NCT05478447

Brief Summary

Whole body vibration (WBV) is a therapeutic modality in the form of exercise on a vibrating platform with an amplitude of 2-4 mm at a frequency of 25-50 Hz, which is used with increased popularity in sports medicine and rehabilitation due to its beneficial effects on muscle strength, balance, postural control, bone formation, and circulation. Beneficial effects on muscle strength and athletic performance have been reported. Spinal reflexes explain these beneficial neuromuscular effects. However, the neuronal circuit and receptors of the reflex response have not been defined precisely. A group of researchers propose that the reflex system underlying the neuromuscular effects of WBV is the Tonic vibration reflex (TVR), whose receptor is the muscle spindle; other researchers claim that the reflex latency induced by WBV is 4-5 ms longer than the TVR latency, so it is a bone myoregulation reflex whose receptor is osteocytes. The muscle spindle has sympathetic innervation. It has been reported that in case of increased sympathetic activity, muscle spindle sensitivity may increase and short-latency stretch reflex may be facilitated. The variation of muscle spindle activity with sympathetic activity may provide an opportunity to define the nature of the reflex response during WBV. Muscle spindles are more sensitive to vibrations around 100 Hz. This study has two hypotheses: According to the first hypothesis, WBV activates muscle spindles and the reflex latency induced by WBV is the same as TVR latency, and the latency does not change with increased sympathetic activity. According to the alternative hypothesis, WBV activates osteocytes, and WBV-induced reflex latency is longer than TVR latency. With increased sympathetic activity, the WBV reflex becomes dominant and the WBV-induced reflex latency becomes shorter. The aim of this research is to determine which of these two hypotheses is valid.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 9, 2022

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

20 days

First QC Date

July 26, 2022

Last Update Submit

October 11, 2022

Conditions

Keywords

tonic vibration reflexvibrationwhole body vibrationsympathetic activation

Outcome Measures

Primary Outcomes (2)

  • Whole-body vibration (WBV) induced reflex latency

    Latency of the soleus reflex response induced by WBV. Its unit is milliseconds

    during intervention, an average of 3 minute

  • Tendon vibration induced reflex latency

    Vibration will be applied to the achilles tendon. The soleus reflex latency induced by the tendon vibration will be measured. Its unit is milliseconds

    during intervention, an average of 3 minute

Secondary Outcomes (2)

  • Heart rate variability

    during intervention, an average of 2 hours

  • Sympathetic skin response

    during intervention, an average of 2 hours

Study Arms (1)

Vibration group

EXPERIMENTAL

Vibration (WBV, and tendon vibration) and sympathetic activation maneuvers will be applied to participants

Procedure: Vibration

Interventions

VibrationPROCEDURE

whole-body vibration, and tendon vibrations will be applied to the human body

Also known as: whole body vibration, tendon vibration, sympathetic activation maneuver
Vibration group

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being healthy
  • Being a young adult (20-45 years old)
  • Volunteer
  • Male

You may not qualify if:

  • Scar, dermatitis, etc. in the skin tissue where EMG electrodes will be placed
  • Kidney stone history
  • Fracture in the lower extremity, history of orthopedic surgery
  • Heart disease, Hypertension
  • Dizziness
  • Metabolic bone diseases, including osteoporosis
  • History of bone occupying lesion, neoplasia, osteomyelitis
  • Degenerative, inflammatory diseases of the joints of the lower extremities
  • Lower extremity thrombophlebitis
  • Lower extremity motor loss, sensory loss, muscle atrophy
  • Cold allergy
  • Subjects who cannot tolerate whole-body vibration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Istanbul, 34173, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Vibration

Intervention Hierarchy (Ancestors)

Mechanical PhenomenaPhysical Phenomena

Study Officials

  • İlhan Karacan, Assoc Prof

    Istanbul Physical Medicine Rehabilitation Training & Research Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 26, 2022

First Posted

July 28, 2022

Study Start

September 9, 2022

Primary Completion

September 29, 2022

Study Completion

September 30, 2022

Last Updated

October 13, 2022

Record last verified: 2022-10

Locations