Health AdultsNCT07245225
Acute Effects of High Impact Exercise on Bone Metabolism
A study testing Exercise in people with Health Adults, run by Loughborough University at 1 site in United Kingdom.
Trial summary
The goal of this study is to investigate the acute effects of drop-landing exercise on the bone metabolism biomarkers and extracellular vesicles in healthy young males, in order to gain a deeper understanding of the mechanotransduction mechanisms involved in bone metabolism. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Health Adults
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 years old
- Healthy
- Male
- Body mass index (BMI) of 18.5-29.9
- Can understand and follow trial instructions
Who cannot join
- Have any uncontrolled cardiovascular or respiratory disease
- Have severe musculoskeletal or neurological disease likely to affect ability to perform an exercise
- Have medical conditions known to affect musculoskeletal health
- Have medications known to affect bone metabolism (e.g., corticosteroids, thyroxine, antiepileptic, and antiretroviral agents)
- Regular (more than once per week) participation in high-intensity resistance or impact-type exercise in the past 6 months
- Current smoker or vaper
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Loughborough University
Loughborough, Leicestershire, LE11 3TU
About this study
The goal of this study is to investigate the acute effects of drop-landing exercise on the bone metabolism biomarkers and extracellular vesicles in healthy young males, in order to gain a deeper understanding of the mechanotransduction mechanisms involved in bone metabolism.
The main question aims to answer:
Read more
- Does a single bout acute drop-landing exercise change serum sclerostin, other bone signaling markers, and circulating extracellular vesicles levels?
Participants complete both the drop-landing and control trials in a randomized order, with a minimum washout period of one week between trials. During each trial, blood samples are collected at three time points: pre-, immediately post, and 1-hour post drop-landing/control exercise.
- Conditions
- Health Adults
- Being tested
- Exercise
- Keywords
- Exercise, Bone turnover, Extracellular vesicles, Wnt/β-catenin signaling pathway
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
During the drop-landing trial, participants perform drop-landing exercises from a block calibrated to generate approximately four times their body weight in vertical ground reaction force upon landing, employing a stiff-landing technique. Each repetition is separated by a 30-second interval, and 10 repetitions are performed as 1 set, totalling 6 sets. There is a 2-minute rest break between each set, during which the participants are asked to sit on a chair. The entire drop-landing exercise is recorded on the force plate.
During the control trial, participants are required to walk up and down from the same height block without the requirement to perform the drop-landing movement. The number of repetitions, intervals, and rest breaks are completely consistent with the drop-landing exercise.
| Study group | Role | What they receive |
|---|---|---|
| Arm Drop-landing + Control | Experimental | According to the results of random allocation, participants first perform the drop-landing trial, followed by the control trial, with a minimum interval of one week between the two trials. Receives: Behavioral: Exercise |
| Arm Control + Drop-landing | Experimental | According to the results of random allocation, participants first perform the control trial, followed by the drop-landing trial, with a minimum interval of one week between the two trials. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum sclerostin concentration
Serum sclerostin concentration is quantified using an enzyme-linked immunosorbent assay (ELISA) and reported in picograms per milliliter (pg/mL).
Measured: Blood samples are collected at pre- (baseline), immediately post, 1-hour post drop-landing/control exercise in main trials.
Secondary outcomes (5)
Serum dickkopf Wnt signaling pathway inhibitor 1 (DKK1) concentration
Serum DKK1 concentration is quantified using an enzyme-linked immunosorbent assay (ELISA) and reported in picograms per milliliter (pg/mL).
Measured: Blood samples are collected at pre- (baseline), immediately post, 1-hour post drop-landing/control exercise in main trials.
Serum osteoprotegerin (OPG) concentration
Serum OPG concentration is quantified using an enzyme-linked immunosorbent assay (ELISA) and reported in picograms per milliliter (pg/mL).
Measured: Blood samples are collected at pre- (baseline), immediately post, 1-hour post drop-landing/control exercise in main trials.
Serum irisin concentration
Serum irisin concentration is quantified using an enzyme-linked immunosorbent assay (ELISA) and reported in picograms per milliliter (pg/mL).
Measured: Blood samples are collected at pre- (baseline), immediately post, 1-hour post drop-landing/control exercise in main trials.
Circulating extracellular vesicle (EV) particle concentration and size
EVs are isolated from plasma using ultracentrifugation. EV particle concentration is quantified by nanoparticle tracking analysis (NTA) and reported as particles per milliliter (particles/mL). EV size is also assessed by NTA and reported in nanometers (nm).
Measured: Blood samples are collected at pre- (baseline), immediately post, 1-hour post drop-landing/control exercise in main trials.
Ground reaction force during drop-landing exercise
Ground reaction force is recorded in newtons (N) during each drop-landing exercise using a force plate in the drop-landing trial. Ground reaction force is reported in multiples of body weight (×BW).
Measured: Ground reaction force is recorded during each drop-landing exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start15 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health AdultsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Brooke-Wavell, Loughborough University
- Investigators
- Katherine Brooke-Wavell, Principal investigator, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245225
- Sponsor's protocol ID
- 16204
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Once the analysis is complete and the planned analyses are published, the investigators will consider sharing anonymized IPD upon request, subject to the necessary agreements.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of High Impact Exercise on Bone Metabolism
- ClinicalTrials.gov ID
- NCT07245225
- Acronym / sponsor ID
- 16204
- Conditions
- Health Adults
- Keywords
- Exercise, Bone turnover, Extracellular vesicles, Wnt/β-catenin signaling pathway
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Nov 2025 (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.
The goal of this study is to investigate the acute effects of drop-landing exercise on the bone metabolism biomarkers and extracellular vesicles in healthy young males, in order to gain a deeper understanding of the mechanotransduction mechanisms involved in bone metabolism.
The main question aims to answer:
- Does a single bout acute drop-landing exercise change serum sclerostin, other bone signaling markers, and circulating extracellular vesicles levels?
Participants complete both the drop-landing and control trials in a randomized order, with a minimum washout period of one week between trials. During each trial, blood samples are collected at three time points: pre-, immediately post, and 1-hour post drop-landing/control exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Drop-landing + Control | Experimental | Behavioral: ExerciseAccording to the results of random allocation, participants first perform the drop-landing trial, followed by the control trial, with a minimum interval of one week between the two trials. |
| Arm Control + Drop-landing | Experimental | Behavioral: ExerciseAccording to the results of random allocation, participants first perform the control trial, followed by the drop-landing trial, with a minimum interval of one week between the two trials. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-35 years old
- Healthy
- Male
- Body mass index (BMI) of 18.5-29.9
- Can understand and follow trial instructions
Key exclusion criteria (6 listed)
- Have any uncontrolled cardiovascular or respiratory disease
- Have severe musculoskeletal or neurological disease likely to affect ability to perform an exercise
- Have medical conditions known to affect musculoskeletal health
- Have medications known to affect bone metabolism (e.g., corticosteroids, thyroxine, antiepileptic, and antiretroviral agents)
- Regular (more than once per week) participation in high-intensity resistance or impact-type exercise in the past 6 months
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 |
|---|---|---|
| ExerciseDuring the drop-landing trial, participants perform drop-landing exercises from a block calibrated to generate approximately four times their body weight in vertical ground reaction force upon landing, employing a stiff-landing technique. Each repetition is separated by a 30-second interval, and 10 repetitions are performed as 1 set, totalling 6 sets. There is a 2-minute rest break between each set, during which the participants are asked to sit on a chair. The entire drop-landing exercise is recorded on the force plate. During the control trial, participants are required to walk up and down from the same height block without the requirement to perform the drop-landing movement. The number of repetitions, intervals, and rest breaks are completely consistent with the drop-landing exercise. | Behavioural | Arm Control + Drop-landing, Arm Drop-landing + Control |
Primary outcome
Serum sclerostin concentration
Time frame: Blood samples are collected at pre- (baseline), immediately post, 1-hour post drop-landing/control exercise in main trials.
Serum sclerostin concentration is quantified using an enzyme-linked immunosorbent assay (ELISA) and reported in picograms per milliliter (pg/mL).
5 secondary outcomes
Serum dickkopf Wnt signaling pathway inhibitor 1 (DKK1) concentration
Time frame: Blood samples are collected at pre- (baseline), immediately post, 1-hour post drop-landing/control exercise in main trials.
Serum osteoprotegerin (OPG) concentration
Time frame: Blood samples are collected at pre- (baseline), immediately post, 1-hour post drop-landing/control exercise in main trials.
Serum irisin concentration
Time frame: Blood samples are collected at pre- (baseline), immediately post, 1-hour post drop-landing/control exercise in main trials.
Circulating extracellular vesicle (EV) particle concentration and size
Time frame: Blood samples are collected at pre- (baseline), immediately post, 1-hour post drop-landing/control exercise in main trials.
Ground reaction force during drop-landing exercise
Time frame: Ground reaction force is recorded during each drop-landing exercise.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Undecided. Once the analysis is complete and the planned analyses are published, the investigators will consider sharing anonymized IPD upon request, subject to the necessary agreements.
Related trials for Health Adults
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
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.
Katherine Brooke-Wavell principal investigator
Loughborough University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Health Adults, run by Loughborough University at 1 site in United Kingdom.
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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 24 Nov 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Serum sclerostin concentration (time frame: Blood samples are collected at pre- (baseline), immediately post, 1-hour post drop-landing/control exercise in main trials.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2025.