- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06711835
Reflex Activity During Bone-Loading Exercises
Bereitschafts (Readiness) Potential and Reflex Activity During Bone-Loading Exercises
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background and Objectives: Wolff was the first to propose that the microarchitectural structure and mechanical resistance of bone are remodeled in response to mechanical loads it experiences. Frost further expanded on this concept with the mechanostat theory, suggesting that bone formation and resorption remain in balance during routine daily activities. Decreased activity leads to increased bone resorption, while increased activity stimulates bone formation. Consequently, the microarchitectural structure and strength of bone weaken or strengthen accordingly. Recently, the bone reflex has been defined, suggesting that the central nervous system controls the local regulatory mechanisms described by Wolff and Frost. The bone reflex describes how osteocytes are stimulated by mechanical loading, leading to the neural regulation of bone formation and resorption according to mechanical needs (bone osteoregulation reflex). Additionally, it describes a mechanism by which the nervous system reflexively regulates the activity of surrounding muscles to optimally position the bone to resist applied mechanical load (bone myoregulation reflex).
Load-bearing exercises are well-established as beneficial for bone health, with their role in promoting healthy bone development and managing osteoporosis being widely recognized. However, the neural mechanisms underlying the positive biomechanical effects of jumping-based load-bearing exercises, such as running, volleyball, basketball, tennis, and rope skipping, remain unclear. The aim of this study is to investigate whether jumping-based load-bearing exercises activate bone myoregulation reflex activity.
Methods: The study will be conducted with a total of 40 healthy volunteers aged 20-50, comprising both women and men. Participants will be recruited from individuals who either regularly engage in jumping-based sports activities (e.g., volleyball, marathon running, and tennis) or those who perform typical daily living activities without regular sports engagement. Participants will be divided into two groups based on their activity levels: Group 1 (Normally Active Individuals) and Group 2 (Athletic Individuals).
Procedures:
Bone myoregulation reflex activity of the soleus and tibialis anterior muscles will be assessed in both groups during whole-body vibration and jumping using surface electromyography.
- Jumping Test: Participants will be instructed to jump in place 20 times, similar to rope skipping, with a 5-second rest interval between each jump.
- Whole-Body Vibration: Participants will stand on the plate and undergo low-amplitude (1.2 mm) whole-body vibration at eight different frequencies (25, 27, 29, 31, 33, 35, 37, and 39 Hz) using a Powerplate Pro5 (Netherlands) device. Each vibration session will last for 10 seconds, with a 5-second rest interval between frequencies.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey, 31180
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age: Between 20-50 years old
- Gender: Male or female
- Health status: Good general health
- Physical activity: Normally Active Individuals or Regularly engaging in jumping sports activities such as volleyball, marathon, or tennis, or not engaging in such activities
Exclusion Criteria:
- Individuals who cannot tolerate whole-body vibration
- Individuals with a history of neuromuscular disease
- Individuals with a history of skeletal disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1 (Normally Active Individuals)
Individuals with Normal Daily Activities
|
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.
Other Names:
|
|
Experimental: Group 2 (Athletic)
Participants who regularly engage in sports activities such as marathon running, basketball, or volleyball
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone myoregulation reflex latency
Time Frame: Through study completion, an average of 8 weeks
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bereitschafts (Readiness) Potential
Time Frame: Through study completion, an average of 8 weeks
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: İlhan Karacan, Prof., Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Principal Investigator: Eser Kalaoglu, M.D., Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Publications and helpful links
General Publications
- Yildirim MA, Topkara B, Aydin T, Paker N, Soy D, Coskun E, Ones K, Bardak A, Kesiktas N, Ozyurt MG, Celik B, Onder B, Kilic A, Kucuk HC, Karacan I, Turker KS. Exploring the receptor origin of vibration-induced reflexes. Spinal Cord. 2020 Jun;58(6):716-723. doi: 10.1038/s41393-020-0419-5. Epub 2020 Jan 15.
- 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.
- Ishikawa S, Kim Y, Kang M, Morgan DW. Effects of weight-bearing exercise on bone health in girls: a meta-analysis. Sports Med. 2013 Sep;43(9):875-92. doi: 10.1007/s40279-013-0060-y.
- Zhang L, Miramini S, Richardson M, Ebeling P, Little D, Yang Y, Huang Z. Computational modelling of bone fracture healing under partial weight-bearing exercise. Med Eng Phys. 2017 Apr;42:65-72. doi: 10.1016/j.medengphy.2017.01.025. Epub 2017 Feb 22.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IstPRMTRH-EK1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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