Acute Effects of High Impact Exercise on Bone Metabolism

November 20, 2025 updated by: Katherine Brooke-Wavell, Loughborough University

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Leicestershire
      • Loughborough, Leicestershire, United Kingdom, LE11 3TU
        • Loughborough University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18-35 years old
  • Healthy
  • Male
  • Body mass index (BMI) of 18.5-29.9
  • Can understand and follow trial instructions

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm Drop-landing + Control
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.
Behavioral: Exercise

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.
Experimental: Arm Control + Drop-landing
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.
Behavioral: Exercise

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Blood samples are collected at pre- (baseline), immediately post, 1-hour post drop-landing/control exercise in main trials.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 DKK1 concentration is quantified using an enzyme-linked immunosorbent assay (ELISA) and reported in picograms per milliliter (pg/mL).
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 OPG concentration is quantified using an enzyme-linked immunosorbent assay (ELISA) and reported in picograms per milliliter (pg/mL).
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.
Serum irisin concentration is quantified using an enzyme-linked immunosorbent assay (ELISA) and reported in picograms per milliliter (pg/mL).
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.
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).
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.
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).
Ground reaction force is recorded during each drop-landing exercise.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Loughborough University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katherine Brooke-Wavell, Loughborough University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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