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Healthy ParticipantsNCT06282705

Dose Response Effect of Drop Jumps on Bone Characteristics

A study testing Diagonal Drop Jumps 0cm, Diagonal Drop Jumps 40cm and Diagonal Drop Jumps 60cm in people with Healthy Participants and Low Activity Level, run by Nottingham Trent University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study aims to assess if a 16-week drop jump intervention from different heights shows different bone adaptations. Participants will complete four visits over a period of 16 weeks. An initial consultation will be conducted to ensure participants meet the inclusion criteria following participant recruitment. Read more about this study

Who is it for?
Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants, Low Activity Level
What is being tested?
Diagonal Drop Jumps 0cm, Diagonal Drop Jumps 40cm and Diagonal Drop Jumps 60cm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited Kingdom
Study dates
6 Jan 2023to 13 Dec 2023
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 18 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 18 to 25 years old
  • Have a low physical activity status defined as partaking in physical training activities no more than 2x per week.
  • No current regular participation (more than once per week) in exercise programmes known to influence bone inc. gymnastics, dance, court sports, ball sports or racquet sports.
  • Be able to travel to the laboratory using a vehicle or public transport
  • Have the ability to comprehend and understand communication and instruction in English in order to consent and safely participate in study.
  • Have no current unresolved cardiovascular complaints to avoid any cardiovascular complications when performing activities of daily living.

Who cannot join

  • Prescribed medication that influences bone metabolism such as corticosteroids, anticancer drugs, and diabetes related Drugs
  • Joint replacement or prostheses
  • Currently or recently injured
  • Medical conditions adversely affected by exposure to ionising radiation.
  • History of high levels of ionising radiation exposure (e.g., medical treatment).
  • Breastfeeding women, pregnant women and women trying to become pregnant
  • Females who are on any form of contraception that may influence changes in bone
  • Females who have current or previous history of an endocrine disorder

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Nottingham Trent University

    Nottingham, Nottinghamshire, Ng11 8NS

Other trials in United Kingdom

About this study

Official title: Is There a Dose-response Effect on Bone Characteristics in Relation to Drop Jump Height?

The study aims to assess if a 16-week drop jump intervention from different heights shows different bone adaptations. Participants will complete four visits over a period of 16 weeks. An initial consultation will be conducted to ensure participants meet the inclusion criteria following participant recruitment. Estimated load being applied to the bone, will be assessed using non-invasive biomechanical procedures (Inertial Measurement Units, motion analysis, force plates) during drop jumps. Participants will be assigned a drop jump height of 0 cm, 30 cm or 60 cm based on a significant difference in external load at these heights or assigned to a control group where no jumps will be performed. Groups will be matched for body mass to ensure that jump height produces the load. The participants will be asked to perform 40 jumps (20 each side), 4 times per week ensuring jumping bouts are separated by 24 hours. Bone characteristics will be assessed via whole body dual-energy X-ray absorptiometry (DXA) scans and bilateral peripheral Quantitative Computed Tomography (pQCT) scans. Lab based jumping will take place on week 0, week 6, week 12, and week 16 to understand the loading applied during the different jump height groups. pQCT scans will take place on week 0, week 12, week 16 and DXA scans will take place week 0 and week 16. The reasoning of week 12 for pQCT being it may show a significant timepoint for bone formation during the remodelling cycle. During visits participants will complete a health screen, the Bone specific Physical Activity Questionnaire (BPAQ), a food frequency questionnaire and Pittsburgh sleep quality questionnaire alongside consent as tools to monitor any changes to participant lifestyle across the study. Differences in bone characteristics, lab measures and jump heights will be analysed between and within participants.

The present study aims to use varied drop jump heights to identify an osteogenic dose response effect. Drop jumps have been previously used to expose osteogenic effects in research due to the load produced at impact. Is it possible to identify an optimum height for bone response during impact? If so do we then find anything above this height actually has negative or no effect on a group of individuals?

Read the detailed description

There are few studies that attempt to identify optimal exercises for bone health with specific loading variables being quantified. The identification of an osteogenic threshold during single or multiple activity bouts would allow us to understand the optimal volume/magnitude of exercise/loading that causes an osteogenic response. Understanding the optimal exercise characteristics for osteogenesis will subsequently allow specific bone enhancing exercise to be prescribed. Currently, ambiguity exists as in the guidance for optimising bone health through exercise, for example, a recently published position statement on increasing peak bone mass in adolescents recommends that 5-6 months of vigorous physical activity should be performed but does not quantify the specific speed or intensity of activity required.

pQCT and DXA will be used to measure bone characteristics. Both methods are a common way of obtaining data detailing bone architecture and geometry within established research establishments including universities and National Health Service (NHS) trusts. Through pQCT, bone geometry, both cortical and trabecular bone can be measured and as a result, bone quality can be assessed. Bone measurement via pQCT is widely used in research and is a non-invasive method of imaging bone to provide estimates of bone strength in the peripheral skeleton to differentiate cortical from trabecular bone and assess bone geometry and density. DXA is the gold standard method of measuring bone mineral density and is commonly used to assess osteoporosis risk.

In addition, body composition (which will be derived from the DXA) may be associated with bone characteristics due to body mass and composition relating to bone loading and muscle acting on bone to produce bone strain.

Being tested
Diagonal Drop Jumps 0cm, Diagonal Drop Jumps 40cm, Diagonal Drop Jumps 60cm
Keywords
Bone, Osteogenic activity, External Load, Drop jumps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diagonal Drop Jumps 0cmBehavioural

    Participants will complete 4 unsupervised home drop jump sessions per week ( minimum 24 hours between each session) for the duration of the study (e.g., Mon, Wed, Fri, Sun) from a height of 0 cm (floor). They will perform 20 diagonal drop jumps on each side (20 x dropping left and 20 x dropping right) with 30 seconds between each jump. The routine will be demonstrated in full on the first laboratory session. The intervention will last 16 weeks.

  • Diagonal Drop Jumps 40cmBehavioural

    Participants will complete 4 unsupervised home drop jump sessions per week ( minimum 24 hours between each session) for the duration of the study (e.g., Mon, Wed, Fri, Sun) from a height of 40 cm (plyo box). They will perform 20 diagonal drop jumps on each side (20 x dropping left and 20 x dropping right) with 30 seconds between each jump. The routine will be demonstrated in full on the first laboratory session. The intervention will last 16 weeks.

  • Diagonal Drop Jumps 60cmBehavioural

    Participants will complete 4 unsupervised home drop jump sessions per week ( minimum 24 hours between each session) for the duration of the study (e.g., Mon, Wed, Fri, Sun) from a height of 60 cm (plyo box). They will perform 20 diagonal drop jumps on each side (20 x dropping left and 20 x dropping right) with 30 seconds between each jump. The routine will be demonstrated in full on the first laboratory session. The intervention will last 16 weeks.

Study groups in NCT06282705
Study groupRoleWhat they receive
0 cm Diagonal drop jumpExperimentalParticipants will complete 4 unsupervised home drop jump sessions per week ( minimum 24 hours between each session) for the duration of the study (e.g., Mon, Wed, Fri, Sun) from a height of 0 cm (floor). They will perform 20 diagonal drop jumps on each side (20 x dropping left and 20 x dropping right) with 30 seconds between each jump. The routine will be demonstrated in full on the first laboratory session. The intervention will last 16 weeks.
Receives: Behavioral: Diagonal Drop Jumps 0cm
40 cm diagonal drop jumpExperimentalParticipants will complete 4 unsupervised home drop jump sessions per week ( minimum 24 hours between each session) for the duration of the study (e.g., Mon, Wed, Fri, Sun) from a height of 40 cm (plyometric box). They will perform 20 diagonal drop jumps on each side (20 x dropping left and 20 x dropping right) with 30 seconds between each jump. The routine will be demonstrated in full on the first laboratory session. The intervention will last 16 weeks.
Receives: Behavioral: Diagonal Drop Jumps 40cm
60 cm diagonal drop jumpExperimentalParticipants will complete 4 unsupervised home drop jump sessions per week ( minimum 24 hours between each session) for the duration of the study (e.g., Mon, Wed, Fri, Sun) from a height of 60 cm (plyometric box). They will perform 20 diagonal drop jumps on each side (20 x dropping left and 20 x dropping right) with 30 seconds between each jump. The routine will be demonstrated in full on the first laboratory session. The intervention will last 16 weeks.
Receives: Behavioral: Diagonal Drop Jumps 60cm
ControlNo interventionNo exercise intervention performed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BMD as assessed by whole body dual-energy X-ray absorptiometry (DXA).

    Bone mineral density (BMD)

    Measured: From baseline (week 0) to end of intervention (week 16)

  2. BMC as assessed by whole body dual-energy X-ray absorptiometry (DXA).

    Bone mineral content (BMC)

    Measured: From baseline (week 0) to end of intervention (week 16)

  3. Total bone area as assessed by whole body dual-energy X-ray absorptiometry (DXA).

    Total bone area

    Measured: From baseline (week 0) to end of intervention (week 16)

  4. Trabecular density as assessed by peripheral quantitative tomography (pQCT) of tibia.

    Trabecular density measured at the 4% site of the tibia length.

    Measured: From baseline (week 0) to mid intervention (week 12) and end of intervention (week 16)

  5. Cortical thickness as assessed by peripheral quantitative tomography (pQCT) of tibia.

    Cortical thickness measured at the 14% and 38% site of the tibial length.

    Measured: From baseline (week 0) to mid intervention (week 12) and end of intervention (week 16)

  6. Periosteal circumference as assessed by peripheral quantitative tomography (pQCT) of tibia.

    Periosteal circumference measured at the 14% and 38% site of the tibial length.

    Measured: From baseline (week 0) to mid intervention (week 12) and end of intervention (week 16)

  7. Axial bone strength (SSIX) as assessed by peripheral quantitative tomography (pQCT) of tibia.

    SSIX measured at the 14% and 38% site of the tibial length.

    Measured: From baseline (week 0) to mid intervention (week 12) and end of intervention (week 16)

  8. Axial bone strength (SSIY) as assessed by peripheral quantitative tomography (pQCT) of tibia.

    SSIY measured at the 14% and 38% site of the tibial length.

    Measured: From baseline (week 0) to mid intervention (week 12) and end of intervention (week 16)

  9. Polar bone strength (SSIPOL) as assessed by peripheral quantitative tomography (pQCT) of tibia.

    SSIPOL measured at the 14% and 38% site of the tibial length.

    Measured: From baseline (week 0) to mid intervention (week 12) and end of intervention (week 16)

  10. Cortical density as assessed by peripheral quantitative tomography (pQCT) of tibia.

    Cortical density measured at the 14%, 38% and 66% site of the tibial length.

    Measured: From baseline (week 0) to mid intervention (week 12) and end of intervention (week 16)

Secondary outcomes (8)
  1. Peak impact load as assessed by force plates.

    Peak impact load derived from ground reaction force (GRF)

    Measured: From baseline (week 0) to mid intervention (week 6, week 12) and end of intervention (week 16)

  2. Impulse as assessed by force plates.

    Impulse derived from ground reaction force (GRF)

    Measured: From baseline (week 0) to mid intervention (week 6, week 12) and end of intervention (week 16)

  3. Load rate as assessed by force plates.

    Load rate derived from ground reaction force (GRF)

    Measured: From baseline (week 0) to mid intervention (week 6, week 12) and end of intervention (week 16)

  4. Jump height as assessed by force plates.

    Jump height derived from ground reaction force (GRF)

    Measured: From baseline (week 0) to mid intervention (week 6, week 12) and end of intervention (week 16)

  5. Centre of Mass (CoM) velocity as assessed by force plates.

    CoM velocity derived from ground reaction force (GRF)

    Measured: From baseline (week 0) to mid intervention (week 6, week 12) and end of intervention (week 16)

  6. Peak acceleration as assessed by Inertial measurement units (IMU).

    Peak accelerations calculated from tibial mounted IMUs.

    Measured: From baseline (week 0) to mid intervention (week 6, week 12) and end of intervention (week 16)

  7. Stiffness as assessed by motion capture.

    Knee and ankle Stiffness derived from motion capture.

    Measured: From baseline (week 0) to mid intervention (week 6, week 12) and end of intervention (week 16)

  8. Moments as assessed by motion capture.

    Knee and ankle moments derived from motion capture.

    Measured: From baseline (week 0) to mid intervention (week 6, week 12) and end of intervention (week 16)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start6 Jan 2023
  3. Primary completion13 Dec 2023
  4. Study completion13 Dec 2023

Resources

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
Parallel groups
Model description
Semi-randomised, matched model.
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06282705
Sponsor's protocol ID
306347
Status last verified
Feb 2024
First submitted
7 Feb 2024
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kenkre JS, Bassett J. The bone remodelling cycle. Ann Clin Biochem. 2018 May;55(3):308-327. doi: 10.1177/0004563218759371. Epub 2018 Mar 4.

    PubMed 29368538
  • Min SK, Oh T, Kim SH, Cho J, Chung HY, Park DH, Kim CS. Position Statement: Exercise Guidelines to Increase Peak Bone Mass in Adolescents. J Bone Metab. 2019 Nov;26(4):225-239. doi: 10.11005/jbm.2019.26.4.225. Epub 2019 Nov 30.

    PubMed 31832388

Questions about this trial

What is this clinical trial studying?

A study testing Diagonal Drop Jumps 0cm, Diagonal Drop Jumps 40cm and Diagonal Drop Jumps 60cm in people with Healthy Participants and Low Activity Level, run by Nottingham Trent 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 6 inclusion and 8 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 28 Feb 2024. 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?

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?

BMD as assessed by whole body dual-energy X-ray absorptiometry (DXA). (time frame: From baseline (week 0) to end of intervention (week 16)). The study lists 10 primary outcomes in all. 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 NCT06282705, which also lists 2 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 28 Feb 2024.

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