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Completed

NCT Number: NCT06017245

The Bone-Myoregulation Reflex and Development of Sarcopenia in Osteoporosis

Bone and skeletal muscle are in a single unit that interacts with each other structurally and functionally. The aim of this study is to determine the contribution of bone myoregulation reflex as a neuronal crosstalk mechanism on the development of sarcopenia in postmenopausal and senile osteoporosis

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Key information

About this study

Bone and skeletal muscle are in a single unit that interacts with each other structurally and functionally. While myokines synthesized and released in skeletal muscle modulate the bone formation and destruction process, osteokines synthesized and released by bone cells have positive or negative effects on muscle (4,5,6,7,8,9). In addition to humoral crosstalk mechanisms between muscle and bone, there is also a neuronal crosstalk mechanism defined as bone myoregulation reflex. The aim of this study is to determine the contribution of bone myoregulation reflex as a neuronal crosstalk mechanism on the development of sarcopenia in postmenopausal and senile osteoporosis (10,11,12,13,14). Osteoporotic cases would be determined by standard DXA measurements.

The vibration will be applied with the PowerPlate® Pro5 whole-body vibration (London UK) device. The vibration amplitude will be 2 mm. The vibration frequency will be 30, 33, and 36 Hz. Each vibration frequency will be applied for 45 seconds. A 5-second rest period will be applied between vibrations of 45 seconds.

Surface EMG recordings will be taken from the right soleus muscle using the bipolar technique. A pair of self-adhesive Ag/AgCl (Redline®) electrodes will be adhered to the skin according to the SENIAM protocol(2). Recordings will be taken in the 1-500 Hz frequency band. Surface electromyography (EMG) recordings will be taken with a PowerLab ® (ADInstruments, Oxford, UK) data recorder with a sample rate of 20 KHz. EMG recordings will be analyzed offline with LabChart7 Pro® version 7.3.8 (ADInstruments, Oxford, UK). The acceleration measurement data will be recorded with the PowerLab (ADInstrument London) data acquisition simultaneously with the EMG recording. Acceleration recording will be made with a sample rate of 20 KHz.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • For healthy young adults control Healthy volunteers aged 20-45 years
  • For postmenopausal osteoporosis Hip DXA T-score (neck or total hip) < -2.5
  • For the Senile osteoporosis Over 65 years Male Hip DXA T-score (neck or total hip) < -2.5 Female

Exclusion criteria

  • Osteopenic cases
  • Possible sarcopenia (according to EWGSOP2 criteria)
  • Vertigo
  • Kidney stone
  • Panic attack story
  • Secondary osteoporosis
  • Those with polyneuropathy, central nervous system disease clinic/history
  • Myopathies (steroid, vitamin D deficiency, primary muscle diseases, etc.)
  • Cases with lesions on the soleus skin
  • History of fracture in lower extremity, joint prosthesis
  • Lower extremity active/acute thrombophlebitis

Treatment and study plan

whole-body vibration to Control

Device

Whole-body vibration (WBV) will be applied while standing upright. During this position, he will be asked not to voluntarily contract the calf muscles and to remain relaxed. The vibration will be applied with the PowerPlate® Pro5 WBV (London UK) device. The vibration amplitude will be 2 mm. The vibration frequency will be 30, 33, and 36 Hz. Each vibration frequency will be applied for 45 seconds. A 5-second rest period will be applied between vibrations of 45 seconds.

Primary outcomes

  1. Bone myoregulation reflex latency

    Time frame: up to 2 weeks

    It was defined as the period between the onset of effective mechanical stimulation and the onset of the reflex in surface electromyography.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

Could the Bone-Myoregulation Reflex Explain the Development of Sarcopenia in Postmenopausal and Senile Osteoporosis?

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2023
Registry last updated
Jan 17, 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.

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