ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000101280

Ethics application status

Approved

Date submitted

6/12/2017

Date registered

23/01/2018

Date last updated

2/07/2021

Date data sharing statement initially provided

8/01/2019

Date results information initially provided

14/02/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Wearable Devices for Assessing Exercise Targeting Bone Health in Post-Menopausal Women with Low Bone Mineral Density

Scientific title

Wearable Devices for Assessing Exercise Targeting Bone Health in Post-Menopausal Women with Low Bone Mineral Density

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1206-1928

Trial acronym

Osteo-Dev

Linked study record

Health condition

Health condition(s) or problem(s) studied:

osteoporosis

osteopenia

Condition category

Condition code

Musculoskeletal

Osteoporosis

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This is a 16-week pilot exercise intervention which will involve progressive increases in the volume and intensity of high-impact exercise, in the form of hopping and skipping. This study is designed to improve bone mineral density in post-menopausal women with low bone mineral density. The hopping will be performed on both legs to avoid unilateral muscle hypertrophy which can compromise gait and result in injury. Participants will attend Monash Health Translation Precinct (MHTP) for one session at the commencement of each cycle (weeks 1, 5 and 9) for instruction on performing the exercise required for that cycle. The final cycle will run for approximately 8 weeks.. Prior to each exercise session at MHTP, participants will be fitted with a prototype wearable device we have developed which will measure forces during the session. These force measurements will be used to personalise the intervention for participants, ensuring that they are progressed throughout the intervention. The prototype device will be worn for the duration of the session at MHTP. Participants will initially complete 3, 30 minute sessions per week during the first block of the intervention. These sessions are to be completed over the course of the week, approximately every second day. Over the course of the intervention participants will gradually progress and build up to 4-5, 45 minute sessions per week, before the final block of 7, one hour sessions per week, with all sessions completed at home with the exception of one session at the beginning of each cycle (weeks 1, 5 and 9). These 7 sessions are to be equally spread over the course of the week.. This session at the MHTP is designed to familiarise participants with the progressively increasing exercise protocol. Participants will also aim to increase both the vertical height, and distance of the hops progressively throughout the study, and this will be controlled by the research team. The exercise sessions target intensity will be approximately 2g (2x body weight force) at the beginning of the trial, progressing to >5g (5x body weight force) at the conclusion of the intervention, These gravitation forces will be assessed by our wearable device.. Each of the sessions at MHTP will be delivered by a qualified exercise physiologist, clinical trial research assistant or PhD student who is coordinating the trial, all of whom are extremely experienced and proficient in the delivery of targeted exercise sessions.. Participant adherence will be measured through use of both subjective and objective methods, in the form of a commercially available fitness activity monitors in the form of FitBit Charge, and the ActiGraph GT3x, along with physical activity and exercise diaries. These activity trackers will be worn for a period of 7 days following the appointment at MHTP.

Intervention code [1]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

bone mineral density will be assessed by dual energy x-ray absorptiometry and quantitative ultrasonography.

Timepoint [1]

week 16

Primary outcome [2]

bone microarchitecture will be assessed by High-resolution peripheral quantitative computed tomograhy and regular peripheral quantitative computed tomography

Timepoint [2]

week 16

Secondary outcome [1]

lean skeletal muscle mass is assessed by dual energy x-ray absorptiometry.

Timepoint [1]

week 16

Secondary outcome [2]

Bone turnover markers, c-terminal telopeptide (B-CTX) and procollagen type 1 propetide (P1NP). Assessed by blood biochemical analysis

Timepoint [2]

weeks 1 and 16

Secondary outcome [3]

Short physical performance battery.

Timepoint [3]

Weeks 1,5,9 and 16

Eligibility

Key inclusion criteria

- Experienced menopause
- Low BMD (<-1.0 T-Score at hip or lumbar spine). Confirmed by DXA scan performed by investigators or self-reported diagnosis in past two years (confirmed by GP)
- Community-dwelling
- GP approval to participate in study
- BMI <30kg/m2
- <150 minutes of self-reported moderate-vigorous physical activity per week

Minimum age

45 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

- Self-reported knee or hip osteoarthritis
- Recent surgery (<6 months)
- Recently undertaken structured exercise regime. Eg; running program/resistance training
- Self-reported inability to walk 400 metres, non-stop and unassisted.
- Non-English speaking
- Regular corticosteroid use (within 3 months)
- Progressive neurological disorder. Eg; Parkinson’s, Alzheimer’s, Multiple Sclerosis etc.
- Lung disease requiring supplemental oxygen
- Any other severe disorder where life expectancy is <12 months
- Myocardial infarction or severe cardiovascular disease
- Any other condition that in the opinion of the investigators may deem the performance of study unsafe

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

5/02/2018

Actual

16/04/2018

Date of last participant enrolment

Anticipated

30/06/2019

Actual

10/04/2019

Date of last data collection

Anticipated

3/11/2019

Actual

31/07/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Monash Medical Centre - Clayton campus - Clayton

Recruitment postcode(s) [1]

3168 - Clayton

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

Scenic Boulevard, Monash University, Clayton, 3800, VIC

Country [1]

Australia

Primary sponsor type

Individual

Name

Professor Peter Ebeling

Address

AC.01, Level 5, Block E, Monash Medical Centre. 246 Clayton Road, Clayton 3168, VIC

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee

Ethics committee address [1]

Level 2, I Block, Monash Medical Centre, 246 Clayton Road, Clayton 3168, Victoria Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/10/2016

Approval date [1]

04/11/2016

Ethics approval number [1]

HREC/16/MonH/364

Summary

Brief summary

This study is a 16-week, progressive exercise intervention, designed to improve bone mineral density in post-menopausal women with low bone health. Participants will have bone density assessments at the beginning and conclusion of the trial, along with strength measurements and blood biochemistry tests throughout the study. All participants recruited to the study will take part in the exercise intervention. Participants will also be fitted with a prototype wearable device which we have developed, capable of measuring the forces experienced by their skeleton during these exercise sessions. The aim of this study is to improve bone mineral density, along with other musculoskeletal factors in older adults.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Peter Ebeling

Address

AC.01 Level 5, Block E, Monash Medical Centre. 246 Clayton Road, Clayton 3168 VIC

Country

Australia

Phone

+61385722919

Fax

[email protected]

Contact person for public queries

Name

Dr David Scott

Address

AC.01 Level 5, Block E, Monash Medical Centre. 246 Clayton Road, Clayton 3168 VIC

Country

Australia

Phone

+61 3 85722919

Fax

[email protected]

Contact person for scientific queries

Name

Dr David Scott

Address

AC.01 Level 5, Block E, Monash Medical Centre. 246 Clayton Road, Clayton 3168 VIC

Country

Australia

Phone

+61385722919

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

To be held by research team

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Ng CA, McMillan LB, Humbert L, Ebeling PR, Scott D... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Feasibility, safety and effectiveness of a pilot 16-week home-based, impact exercise intervention in postmenopausal women with low bone mineral density.	2021	https://dx.doi.org/10.1007/s00198-020-05723-3

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically