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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
1/11/2019
Date data sharing statement initially provided
11/06/2019
Date results information initially provided
1/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of physical activity on bone health to prevent osteoporosis in premenopausal women
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
Secondary ID [1] 298128 0
None
Universal Trial Number (UTN)
U1111-1232-7281
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 312661 0
Osteopenia 312662 0
Condition category
Condition code
Musculoskeletal 311160 311160 0 0
Osteoporosis
Physical Medicine / Rehabilitation 311226 311226 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 314351 0
Lifestyle
Intervention code [2] 314392 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 319932 0
Change in bone mineral density at femoral neck assessed by MRI scan (Instrument: Hologic Horizon Wi)
Timepoint [1] 319932 0
6 months after commencement of trial
Primary outcome [2] 319933 0
Change in bone mineral density at lumbar spine assessed by MRI scan (Instrument: Hologic Horizon Wi)
Timepoint [2] 319933 0
6 months after commencement of trial
Primary outcome [3] 320017 0
Change in serum PINP (bone turnover marker)
Timepoint [3] 320017 0
3 months after commencement of trial
Secondary outcome [1] 369923 0
Change in body fat assessed by MRI scan (Instrument: Hologic Horizon Wi)
Timepoint [1] 369923 0
6 months after intervention commencement
Secondary outcome [2] 370254 0
Primary Outcome: Change in serum CTX-I (bone turnover marker)
Timepoint [2] 370254 0
3 months after commencement of trial
Secondary outcome [3] 370255 0
Primary Outcome: Change in Osteocalcin (bone turnover marker)
Timepoint [3] 370255 0
3 months after commencement of trial

Eligibility
Key inclusion criteria
Premenopausal women from 35 to 50 years old who have no history of fragility fractures
Minimum age
35 Years
Maximum age
50 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Early-onset menopause, fragility fractures, any condition that impedes physical activity

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed by central randomisation performed by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation computer algorithm (excel's RAND formula)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21448 0
Spain
State/province [1] 21448 0
Andalucia

Funding & Sponsors
Funding source category [1] 302659 0
Government body
Name [1] 302659 0
European Union - Future Internet Connected Content inCubator
Address [1] 302659 0
Rue Andre Marie Ampere 4
22300 Lannion
France
Country [1] 302659 0
France
Primary sponsor type
Government body
Name
European Union - FP7-ICT - Specific Programme "Cooperation": Information and communication technologies INFORMATION AND COMMUNICATION TECHNOLOGIES (ICTs)
Address
Rue Andre Marie Ampere 4
22300 Lannion
France
Country
France
Secondary sponsor category [1] 302607 0
None
Name [1] 302607 0
Address [1] 302607 0
Country [1] 302607 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303282 0
Portal de Ética de la Investigación Biomédica de Andalucía (PEIBA)
Ethics committee address [1] 303282 0
Sede de la antigua Consejería de Salud
Avenida de la Innovación s/n. Edificio Arena 1
41020 - Sevilla - Spain
Ethics committee country [1] 303282 0
Spain
Date submitted for ethics approval [1] 303282 0
22/03/2019
Approval date [1] 303282 0
29/03/2019
Ethics approval number [1] 303282 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93122 0
Mr Horacio Sanchez Trigo
Address 93122 0
Facultad de Ciencias de la Educación (A/A Borja Sañudo)
Calle Pirotecnia, 19,
41013 Sevilla (Spain)
Country 93122 0
Spain
Phone 93122 0
+34678957448
Fax 93122 0
Email 93122 0
horacio.trigo@gmail.com
Contact person for public queries
Name 93123 0
Mr Horacio Sanchez Trigo
Address 93123 0
Facultad de Ciencias de la Educación (A/A Borja Sañudo)
Calle Pirotecnia, 19,
41013 Sevilla (Spain)
Country 93123 0
Spain
Phone 93123 0
+34678957448
Fax 93123 0
Email 93123 0
horacio.trigo@gmail.com
Contact person for scientific queries
Name 93124 0
Mr Horacio Sanchez Trigo
Address 93124 0
Facultad de Ciencias de la Educación (A/A Borja Sañudo)
Calle Pirotecnia, 19,
41013 Sevilla (Spain)
Country 93124 0
Spain
Phone 93124 0
+34678957448
Fax 93124 0
Email 93124 0
horacio.trigo@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Clinical study report
Ethical approval
Analytic code
How or where can supporting documents be obtained?
Type [1] 5530 0
Study protocol
Citation [1] 5530 0
Link [1] 5530 0
Email [1] 5530 0
frasantri@alum.us.es
Other [1] 5530 0
Attachment [1] 5530 0
Type [2] 5531 0
Statistical analysis plan
Citation [2] 5531 0
Link [2] 5531 0
Email [2] 5531 0
frasantri@alum.us.es
Other [2] 5531 0
Attachment [2] 5531 0
Type [3] 5532 0
Informed consent form
Citation [3] 5532 0
Link [3] 5532 0
Email [3] 5532 0
frasantri@alum.us.es
Other [3] 5532 0
Attachment [3] 5532 0
Type [4] 5533 0
Clinical study report
Citation [4] 5533 0
Link [4] 5533 0
Email [4] 5533 0
frasantri@alum.us.es
Other [4] 5533 0
Attachment [4] 5533 0
Type [5] 5534 0
Ethical approval
Citation [5] 5534 0
Link [5] 5534 0
Email [5] 5534 0
frasantri@alum.us.es
Other [5] 5534 0
Attachment [5] 5534 0
Type [6] 5535 0
Analytic code
Citation [6] 5535 0
Link [6] 5535 0
Email [6] 5535 0
frasantri@alum.us.es
Other [6] 5535 0
Attachment [6] 5535 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary