The Bone-Myoregulation Reflex and Development of Sarcopenia in Osteoporosis

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ClinicalTrials.gov Identifier: NCT06017245

Recruitment Status : Completed

First Posted : August 30, 2023

Last Update Posted : January 17, 2024

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Sponsor:

Information provided by (Responsible Party):

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Sarcopenia Osteoporosis	Device: whole-body vibration to Control	Not Applicable

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Basic Science
Official Title:	Could the Bone-Myoregulation Reflex Explain the Development of Sarcopenia in Postmenopausal and Senile Osteoporosis?
Actual Study Start Date :	August 29, 2023
Actual Primary Completion Date :	December 20, 2023
Actual Study Completion Date :	December 29, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Control Healthy young-adult groups	Device: whole-body vibration to Control 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.
Experimental: Senile osteoporosis Patients with senile osteoporosis	Device: whole-body vibration to Control 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.
Experimental: Postmenopausal osteoporosis Patients with postmenopausal osteoporosis	Device: whole-body vibration to Control 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.

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06017245

Locations

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Turkey
Ilhan Karacan
Istanbul, Kocaeli, Turkey, 34303

Sponsors and Collaborators

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

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Principal Investigator:	TUGBA AYDIN, MD	İstanbul Physical Therapy Rehabilitation Training & Research Hosptial

More Information

Publications:

Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.

Karacan I, Cakar HI, Sebik O, Yilmaz G, Cidem M, Kara S, Turker KS. A new method to determine reflex latency induced by high rate stimulation of the nervous system. Front Hum Neurosci. 2014 Jul 18;8:536. doi: 10.3389/fnhum.2014.00536. eCollection 2014.

Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.

Karacan I, Cidem M, Cidem M, Turker KS. Whole-body vibration induces distinct reflex patterns in human soleus muscle. J Electromyogr Kinesiol. 2017 Jun;34:93-101. doi: 10.1016/j.jelekin.2017.04.007. Epub 2017 Apr 24.

Karamehmetoglu SS, Karacan I, Cidem M, Kucuk SH, Ekmekci H, Bahadir C. Effects of osteocytes on vibration-induced reflex muscle activity in postmenopausal women. Turk J Med Sci. 2014;44(4):630-8.

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Responsible Party:	Istanbul Physical Medicine Rehabilitation Training and Research Hospital
ClinicalTrials.gov Identifier:	NCT06017245
Other Study ID Numbers:	BMROPS
First Posted:	August 30, 2023 Key Record Dates
Last Update Posted:	January 17, 2024
Last Verified:	January 2024

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Istanbul Physical Medicine Rehabilitation Training and Research Hospital:


muscle strength bone mineral density

Additional relevant MeSH terms:

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Osteoporosis Sarcopenia Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases	Muscular Atrophy Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Atrophy Pathological Conditions, Anatomical

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