- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07245225
Acute Effects of High Impact Exercise on Bone Metabolism
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Leicestershire
-
Loughborough, Leicestershire, United Kingdom, LE11 3TU
- Loughborough University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
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
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
Sponsor
Investigators
- Principal Investigator: Katherine Brooke-Wavell, Loughborough University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16204
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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