NCT06282705

Brief 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. 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

11 months

First QC Date

February 7, 2024

Last Update Submit

February 20, 2024

Conditions

Keywords

BoneOsteogenic activityExternal LoadDrop jumps

Outcome Measures

Primary Outcomes (10)

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

    Bone mineral density (BMD)

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

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

    Bone mineral content (BMC)

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

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

    Total bone area

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

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

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

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

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

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

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

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

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

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

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

Secondary Outcomes (8)

  • Peak impact load as assessed by force plates.

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

  • Impulse as assessed by force plates.

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

  • Load rate as assessed by force plates.

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

  • Jump height as assessed by force plates.

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

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

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

  • +3 more secondary outcomes

Study Arms (4)

0 cm Diagonal drop jump

EXPERIMENTAL

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.

Behavioral: Diagonal Drop Jumps 0cm

40 cm diagonal drop jump

EXPERIMENTAL

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 (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.

Behavioral: Diagonal Drop Jumps 40cm

60 cm diagonal drop jump

EXPERIMENTAL

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 (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.

Behavioral: Diagonal Drop Jumps 60cm

Control

NO INTERVENTION

No exercise intervention performed.

Interventions

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.

0 cm Diagonal drop jump

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.

40 cm diagonal drop jump

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.

60 cm diagonal drop jump

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham Trent University

Nottingham, Nottinghamshire, Ng11 8NS, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 29368538BACKGROUND
  • 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.

    PMID: 31832388BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Semi-randomised, matched model.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 7, 2024

First Posted

February 28, 2024

Study Start

January 6, 2023

Primary Completion

December 13, 2023

Study Completion

December 13, 2023

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations