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Bone Myoregulation Reflex in Senile Osteoporosis

Is the Bone Myoregulation Reflex Response to Weight-Bearing Activities Low in Senile Osteoporosis?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06786195
Enrollment
22
Registered
2025-01-22
Start date
2025-02-15
Completion date
2025-05-01
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis (Senile)

Keywords

Reflex, Vibration, Bone, Loading exercise, Osteoporosis

Brief summary

Osteoporosis is a systemic skeletal disease characterized by weakened and fragile bones. It often remains asymptomatic in its early stages but can lead to serious health problems, particularly fractures.The mechanostat theory explains that bone mass is regulated by mechanical loading. Increased activity stimulates bone formation, while decreased activity promotes bone resorption. The bone reflex concept further suggests that the nervous system plays a crucial role in this process by regulating both bone metabolism (osteoregulation) and muscle activity (myoregulation) in response to mechanical loading.

Detailed description

Background and Objectives:Osteoporosis is a systemic skeletal disease characterized by weakened and fragile bone tissue. Typically asymptomatic in its early stages, it can lead to severe health consequences, particularly fractures. Bone mineral density (BMD) measurements, as defined by the World Health Organization, are considered the gold standard for diagnosing osteoporosis. The prevalence of osteoporosis is on the rise due to the aging population and the influence of lifestyle factors. Recently, the bone reflex has been defined, suggesting that the central nervous system controls the local regulatory mechanisms described by Wolf and Frost. The bone reflex describes how osteocytes are stimulated by mechanical loading, leading to the neural regulation of bone formation and resorption according to mechanical needs (bone osteoregulation reflex). Additionally, it describes a mechanism by which the nervous system reflexively regulates the activity of surrounding muscles to optimally position the bone to resist applied mechanical load (bone myoregulation reflex). Methods: This study employs a quasi-experimental design. The study will be conducted with a total of 22 patients aged 60-70, men. Diagnosis of osteoporosis was made according to the World Health Organization classification. Individuals with a T-score of -2.5 or below were classified as having osteoporosis. Participants will be divided into two groups: a group with osteoporosis (Group 1) and a group without osteoporosis (Group 2). Procedures: Bone myoregulation reflex activity of the soleus and tibialis anterior muscles will be assessed in both groups during whole-body vibration and jumping using surface electromyography. * Jumping Test: Participants will be instructed to jump in place 20 times, similar to rope skipping, with a 5-second rest interval between each jump. * Whole-Body Vibration: Participants will stand on the plate and undergo low-amplitude (1.2 mm) whole-body vibration at eight different frequencies (25, 27, 29, 31, 33, 35, 37, and 39 Hz) using a Powerplate Pro5 (Netherlands) device. Each vibration session will last for 10 seconds, with a 5-second rest interval between frequencies. * The Achilles tendon will be percussed 10 times with an electronic reflex hammer.

Interventions

The subjects were first asked to jump in place 20 times, as if they were jumping rope. Then, whole-body vibration was applied. While the participants stood upright on the whole-body vibration device, low-amplitude (1.2 mm) vibrations were applied at eight different frequencies (25, 27, 29, 31, 33, 35, 37, 39 Hz), each lasting for 10 seconds, with a 5-second rest period in between. The Achilles tendon will be percussed 10 times with an electronic reflex hammer.

Sponsors

Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

This study employs a quasi-experimental design. Diagnosis of osteoporosis was made according to the World Health Organization classification. Individuals with a T-score of -2.5 or below were classified as having osteoporosis. Participants will be divided into two groups: a group with osteoporosis (Group 1) and a group without osteoporosis (Group 2).

Eligibility

Sex/Gender
MALE
Age
60 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* DXA T-scores ≤-2.5 (osteoporotic) or T-scores \> -1 (no bone loss) * Individuals who agree to participate in the study

Exclusion criteria

* History of musculoskeletal surgery within the past year * Individuals with health conditions that severely affect mobility * Vestibular disorders * Visual impairments * Other rheumatic, psychiatric, or severe neurological diseases * Chronic decompensated cardiac, renal, or hepatic insufficiency * Panic attacks * Individuals with skin lesions on the soleus muscle * History of fractures or prostheses in the lower extremities * History of kidney stones * 2+ or more edema in the lower extremities, lymphedema * History of malignancy * History of osteomalacia or vitamin D deficiency

Design outcomes

Primary

MeasureTime frameDescription
Bone myoregulation reflex latencyThrough study completion, an average of 8 weeks.The measurement will be taken as the time difference between the moment of mechanical stimulation and the onset of the reflex response in the EMG. The unit of measurement for latency is milliseconds.
Bereitschafts (Readiness) PotentialThrough study completion, an average of 8 weeks.It refers to the myoelectric activity in the tibialis anterior and soleus muscles just before jumping. The onset time of this myoelectric activity will be evaluated in milliseconds, and the amplitude of this activity will be measured in millivolts.

Secondary

MeasureTime frameDescription
Soleus H-reflexThrough study completion, an average of 8 weeksThe soleus T-reflex elicited by percussing the Achilles tendon with an electronic reflex hammer will be recorded using EMG. The unit of measurement for latency is milliseconds.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026