HealthyNCT06711835
Reflex Activity During Bone-Loading Exercises
A study testing Whole-body vibration and Jumping in people with Healthy, run by Eser Kalaoglu at 1 site in Turkey (Türkiye).
Trial summary
Load-bearing exercises are well-established as beneficial for bone health. Their role in promoting healthy bone development and managing osteoporosis is widely recognized. However, the neural mechanisms underlying the positive biomechanical effects of jumping-based load-bearing exercises, such as running, volleyball… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Whole-body vibration and Jumping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Individuals who cannot tolerate whole-body vibration
- Individuals with a history of neuromuscular disease
- Individuals with a history of skeletal disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul, 31180
About this study
Official title: Bereitschafts (Readiness) Potential and Reflex Activity During Bone-Loading Exercises
Load-bearing exercises are well-established as beneficial for bone health. Their role in promoting healthy bone development and managing osteoporosis is widely recognized. However, the neural mechanisms underlying the positive biomechanical effects of jumping-based load-bearing exercises, such as running, volleyball, basketball, tennis, and skipping rope, remain unclear. The aim of this study is to investigate whether jumping-based load-bearing exercises activate bone myoregulation reflex activity.
Read the 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.
- Conditions
- Healthy
- Being tested
- Whole-body vibration and Jumping
- Keywords
- Reflex, Vibration, Athletic Performance, Bone, Loading exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-body vibration and JumpingOther
Also called Loading exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Normally Active Individuals) | Experimental | Individuals with Normal Daily Activities Receives: Other: Whole-body vibration and Jumping |
| Group 2 (Athletic) | Experimental | Participants who regularly engage in sports activities such as marathon running, basketball, or volleyball Receives: Other: Whole-body vibration and Jumping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 8 weeks
Secondary outcomes (1)
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.
Measured: Through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Dec 2024
- Primary completion1 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study employs a quasi-experimental design. Participants will be divided into two groups based on their physical activity level: Group 1 (Normally Active Individuals), who engage in typical daily activities without regular sports participation, and Group 2 (Athletic Individuals), who regularly engage in athletic activities.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eser Kalaoglu
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Eser Kalaoglu, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- İlhan Karacan, Prof., Study director, Istanbul Physical Medicine Rehabilitation Training and Research HospitalEser Kalaoglu, M.D., Principal investigator, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711835
- Sponsor's protocol ID
- IstPRMTRH-EK1
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31942042Karacan I, Turker KS. Exploring neuronal mechanisms of osteosarcopenia in older adults. J Physiol. 2026 Jan;604(2):672-688. doi: 10.1113/JP285666. Epub 2024 Aug 9.
PubMed 39119811Ishikawa 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.
PubMed 23754172Zhang 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.
PubMed 28236603
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bereitschafts (Readiness) Potential and Reflex Activity During Bone-Loading Exercises
- ClinicalTrials.gov ID
- NCT06711835
- Acronym / sponsor ID
- IstPRMTRH-EK1
- Conditions
- Healthy
- Keywords
- Reflex, Vibration, Athletic Performance, Bone, Loading exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Eser KalaogluOther government
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Load-bearing exercises are well-established as beneficial for bone health. Their role in promoting healthy bone development and managing osteoporosis is widely recognized. However, the neural mechanisms underlying the positive biomechanical effects of jumping-based load-bearing exercises, such as running, volleyball, basketball, tennis, and skipping rope, remain unclear. The aim of this study is to investigate whether jumping-based load-bearing exercises activate bone myoregulation reflex activity.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study employs a quasi-experimental design. Participants will be divided into two groups based on their physical activity level: Group 1 (Normally Active Individuals), who engage in typical daily activities without regular sports participation, and Group 2 (Athletic Individuals), who regularly engage in athletic activities.
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Normally Active Individuals) | Experimental | Other: Whole-body vibration and JumpingIndividuals with Normal Daily Activities |
| Group 2 (Athletic) | Experimental | Other: Whole-body vibration and JumpingParticipants who regularly engage in sports activities such as marathon running, basketball, or volleyball |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Individuals who cannot tolerate whole-body vibration
- Individuals with a history of neuromuscular disease
- Individuals with a history of skeletal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-body vibration and JumpingAlso: Loading exerciseThe 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 | Group 1 (Normally Active Individuals), Group 2 (Athletic) |
Primary outcome
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.
1 secondary outcome
Bereitschafts (Readiness) Potential
Time frame: Through study completion, an average of 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Results publication: PubMed 31942042Yildirim 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.
- Results publication: PubMed 39119811Karacan I, Turker KS. Exploring neuronal mechanisms of osteosarcopenia in older adults. J Physiol. 2026 Jan;604(2):672-688. doi: 10.1113/JP285666. Epub 2024 Aug 9.
- Results publication: PubMed 23754172Ishikawa 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.
- Results publication: PubMed 28236603Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İlhan Karacan, Prof. study director
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Eser Kalaoglu, M.D. principal investigator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-body vibration and Jumping in people with Healthy, run by Eser Kalaoglu at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone myoregulation reflex latency (time frame: Through study completion, an average of 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06711835, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.