Trial Review

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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 provided
2/07/2021
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] 293538 0
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 305737 0
osteopenia 305738 0
Condition category
Condition code
Musculoskeletal 304957 304957 0 0
Osteoporosis
Musculoskeletal 304958 304958 0 0
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] 299774 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304137 0
bone mineral density will be assessed by dual energy x-ray absorptiometry and quantitative ultrasonography.
Timepoint [1] 304137 0
week 16
Primary outcome [2] 304138 0
bone microarchitecture will be assessed by High-resolution peripheral quantitative computed tomograhy and regular peripheral quantitative computed tomography
Timepoint [2] 304138 0
week 16
Secondary outcome [1] 341079 0
lean skeletal muscle mass is assessed by dual energy x-ray absorptiometry.
Timepoint [1] 341079 0
week 16
Secondary outcome [2] 341396 0
Bone turnover markers, c-terminal telopeptide (B-CTX) and procollagen type 1 propetide (P1NP). Assessed by blood biochemical analysis
Timepoint [2] 341396 0
weeks 1 and 16
Secondary outcome [3] 341397 0
Short physical performance battery.
Timepoint [3] 341397 0
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?
No
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
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9507 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 18248 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 298153 0
University
Name [1] 298153 0
Monash University
Country [1] 298153 0
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] 297361 0
None
Name [1] 297361 0
Address [1] 297361 0
Country [1] 297361 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299166 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 299166 0
Ethics committee country [1] 299166 0
Australia
Date submitted for ethics approval [1] 299166 0
17/10/2016
Approval date [1] 299166 0
04/11/2016
Ethics approval number [1] 299166 0
HREC/16/MonH/364

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79522 0
Prof Peter Ebeling
Address 79522 0
AC.01 Level 5, Block E, Monash Medical Centre. 246 Clayton Road, Clayton 3168 VIC
Country 79522 0
Australia
Phone 79522 0
+61385722919
Fax 79522 0
Email 79522 0
[email protected]
Contact person for public queries
Name 79523 0
David Scott
Address 79523 0
AC.01 Level 5, Block E, Monash Medical Centre. 246 Clayton Road, Clayton 3168 VIC
Country 79523 0
Australia
Phone 79523 0
+61 3 85722919
Fax 79523 0
Email 79523 0
[email protected]
Contact person for scientific queries
Name 79524 0
David Scott
Address 79524 0
AC.01 Level 5, Block E, Monash Medical Centre. 246 Clayton Road, Clayton 3168 VIC
Country 79524 0
Australia
Phone 79524 0
+61385722919
Fax 79524 0
Email 79524 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFeasibility, safety and effectiveness of a pilot 16-week home-based, impact exercise intervention in postmenopausal women with low bone mineral density.2021https://dx.doi.org/10.1007/s00198-020-05723-3
N.B. These documents automatically identified may not have been verified by the study sponsor.