The Bone-Myoregulation Reflex and Development of Sarcopenia in Osteoporosis

Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06017245
Collaborator
(none)
80
3
17

Study Details

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
  • Device: whole-body vibration to Control
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
80 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?
Anticipated Study Start Date :
Aug 29, 2023
Anticipated Primary Completion Date :
Sep 8, 2023
Anticipated Study Completion Date :
Sep 15, 2023

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

  1. Bone myoregulation reflex latency [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

Criteria

Ages Eligible for Study:
20 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

No locations specified.

Sponsors and Collaborators

  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT06017245
Other Study ID Numbers:
  • BMROPS
First Posted:
Aug 30, 2023
Last Update Posted:
Aug 30, 2023
Last Verified:
Aug 1, 2023
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 30, 2023