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OsteoporosisNCT05538377

Effect of Focal Vibration Within a Multicomponent Exercise Program for Older Women With Osteoporosis a Single-blind Clinical Trial

A study testing Focal Vibration in people with Osteoporosis and Osteoporosis, Postmenopausal, run by Universitat Internacional de Catalunya at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 60 to 75 years, women only
Conditions the study is for
Osteoporosis, Osteoporosis, Postmenopausal
What is being tested?
Focal Vibration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteSpain
Study dates
1 Dec 2022to 1 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Universitat Internacional de Catalunya

    Sant Cugat del Vallès, Barcelona, 08195

Other trials in Spain

About this study

Official title: Effect of Focal Vibration on Bone Quality Within a Multicomponent Exercise Program for Older Women With Osteoporosis a Single-blind Clinical Trial

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.

Read more

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.

Read the 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.

Being tested
Focal Vibration, Control Group
Medical subject headings
Osteoporosis, Osteoporosis, Postmenopausal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Focal VibrationOther

    This group will receive a multicomponent exercise program based on specific literature for effective training. In addition, this group will perform the strength and endurance exercises with focal vibration on the vastus internus, externus and biceps femoris. There will be 2 sessions per week, with a duration of 60 minutes per session and a treatment duration of 6 months.

  • Control GroupOther

    This group will receive the same multicomponent exercise program than the other group based on specific literature for effective training. There will be 2 sessions per week, with a duration of 60 minutes per session and a treatment duration of 6 months.

Study groups in NCT05538377
Study groupRoleWhat they receive
Focal VibrationExperimentalNot described
Receives: Other: Focal Vibration
Control GroupActive comparatorNot described
Receives: Other: Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in bone mineral density (mg/cm3)

    Bone mineral density will be analyzed by radiological densitometry using quantitative ultrasound. This technique is completely harmless to the patient and has been shown in numerous investigations to predict the risk of osteoporotic fractures.

    Measured: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up

Secondary outcomes (10)
  1. Senior Fitness test (questionnaire)

    Consists of a battery of tests specifically designed for the elderly population to assess their functional condition to perform normal activities of daily living safely, independently and without excessive fatigue.

    Measured: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up

  2. 30-m walk test (seconds)

    The maximum walking speed will be measured by the 30-m walk test, which measures the time spent walking 30 m as fast as possible without running.

    Measured: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up

  3. Chair stand test (attempts)

    Lower extremity strength will be measured with the chair stand test, which will measure the number of times the person can stand up and sit down in a chair in 30 s.

    Measured: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up

  4. Arm curl test (attempts)

    Upper extremity strength was measured with the arm curl test, in which the elderly had to lift a 4 kg (men) or 2.5 kg (women) dumbbell to the maximum number of repetitions in 30 s.

    Measured: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up

  5. Maximum isometric strength (Newtons)

    Maximum isometric strength of the lower and upper extremity will be assessed using a manual dynamometer.

    Measured: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up

  6. Handgrip (Newtons)

    The participant must squeeze the dynamometer as hard as possible and the force applied will be recorded.

    Measured: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up

  7. Balance Surface (mm2)

    The surface comprises 95% of all the measured points of the center of pressures. It is measured in square millimeters. A larger surface area of the ellipse implies a lower capacity to maintain equilibrium at the center of pressure.

    Measured: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up

  8. Balance length (mm)

    It is measured in millimeters, and assesses the accuracy of the fine postural system in maintaining balance. A longer stabilogram length indicates a greater involvement of the fine control system in rebalancing.

    Measured: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up

  9. Frail Scale

    Is a 5-item questionnaire that measures fatigue (in the last 4 weeks), endurance (being able to climb 10 steps without resting), ambulation (having some difficulty walking hundreds of meters), illness and body weight loss during the last year.

    Measured: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up

  10. SF-36 (questionnaire 0-100)

    The items are coded, aggregated and transformed into a scale ranging from 0 (the worst health status for that dimension) to 100 (the best health status).

    Measured: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2022
  2. Study start1 Dec 2022 (estimated)
  3. Primary completion1 Apr 2024 (estimated)
  4. Study completion1 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05538377
Sponsor's protocol ID
CFC22OST
Status last verified
Sep 2022
First submitted
8 Sep 2022
Last updated
16 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Focal Vibration in people with Osteoporosis and Osteoporosis, Postmenopausal, run by Universitat Internacional de Catalunya at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in bone mineral density (mg/cm3) (time frame: Baseline; 6 months follow-up; 9 month follow-up; 1 year follow-up; 15 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.

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