Bone Myoregulation Reflex in Senile Osteoporosis

NCT06786195 | Completed

• 1 other identifier: IstPRMTRH-EK2
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoporosis is a systemic skeletal disease characterized by weakened and fragile bones. It often remains asymptomatic in its early stages but can lead to serious health problems, particularly fractures.The mechanostat theory explains that bone mass is regulated by mechanical loading. Increased activity stimulates bone formation, while decreased activity promotes bone resorption. The "bone reflex" concept further suggests that the nervous system plays a crucial role in this process by regulating both bone metabolism (osteoregulation) and muscle activity (myoregulation) in response to mechanical loading.

Conditions

Osteoporosis (Senile)

Keywords

Reflex; Vibration; Bone; Loading exercise; Osteoporosis

Outcome Measures

Primary Outcomes (2)

• Bone myoregulation reflex latency

  The measurement will be taken as the time difference between the moment of mechanical stimulation and the onset of the reflex response in the EMG. The unit of measurement for latency is milliseconds.

  Through study completion, an average of 8 weeks.

• Bereitschafts (Readiness) Potential

  It refers to the myoelectric activity in the tibialis anterior and soleus muscles just before jumping. The onset time of this myoelectric activity will be evaluated in milliseconds, and the amplitude of this activity will be measured in millivolts.

  Through study completion, an average of 8 weeks.

Secondary Outcomes (1)

• Soleus H-reflex

  Through study completion, an average of 8 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Those with osteoporosis

Other: Whole-body vibration and Jumping

Group 2

EXPERIMENTAL

Those without osteoporosis

Other: Whole-body vibration and Jumping

Interventions

Whole-body vibration and Jumping OTHER

The subjects were first asked to jump in place 20 times, as if they were jumping rope. Then, whole-body vibration was applied. While the participants stood upright on the whole-body vibration device, low-amplitude (1.2 mm) vibrations were applied at eight different frequencies (25, 27, 29, 31, 33, 35, 37, 39 Hz), each lasting for 10 seconds, with a 5-second rest period in between. The Achilles tendon will be percussed 10 times with an electronic reflex hammer.

Group 1; Group 2

Eligibility Criteria

• Age: 60 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DXA T-scores ≤-2.5 (osteoporotic) or T-scores \> -1 (no bone loss)
• Individuals who agree to participate in the study

You may not qualify if:

• History of musculoskeletal surgery within the past year
• Individuals with health conditions that severely affect mobility
• Vestibular disorders
• Visual impairments
• Other rheumatic, psychiatric, or severe neurological diseases
• Chronic decompensated cardiac, renal, or hepatic insufficiency
• Panic attacks
• Individuals with skin lesions on the soleus muscle
• History of fractures or prostheses in the lower extremities
• History of kidney stones
• + or more edema in the lower extremities, lymphedema
• History of malignancy
• History of osteomalacia or vitamin D deficiency

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Therapy Rehabilitation Training and Research Hospital

Istanbul, 34186, Turkey (Türkiye)

Location

Related Publications (6)

• Kalaoglu E, Faruk Bucak O, Kokce M, Ozkan M, Cetin M, Atasoy M, Ayture L, Karacan I. High-frequency whole-body vibration activates tonic vibration reflex. Turk J Phys Med Rehabil. 2023 Jan 11;69(1):46-51. doi: 10.5606/tftrd.2023.10854. eCollection 2023 Mar.

  PMID: 37201009 BACKGROUND

• 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

• Kilic A, Soyturk G, Karaoglu A, Topkara Arslan B, Karacan I, Turker KS. A reliability study on the cumulative averaging method for estimating effective stimulus time in vibration studies. J Electromyogr Kinesiol. 2023 Jun;70:102768. doi: 10.1016/j.jelekin.2023.102768. Epub 2023 Mar 20.

  PMID: 36965288 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

• Karacan I, Turker KS. Exploring neuronal mechanisms of osteosarcopenia in older adults. J Physiol. 2024 Aug 9. doi: 10.1113/JP285666. Online ahead of print.

  PMID: 39119811 BACKGROUND

• Kanis JA. Assessment of fracture risk and its application to screening for postmenopausal osteoporosis: synopsis of a WHO report. WHO Study Group. Osteoporos Int. 1994 Nov;4(6):368-81. doi: 10.1007/BF01622200.

  PMID: 7696835 BACKGROUND

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study employs a quasi-experimental design. Diagnosis of osteoporosis was made according to the World Health Organization classification. Individuals with a T-score of -2.5 or below were classified as having osteoporosis. Participants will be divided into two groups: a group with osteoporosis (Group 1) and a group without osteoporosis (Group 2).

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 22, 2025
• Study Start: February 15, 2025
• Primary Completion: April 15, 2025
• Study Completion: May 1, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

TU (1)