search
Back to results

The Bone-Myoregulation Reflex and Development of Sarcopenia in Osteoporosis

Primary Purpose

Sarcopenia, Osteoporosis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
whole-body vibration to Control
Sponsored by
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sarcopenia focused on measuring muscle strength, bone mineral density

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ilhan KaracanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control

Senile osteoporosis

Postmenopausal osteoporosis

Arm Description

Healthy young-adult groups

Patients with senile osteoporosis

Patients with postmenopausal osteoporosis

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 24, 2023
Last Updated
September 24, 2023
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT06017245
Brief Title
The Bone-Myoregulation Reflex and Development of Sarcopenia in Osteoporosis
Official Title
Could the Bone-Myoregulation Reflex Explain the Development of Sarcopenia in Postmenopausal and Senile Osteoporosis?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 29, 2023 (Actual)
Primary Completion Date
October 20, 2023 (Anticipated)
Study Completion Date
November 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Osteoporosis
Keywords
muscle strength, bone mineral density

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Healthy young-adult groups
Arm Title
Senile osteoporosis
Arm Type
Experimental
Arm Description
Patients with senile osteoporosis
Arm Title
Postmenopausal osteoporosis
Arm Type
Experimental
Arm Description
Patients with postmenopausal osteoporosis
Intervention Type
Device
Intervention Name(s)
whole-body vibration to Control
Intervention Description
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 Outcome Measure Information:
Title
Bone myoregulation reflex latency
Description
It was defined as the period between the onset of effective mechanical stimulation and the onset of the reflex in surface electromyography.
Time Frame
up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ILHAN KARACAN, MD
Phone
+905327005361
Email
mdkaracanilhan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
TUGBA AYDIN, MD
Phone
+905324622162
Email
drtugbaaydin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TUGBA AYDIN, MD
Organizational Affiliation
İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ilhan Karacan
City
Istanbul
State/Province
Kocaeli
ZIP/Postal Code
34303
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
İLHAN KARACAN, MD
Phone
05327005361
Email
mdkaracanilhan@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
11018445
Citation
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.
Results Reference
background
PubMed Identifier
25100978
Citation
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.
Results Reference
background
PubMed Identifier
31081853
Citation
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.
Results Reference
background
PubMed Identifier
28457998
Citation
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.
Results Reference
background
PubMed Identifier
25551934
Citation
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.
Results Reference
background

Learn more about this trial

The Bone-Myoregulation Reflex and Development of Sarcopenia in Osteoporosis

We'll reach out to this number within 24 hrs