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Trial registered on ANZCTR
Registration number
ACTRN12619000834156
Ethics application status
Approved
Date submitted
3/05/2019
Date registered
11/06/2019
Date last updated
15/08/2022
Date data sharing statement initially provided
11/06/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Effects of physical activity on bone health to prevent osteoporosis in premenopausal women
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Scientific title
Effects of a physical activity programme on bone mineral density and bone biomarkers in premenopausal women in order to improve bone health and prevent the future onset of osteoporosis
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Secondary ID [1]
298128
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None
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Universal Trial Number (UTN)
U1111-1232-7281
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoporosis
312661
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Osteopenia
312662
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Condition category
Condition code
Musculoskeletal
311160
311160
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0
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Osteoporosis
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Physical Medicine / Rehabilitation
311226
311226
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention group will undergo a physical activity programme, provided online by a smartphone app. The physical activity programme will be completed at home and consists of fast walking (a minimum of 10000 steps) plus jumping (60 rope jumps), to stimulate bone growth.
Regarding what 'fast walking' is considered, although the app will register the step rate, participants will be told to just walk at a speed that impedes talking and impedes a normal conversation. Later on during data analysis we intend to correlate results with the pace registered by the app.
The 10000 steps should be completed daily and will be taken overall (that is, not additionally to current exercise levels).
Adherence to the intervention will be checked daily, as the participants will wear an activity tracker. The intervention will not be individualised, as it will be the same for all the members of the intervention group.
The intervention will last for 6 months.
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Intervention code [1]
314351
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Lifestyle
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Intervention code [2]
314392
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Prevention
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Comparator / control treatment
The control group will NOT follow the physical activity programme. They will continue with their usual lifestyle with no modification. They will also wear the activity tracker, to analyse their physical activity behaviours.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in bone mineral density at femoral neck assessed by MRI scan (Instrument: Hologic Horizon Wi)
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Assessment method [1]
319932
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Timepoint [1]
319932
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6 months after commencement of trial
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Primary outcome [2]
319933
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Change in bone mineral density at lumbar spine assessed by MRI scan (Instrument: Hologic Horizon Wi)
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Assessment method [2]
319933
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Timepoint [2]
319933
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6 months after commencement of trial
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Primary outcome [3]
320017
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Change in serum PINP (bone turnover marker)
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Assessment method [3]
320017
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Timepoint [3]
320017
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3 months after commencement of trial
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Secondary outcome [1]
369923
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Change in body fat assessed by MRI scan (Instrument: Hologic Horizon Wi)
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Assessment method [1]
369923
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Timepoint [1]
369923
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6 months after intervention commencement
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Secondary outcome [2]
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Primary Outcome: Change in serum CTX-I (bone turnover marker)
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Assessment method [2]
370254
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Timepoint [2]
370254
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3 months after commencement of trial
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Secondary outcome [3]
370255
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Primary Outcome: Change in Osteocalcin (bone turnover marker)
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Assessment method [3]
370255
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Timepoint [3]
370255
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3 months after commencement of trial
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Eligibility
Key inclusion criteria
Premenopausal women from 35 to 50 years old who have no history of fragility fractures
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Minimum age
35
Years
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Maximum age
50
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Early-onset menopause, fragility fractures, any condition that impedes physical activity
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed by central randomisation performed by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation computer algorithm (excel's RAND formula)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/07/2019
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Actual
1/07/2019
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Date of last participant enrolment
Anticipated
15/07/2019
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Actual
30/07/2019
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Date of last data collection
Anticipated
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Actual
30/01/2020
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Sample size
Target
60
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Accrual to date
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Final
60
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Recruitment outside Australia
Country [1]
21448
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Spain
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State/province [1]
21448
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Andalucia
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Funding & Sponsors
Funding source category [1]
302659
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Government body
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Name [1]
302659
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European Union - Future Internet Connected Content inCubator
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Address [1]
302659
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Rue Andre Marie Ampere 4
22300 Lannion
France
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Country [1]
302659
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France
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Primary sponsor type
Government body
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Name
European Union - FP7-ICT - Specific Programme "Cooperation": Information and communication technologies INFORMATION AND COMMUNICATION TECHNOLOGIES (ICTs)
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Address
Rue Andre Marie Ampere 4
22300 Lannion
France
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Country
France
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Secondary sponsor category [1]
302607
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None
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Name [1]
302607
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Address [1]
302607
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Country [1]
302607
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303282
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Portal de Ética de la Investigación Biomédica de Andalucía (PEIBA)
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Ethics committee address [1]
303282
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Sede de la antigua Consejería de Salud Avenida de la Innovación s/n. Edificio Arena 1 41020 - Sevilla - Spain
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Ethics committee country [1]
303282
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Spain
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Date submitted for ethics approval [1]
303282
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22/03/2019
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Approval date [1]
303282
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29/03/2019
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Ethics approval number [1]
303282
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Summary
Brief summary
Bone health is affected by physical activity. We intent to research the relationship between physical activity and bone mineral density as well as bone formation biomarkers in order to study how to prevent future osteoporosis in premenopausal women. To do so, a group of 60 women will be divided into 2 groups: the intervention group (who will follow a training programme consisting of fast walking and jumping) and the control group (who will not receive any indications regarding physical activity and will therefore continue with thei daily activities with no modifications on their lifestyle). After the 6-month intervention, the bone health of the participants will be analyzed and correlated to their physical activity patterns.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
93122
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Mr Horacio Sanchez Trigo
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Address
93122
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Facultad de Ciencias de la Educación (A/A Borja Sañudo)
Calle Pirotecnia, 19,
41013 Sevilla (Spain)
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Country
93122
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Spain
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Phone
93122
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+34955420462
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Fax
93122
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Email
93122
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[email protected]
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Contact person for public queries
Name
93123
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Horacio Sanchez Trigo
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Address
93123
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Facultad de Ciencias de la Educación (A/A Borja Sañudo)
Calle Pirotecnia, 19,
41013 Sevilla (Spain)
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Country
93123
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Spain
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Phone
93123
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+34955420462
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Fax
93123
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Email
93123
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[email protected]
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Contact person for scientific queries
Name
93124
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Horacio Sanchez Trigo
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Address
93124
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Facultad de Ciencias de la Educación (A/A Borja Sañudo)
Calle Pirotecnia, 19,
41013 Sevilla (Spain)
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Country
93124
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Spain
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Phone
93124
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+34955420462
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Fax
93124
0
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Email
93124
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
5530
Study protocol
[email protected]
5531
Statistical analysis plan
[email protected]
5532
Informed consent form
[email protected]
5533
Clinical study report
[email protected]
5534
Ethical approval
[email protected]
5535
Analytic code
[email protected]
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Effects of an mHealth physical activity intervention to prevent osteoporosis in premenopausal women. A randomized controlled trial.
2023
https://dx.doi.org/10.1016/j.jsams.2023.09.004
Embase
Assessment of Osteogenic Exercise Efficacy via Bone Turnover Markers in Premenopausal Women: A Randomized Controlled Trial.
2024
https://dx.doi.org/10.1123/ijsnem.2023-0104
N.B. These documents automatically identified may not have been verified by the study sponsor.
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