding the disadvantages of the
vibratory platforms in which the region and the tissue to be treated cannot be selected.
Description:
The high annual incidence of osteporosis (1% in women aged 65 years, 2% in women aged 75
years and 3% in women over 85 years) and its high prevalence (30% in postmenopausal women),
means that more and more resources are being devoted to its diagnosis, prevention and
treatment in primary care. According to the World Health Organization (WHO), this pathology
is defined as a skeletal disorder characterized by an alteration in bone strength, mainly
reflecting a poor integration of bone density and quality. Primary (or also known as
idiopathic) osteoporosis can affect both sexes, but postmenopausal and older women are more
vulnerable.
The reduction of the mass and the alteration of the microstructure of osteoporotic bone lead
to an increase in its fragility and an increase in the risk of suffering bone fractures. If
we add to this the alterations in balance observed in older people, the possibility of
fracture and increased fragility increases. It is estimated that every 3 seconds there is an
osteoporotic fracture and it is considered that every year 8.9 million fractures of this type
occur worldwide. Fragility fractures are estimated to be associated with significant
morbidity and mortality. In the case of hip fracture as a consequence of osteoporosis, only
30-45% of surviving cases recover pre-fracture functional status and 32-80% suffer some form
of significant dysfunction, thus representing a high economic and social cost.
Associated with osteoporosis, numerous studies have also observed a decrease in strength
and/or muscle mass (sarcopenia), thus increasing the fragility and deterioration of the
patient suffering from osteoporosis. Tokeshi et al. observed that patients with osteoporotic
fractures had less muscle mass compared to patients without osteoporosis. Hoo Lee and Sik
Gong describe that lower extremity muscle mass and loss of grip are closely related to the
occurrence of an osteoporotic vertebral fracture and numerous investigations show the
relationship between grip strength and osteoporotic fractures in the elderly.
For the diagnosis of osteoporosis, double beam X-ray densitometry (DEXA) is used and
osteoporosis is considered to be present when the osteoporosis values are below 2.5 standard
deviations (SD) of the peak bone mass, the maximum value reached in young women.
At the therapeutic level, pharmacology is the treatment recommended in clinical practice
guidelines. However, due to poor adherence and adverse effects, the recommendation of
physical activity programs is becoming more and more popular to increase mineral density and
bone quality, either as adjuvant treatments or as the treatment of choice.
Various research and clinical guidelines recommend the use of therapeutic exercise as part of
the treatment of osteoporosis. The National Osteoporosis Foundation of the United States
concludes that the practice of exercise improves, among other benefits, the quality of bone
mass. Likewise, different systematic reviews have shown that multicomponent training in older
people is effective in preventing or maintaining bone mass, especially when such exercises
are performed with high load or high impact or when performed by postmenopausal women.
Along these lines, the American College of Sports Medicine and recent research demonstrates
how strength work at moderate to high load intensity can not only stimulate bone metabolism,
but also improve the quality of life of those who practice it.
But in spite of the bone benefit observed with high loads for bone tissue, not all elderly
people can do it, either because of the fragility that many of them present, or because of
the mechanical stress that this type of exercise produces in their joints. For this reason,
one of the possible alternatives that we have found for some decades is training through the
use of global vibration (GV) or body vibration through the use of vibrating platforms. This
type of vibration generally starts in the extremities and the limbs themselves are used as a
sounding board for the vibrational stimulus to the rest of the body. This type of equipment
has allowed a less demanding training from the articular point of view in a less demanding
approach to other exercise programs in patients and has shown significant improvements in
bone formation rate, bone mineral density (BMD), trabecular structural and cortical thickness
in osteporotic bone tissue.
But despite the wide use of vibrating platforms for training in elderly people, it is not
free of contraindications such as patients with recent fracture, deep vein thrombosis,
osteosynthesis of lower limbs, hip prosthesis, aortic aneurysm or diabetic foot injury, for
this reason have emerged focal vibration devices (VF). This tool allows the application of
the vibratory stimulus in a specific and repeated way in a part of the body; as well as the
control of the amplitude that reaches a certain tissue avoiding the disadvantages of the
vibratory platforms in which the region and the tissue to be treated cannot be selected.
