The Bone-Myoregulation Reflex and Development of Sarcopenia in Osteoporosis

NCT06017245 | Completed

• 1 other identifier: BMROPS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Sarcopenia; Osteoporosis

Keywords

muscle strength; bone mineral density

Outcome Measures

Primary Outcomes (1)

• Bone myoregulation reflex latency

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

  up to 2 weeks

Study Arms (3)

Control

ACTIVE COMPARATOR

Healthy young-adult groups

Device: whole-body vibration to Control

Senile osteoporosis

EXPERIMENTAL

Patients with senile osteoporosis

Device: whole-body vibration to Control

Postmenopausal osteoporosis

EXPERIMENTAL

Patients with postmenopausal osteoporosis

Device: whole-body vibration to Control

Interventions

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.

Control; Postmenopausal osteoporosis; Senile osteoporosis

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Ilhan Karacan

Istanbul, Kocaeli, 34303, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 11018445 BACKGROUND

• 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.

  PMID: 25100978 BACKGROUND

• 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.

  PMID: 31081853 BACKGROUND

• 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.

  PMID: 28457998 BACKGROUND

• 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.

  PMID: 25551934 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Osteoporosis

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• TUGBA AYDIN, MD

  İstanbul Physical Therapy Rehabilitation Training & Research Hosptial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 30, 2023
• Study Start: August 29, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 29, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

TU (1)