Clinical trial NCT05538377: Effect of Focal Vibration Within a Multicomponent Exercise Program for Older Women With Osteoporosis a Single-blind Clinical Trial
Official title: Effect of Focal Vibration on Bone Quality Within a Multicomponent Exercise Program for Older Women With Osteoporosis a Single-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoporosis
Osteoporosis, Postmenopausal
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 34
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* A woman between 60 and 75 years of age with a medical diagnosis of osteoporosis by means of a femur or lumbar densitometry of less than 2.5 standard deviations (SD) of peak bone mass.
* No history of previous fracture in the last 10 years.

Exclusion Criteria:

* Secondary osteoporosis.
* Having suffered a bone fracture in the last year.
* Having had juvenile osteoporosis during adolescence or young adulthood.
* Uncontrolled arterial hypertension.
* Uncontrolled orthostatic hypotension.
* Severe acute respiratory failure.
* Diabetes mellitus with acute decompensation or uncontrolled hypoglycemia.
* Endocrine, hematological and other associated rheumatic diseases.
* Mental health problems (schizophrenia, dementia, depression, etc.) or not being in full mental capacity.
* Patients with pharmacological treatments of glucocorticoids, anticoagulants and/or diuretics.
* Patients with coagulation problems or previous cardiac pathology.
* People with a body mass index (BMI) equal to or higher than 30.
* Subjects who present a systemic disease or any other pathology in which therapeutic exercise could be contraindicated.

Primary outcomes:
measure: Change in bone mineral density (mg/cm3)
timeFrame: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up
Secondary outcomes:
measure: Senior Fitness test (questionnaire)
timeFrame: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up
measure: 30-m walk test (seconds)
timeFrame: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up
measure: Chair stand test (attempts)
timeFrame: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up
measure: Arm curl test (attempts)
timeFrame: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up
measure: Maximum isometric strength (Newtons)
timeFrame: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up
measure: Handgrip (Newtons)
timeFrame: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up
measure: Balance Surface (mm2)
timeFrame: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up
measure: Balance length (mm)
timeFrame: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up
measure: Frail Scale
timeFrame: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up
measure: SF-36 (questionnaire 0-100)
timeFrame: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up
Other outcomes:
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
References: