NCT07253493

Brief Summary

Weight-bearing exercises (e.g., running, jumping, whole-body vibration) are widely practiced due to their beneficial effects on bone development and their role in the prevention and treatment of osteoporosis. However, the underlying neuroregulatory mechanisms responsible for these positive effects have not yet been fully understood. Two main neuromodulatory mechanisms have been proposed in the literature: (i) spinal reflexes originating from muscle spindles (stretch reflex, tonic vibration reflex), and (ii) the bone myoregulation reflex (BMR) based on load-sensitive osteocytes. It is well established that increased voluntary contraction and the associated rise in background EMG activity, that is, motor neuron pool activity, enhance muscle spindle-based reflex responses (such as the H-reflex and tendon reflex). In contrast, it has been demonstrated that the H-reflex is suppressed during bone-loading activities such as single-leg stance, jumping, or whole-body vibration. This study is based on two hypotheses:

  • As mechanical loading increases, Ia inhibitory effects intensify, leading to greater H-reflex suppression.
  • During whole-body vibration, the H-reflex is suppressed due to Ia inhibition. If this inhibition originates from load-sensitive receptors-osteocytes-and thus from the BMR, then in osteoporosis, where osteocyte number and function are reduced, H-reflex suppression will be diminished. The aim of this research is to test these hypotheses. Confirmation of these assumptions would suggest that reflex control during weight-bearing exercise occurs predominantly through osteocyte-mediated BMR mechanisms rather than muscle spindle-based mechanisms such as the stretch or tonic vibration reflex.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

November 19, 2025

Last Update Submit

November 19, 2025

Conditions

Keywords

H-reflexosteoporosiswhole-body vibrationmechanical loadosteocytebone myoregulation reflexbackground EMG activity

Outcome Measures

Primary Outcomes (1)

  • H-reflex Amplitude

    H reflex will be measured 10 times each in 5 different mechanical loads and during 1 minute whole-body vibration. Average amplitude of 10 measurements will be calculated.

    During the day of testing

Secondary Outcomes (1)

  • Bone myoregulation reflex latency

    During the day of testing

Study Arms (2)

Postmenapausal femoral osteoporosis

OTHER

Subjects with diagnosed femoral osteoporosis will be in this arm. Femoral osteoporosis is defined as T-scores of -2.5 or lower in femoral neck or total femur obtained in dual energy x-ray absorptiometry. Subjects will have their H-reflex amplitude measured in 6 different settings and will be applied 10 seconds whole-body vibration in 4 different frequencies to measure bone mroregulation reflex.

Diagnostic Test: H-reflexDiagnostic Test: Bone myoregulation reflex

Healthy control

OTHER

Subjects who do not have osteoporosis or osteopenia will be in this arm. Subjects in this group will have L1-L4, L2-L4, femoral neck and total femur T-scores of greater than -1 obtained in dual energy x-ray absorptiometry. Subjects will have their H-reflex amplitude measured in 6 different settings and will be applied 10 seconds whole-body vibration in 4 different frequencies to measure bone mroregulation reflex.

Diagnostic Test: H-reflexDiagnostic Test: Bone myoregulation reflex

Interventions

H-reflexDIAGNOSTIC_TEST

H-reflex will be measured during 5 different mechanical loads and whole body vibration.

Also known as: Hoffmann's reflex
Healthy controlPostmenapausal femoral osteoporosis

Bone myoregulation reflex will be measured by applying 10 seconds whole body vibration of 4 different frequencies.

Healthy controlPostmenapausal femoral osteoporosis

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being in the postmenopausal period
  • For the osteoporosis group: having femoral osteoporosis (femoral neck or total femur T-score ≤ -2.5)
  • For the control group: having no osteoporosis or osteopenia (femoral neck and total femur T-scores \> -1, and L1-L4 and L2-L4 T-scores \> -1)
  • Being a volunteer

You may not qualify if:

  • Receiving osteoporosis treatment
  • Having a peripheral or central nervous system disorder (e.g., stroke, polyneuropathy, radiculopathy, entrapment neuropathy, etc.)
  • Having acquired or hereditary muscle diseases (myopathies)
  • Having active painful lower extremity pathologies (e.g., osteoarthritis, inflammatory joint diseases, etc.)
  • Having cardiac arrhythmias
  • Having a history of other metabolic bone diseases
  • Having skin lesions at the electrode placement sites on the lower extremities
  • Being older than 65 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Bahçelievler, Istanbul, 34180, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoporosis, PostmenopausalOsteoporosis

Interventions

H-Reflex

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Reflex, MonosynapticReflexNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • İlhan Karacan, Prof. Dr.

    stanbul Physical Medicine Rehabilitation Training and Research Hospital

    STUDY CHAIR

Central Study Contacts

Fuat Orhun Alayoğlu, Attending doctor

CONTACT

İlhan Karacan, Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessor and statistician will be blinded to the groups of participants.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

November 19, 2025

First Posted

November 28, 2025

Study Start

November 18, 2025

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

All collected data will be shared

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
For 5 years after the publication date
Access Criteria
The individual participant data (IPD) that support the findings of this study will be available from the corresponding author upon reasonable request and with permission of the Istanbul Physical Medicine and Rehabilitation Training and Research Hospital Ethics Committee. Data will be anonymized prior to sharing.
More information

Locations